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    Chemistry

    Click the arrow to open the dropdown
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    read-moreClick the button for full data set
    Also known as: 871700-17-3, Gsk1120212, Mekinist, Gsk-1120212, Jtp 74057, Jtp-74057
    Molecular Formula
    C26H23FIN5O4
    Molecular Weight
    615.4  g/mol
    InChI Key
    LIRYPHYGHXZJBZ-UHFFFAOYSA-N
    FDA UNII
    33E86K87QN
    Trametinib
    Trametinib is an orally bioavailable inhibitor of mitogen-activated protein kinase kinase (MAP2K; MAPK/ERK kinase; MEK) 1 and 2, with potential antineoplastic activity. Upon oral administration, trametinib specifically binds to and inhibits MEK 1 and 2, resulting in an inhibition of growth factor-mediated cell signaling and cellular proliferation in various cancers. MEK 1 and 2, dual specificity serine/threonine and tyrosine kinases often upregulated in various cancer cell types, play a key role in the activation of the RAS/RAF/MEK/ERK signaling pathway that regulates cell growth.
    Trametinib is a Kinase Inhibitor. The mechanism of action of trametinib is as a Protein Kinase Inhibitor.
    1 2D Structure

    Trametinib

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N-[3-[3-cyclopropyl-5-(2-fluoro-4-iodoanilino)-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1-yl]phenyl]acetamide
    2.1.2 InChI
    InChI=1S/C26H23FIN5O4/c1-13-22-21(23(31(3)24(13)35)30-20-10-7-15(28)11-19(20)27)25(36)33(17-8-9-17)26(37)32(22)18-6-4-5-16(12-18)29-14(2)34/h4-7,10-12,17,30H,8-9H2,1-3H3,(H,29,34)
    2.1.3 InChI Key
    LIRYPHYGHXZJBZ-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=C2C(=C(N(C1=O)C)NC3=C(C=C(C=C3)I)F)C(=O)N(C(=O)N2C4=CC=CC(=C4)NC(=O)C)C5CC5
    2.2 Other Identifiers
    2.2.1 UNII
    33E86K87QN
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Gsk 1120212

    2. Gsk-1120212

    3. Gsk1120212

    4. Jtp 74057

    5. Jtp-74057

    6. Jtp74057

    2.3.2 Depositor-Supplied Synonyms

    1. 871700-17-3

    2. Gsk1120212

    3. Mekinist

    4. Gsk-1120212

    5. Jtp 74057

    6. Jtp-74057

    7. Gsk 1120212

    8. Trametinib (gsk1120212)

    9. N-[3-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2h)-yl]phenyl]acetamide

    10. Gsk212

    11. Tmt212

    12. Trametinib [usan]

    13. Chebi:75998

    14. Tmt-212

    15. 33e86k87qn

    16. Trametinib (usan)

    17. N-(3-{3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydropyrido[4,3-d]pyrimidin-1(2h)-yl}phenyl)acetamide

    18. N-[3-[3-cyclopropyl-5-(2-fluoro-4-iodoanilino)-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1-yl]phenyl]acetamide

    19. Acetamide, N-(3-(3-cyclopropyl-5-((2-fluoro-4-iodophenyl)amino)-3,4,6,7-tetrahydro-6,8- Dimethyl-2,4,7-trioxopyrido(4,3-d)pyrimidin-1(2h)-yl)phenyl)-

    20. N-(3-(3-cyclopropyl-5-((2-fluoro-4-iodophenyl)amino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydropyrido[4,3-d]pyrimidin-1(2h)-yl)phenyl)acetamide

    21. Unii-33e86k87qn

    22. Trametinib [usan:inn]

    23. Trametinibum

    24. Jtp74057

    25. N-(3-(3-cyclopropyl-5-((2-fluoro-4-iodophenyl)amino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7- Tetrahydropyrido(4,3-d)pyrimidin-1(2h)-yl)phenyl)acetamide

    26. N-(3-(3-cyclopropyl-5-((2-fluoro-4-iodophenyl)amino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydropyrido(4,3-d)pyrimidin-1(2h)-yl)phenyl)acetamide

    27. N-(3-{3-cyclopropyl-5-((2-fluoro-4-iodophenyl)amino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7- Tetrahydropyrido(4,3-d)pyrimidin-1(2h)-yl}phenyl)acetamide

    28. Qom

    29. Trametinib [mi]

    30. Trametinib (gsk1120212jtp 74057)

    31. Trametinib [inn]

    32. Trametinib [vandf]

    33. Trametinib [who-dd]

    34. Schembl170938

    35. Gtpl6495

    36. Gsk1120212 (trametinib)

    37. Chembl2103875

    38. Ex-a022

    39. Bcpp000218

    40. Dtxsid901007381

    41. Hms3295i05

    42. Hms3656j11

    43. Bcp02307

    44. Bdbm50531540

    45. Mfcd17215075

    46. Nsc758246

    47. Nsc800956

    48. S2673

    49. Zinc43100709

    50. Akos015850628

    51. Am90271

    52. Ccg-264976

    53. Cs-0060

    54. Db08911

    55. Ex-5957

    56. Nsc-758246

    57. Nsc-800956

    58. Sb16553

    59. Ncgc00263180-01

    60. Ncgc00263180-07

    61. Ncgc00263180-14

    62. Ac-25891

    63. As-19382

    64. Hy-10999

    65. N-[3-[3-cyclopropyl-5-(2-fluoro-4-iodo-anilino)-6,8-dimethyl-2,4,7-trioxo-pyrido[4,3-d]pyrimidin-1-yl]phenyl]acetamide

    66. Ft-0688438

    67. Sw218089-2

    68. A25168

    69. D10175

    70. Gsk1120212 - Jtp-74057

    71. Gsk1120212,jtp-74057, Gsk212

    72. Sr-01000941589

    73. A1-01871

    74. J-523325

    75. Q7833138

    76. Sr-01000941589-1

    77. Brd-k12343256-001-01-4

    78. Acetamide, N-[3-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2h)-yl]phenyl]-

    79. N-(3-(3-cyclopropyl-5-(2-fluoro-4-iodophenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydropyrido[4,3-d]pyrimidin-1(2h)-yl)phenyl)acetamide

    80. N-[3-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl-2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2h)-yl]phe Nyl]acetamide

    81. N-[3-[3-cyclopropyl-5-[(2-fluoro-4-iodophenyl)amino]-6,8-dimethyl-2,4,7-trioxopyrido[3,4-e]pyrimidin-1-yl]phenyl]acetamide

    82. N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodoanilino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydropyrido[4,3-d]pyrimidin-1(2h)-yl]phenyl}ethanimidic Acid

    83. N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodophenylamino)-6,8-dimethyl-2,4,7-trioxo-3,4,6,7-tetrahydro-2h-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide

    2.4 Create Date
    2006-10-26
    3 Chemical and Physical Properties
    Molecular Weight 615.4 g/mol
    Molecular Formula C26H23FIN5O4
    XLogP33.4
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count5
    Exact Mass615.07788 g/mol
    Monoisotopic Mass615.07788 g/mol
    Topological Polar Surface Area102 Ų
    Heavy Atom Count37
    Formal Charge0
    Complexity1090
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameMekinist
    PubMed HealthTrametinib (By mouth)
    Drug ClassesAntineoplastic Agent
    Drug LabelTrametinib dimethyl sulfoxide is a kinase inhibitor. The chemical name is acetamide, N-[3-[3-cyclopropyl-5-[(2-fluoro-4- iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl- 2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2H)-yl]phenyl]-, compound with 1,1-sul...
    Active IngredientTrametinib dimethyl sulfoxide
    Dosage FormTablet
    RouteOral
    Strengtheq 1mg non-solvated parent; eq 0.5mg non-solvated parent; eq 2mg non-solvated parent
    Market StatusPrescription
    CompanyGlaxosmithkline

    2 of 2  
    Drug NameMekinist
    PubMed HealthTrametinib (By mouth)
    Drug ClassesAntineoplastic Agent
    Drug LabelTrametinib dimethyl sulfoxide is a kinase inhibitor. The chemical name is acetamide, N-[3-[3-cyclopropyl-5-[(2-fluoro-4- iodophenyl)amino]-3,4,6,7-tetrahydro-6,8-dimethyl- 2,4,7-trioxopyrido[4,3-d]pyrimidin-1(2H)-yl]phenyl]-, compound with 1,1-sul...
    Active IngredientTrametinib dimethyl sulfoxide
    Dosage FormTablet
    RouteOral
    Strengtheq 1mg non-solvated parent; eq 0.5mg non-solvated parent; eq 2mg non-solvated parent
    Market StatusPrescription
    CompanyGlaxosmithkline

    4.2 Drug Indication

    Trametinib is indicated for the treatment of unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test [FDA]. In May 2018, it was approved for use with [DB08912] for the treatment of treat anaplastic thyroid cancer caused by an abnormal BRAF V600E gene.

    FDA Label

    * Melanoma:

    Trametinib as monotherapy or in combination with dabrafenib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4. 4 and 5. 1).

    Trametinib monotherapy has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy (see section 5. 1).

    * Adjuvant treatment of melanoma:

    Trametinib in combination with dabrafenib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.

    * Non-small cell lung cancer (NSCLC):

    Trametinib in combination with dabrafenib is indicated for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Trametinib is an anticancer agent which causes apoptosis (or programmed cell death) and inhibits cell proliferation, which are both important in the treatment of malignancies.

    5.2 MeSH Pharmacological Classification

    Antineoplastic Agents

    Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)

    Protein Kinase Inhibitors

    Agents that inhibit PROTEIN KINASES. (See all compounds classified as Protein Kinase Inhibitors.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    TRAMETINIB
    5.3.2 FDA UNII
    33E86K87QN
    5.3.3 Pharmacological Classes
    Protein Kinase Inhibitors [MoA]; Kinase Inhibitor [EPC]
    5.4 ATC Code

    L01EE01

    L - Antineoplastic and immunomodulating agents

    L01 - Antineoplastic agents

    L01E - Protein kinase inhibitors

    L01EE - Mitogen-activated protein kinase (mek) inhibitors

    L01EE01 - Trametinib

    5.5 Absorption, Distribution and Excretion

    Absorption

    Trametinib is readily absorbed. When an oral administration of trametinib was given to patients with BRAF V600 mutation-positive melanoma, peak plasma concentration occurred 1.5 hours post-dose (Tmax). A single 2 mg oral dose has a bioavailability of 72%. When a dose of 2mg/day is given, the peak plasma concentration (Cmax) is 22.2 ng/mL.

    Route of Elimination

    80% of the dose is excreted in the feces. <20% of the dose is excreted in the urine with <0.1% of the excreted dose in the form of the parent compound.

    Volume of Distribution

    Apparent volume of distribution (Vd/F) = 214 L

    Clearance

    Apparent clearance = 4.9 L/h

    5.6 Metabolism/Metabolites

    Trametinib is metabolized predominantly via deacetylation alone or with mono-oxygenation or in combination with glucuronidation biotransformation pathways in vitro. Deacetylation is likely mediated by hydrolytic enzymes, such as carboxyl-esterases or amidases. The cytochrome P450 enzyme system is not involved with the metabolism of trametinib. The predominant circulating component in the plasma is the parent drug.

    5.7 Biological Half-Life

    Elimination half-life = 3.9-4.8 days.

    5.8 Mechanism of Action

    Trametinib is a reversible, allosteric inhibitor of mitogen-activated extracellular signal regulated kinase 1 _(MEK1)_ and _MEK2_ activation and of_ MEK1_ and _MEK2_ kinase activity. MEK proteins are upstream regulators of the extracellular signal-related kinase (ERK) pathway, which promotes cellular proliferation. Trametinib helps with melanoma with the BRAF V600E or V600K as the mutation results in the constitutive activation of the BRAF pathway which includes MEK1 and MEK2.

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    [{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1687804200,"product":"MSN PHARMA-TRAMETINIB DIMETHYLSULFOXIDE","address":"MSN HOUSE, PLOT NO. C-24,INDUSTRIAL HYDERABAD","city":"HYDERABAD","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"TEL AVIV YAFO","customer":"TO THE ORDER","customerCountry":"ISRAEL","quantity":"0.00","actualQuantity":"0.004","unit":"KGS","unitRateFc":"500000","totalValueFC":"1715.4","currency":"USD","unitRateINR":35249964.75,"date":"27-Jun-2023","totalValueINR":"140999.859","totalValueInUsd":"1715.4","indian_port":"HYDERABAD AIR","hs_no":"29337990","bill_no":"0","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"MSN HOUSE, PLOT NO. C-24,INDUSTRIAL HYDERABAD, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707935400,"product":"TRAMETINIB DIMETHYLSULFOXIDE (FORM-M)","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"ZAGREB","customer":"PLIVA HRVATSKA","customerCountry":"CROATIA","quantity":"0.27","actualQuantity":"0.265","unit":"KGS","unitRateFc":"500000","totalValueFC":"131140.6","currency":"USD","unitRateINR":41061244.792452827,"date":"15-Feb-2024","totalValueINR":"10881229.87","totalValueInUsd":"131140.6","indian_port":"Hyderabad Air","hs_no":"29337990","bill_no":"7560829","productDescription":"API","marketType":"REGULATED MARKET","country":"CROATIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722018600,"product":"TRAMETINIB DIMETHYLSULFOXIDE(FORM-M)","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"TORONTO","customer":"APOTEX INC","customerCountry":"CANADA","quantity":"1.25","actualQuantity":"1.25","unit":"KGS","unitRateFc":"550000","totalValueFC":"680684","currency":"USD","unitRateINR":45519284,"date":"27-Jul-2024","totalValueINR":"56899105","totalValueInUsd":"680684","indian_port":"Hyderabad Air","hs_no":"29337990","bill_no":"2764762","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723055400,"product":"TRAMETINIB DIMETHYL SULFOXIDE (GSK1120212B) 51000171 LOT: 291767 (FOC) (REFERANCE STANDARD)","address":"SANDOZ HOUSE,8TH FLOOR,","city":"MUMBAI,MAHARASHTRA","supplier":"NOVARTIS PHARMACEUTICAL MANUFACTURI","supplierCountry":"SLOVENIA","foreign_port":"LJUBLJANA - BRNIK","customer":"NOVARTIS PHARMACEUTICALS CORPORATION","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.00025","unit":"KGS","unitRateFc":"3461840","totalValueFC":"951.8","currency":"EUR","unitRateINR":"319354760","date":"08-Aug-2024","totalValueINR":"79838.69","totalValueInUsd":"951.8","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"4949894","productDescription":"API","marketType":"REGULATED MARKET","country":"SLOVENIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LJUBLJANA - BRNIK","supplierAddress":"NG LLCVEROVSKOVA ULICA 57 1000 LJUBLJANALjubljana, SloveniaSDNF Slovenia","customerAddress":"SANDOZ HOUSE,8TH FLOOR,"}]
    27-Jun-2023
    08-Aug-2024
    KGS
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

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    Quantity (KGS) & Unit rate (USD/KGS) over time

    API Imports and Exports

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    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

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    Drugs in Development

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    Erasca Starts Phase 3 Trial for Naporafenib in Melanoma

    Details:

    ERAS-254 (naporafenib) , an oral Pan-Raf inhibitor is being investigated with trametinib (MEK inhibitor) in patients with NRAS-mutant (NRASm) melanoma.


    Lead Product(s): Naporafenib,Trametinib

    Therapeutic Area: Oncology Brand Name: ERAS-254

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 18, 2024

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    01

    Erasca

    U.S.A
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    Erasca

    U.S.A
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    Lead Product(s) : Naporafenib,Trametinib

    Therapeutic Area : Oncology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Erasca Starts Phase 3 Trial for Naporafenib in Melanoma

    Details : ERAS-254 (naporafenib) , an oral Pan-Raf inhibitor is being investigated with trametinib (MEK inhibitor) in patients with NRAS-mutant (NRASm) melanoma.

    Brand Name : ERAS-254

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    June 18, 2024

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    Erasca Announces Closing of Underwritten Offering of Common Stock and Additional Shares

    Details:

    The net proceeds will be used to advance the clinical development of ERAS-254 (naporafenib), which is being evaluated in late-stage clinical trials for the treatment of RAS Q61X-mutated melanoma.


    Lead Product(s): Naporafenib,Trametinib

    Therapeutic Area: Oncology Brand Name: ERAS-254

    Study Phase: Phase IProduct Type: Small molecule

    Sponsor: J.P. Morgan

    Deal Size: $184.0 million Upfront Cash: Undisclosed

    Deal Type: Public Offering May 21, 2024

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    02

    Erasca

    U.S.A
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    Erasca

    U.S.A
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    Lead Product(s) : Naporafenib,Trametinib

    Therapeutic Area : Oncology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : J.P. Morgan

    Deal Size : $184.0 million

    Deal Type : Public Offering

    DEALS_DEV arrow-down

    Erasca Announces Closing of Underwritten Offering of Common Stock and Additional Shares

    Details : The net proceeds will be used to advance the clinical development of ERAS-254 (naporafenib), which is being evaluated in late-stage clinical trials for the treatment of RAS Q61X-mutated melanoma.

    Brand Name : ERAS-254

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    May 21, 2024

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    Erasca Announces $45 Million Oversubscribed Private Placement Financing

    Details:

    Erasca will use the proceeds to fund R&D of its product candidates, including ERAS-254 (naporafenib) with trametinib for patients with RAS Q61X solid tumors, and other developmental programs.


    Lead Product(s): Naporafenib,Trametinib

    Therapeutic Area: Oncology Brand Name: ERAS-254

    Study Phase: Phase IProduct Type: Small molecule

    Sponsor: BofA Securities

    Deal Size: $45.0 million Upfront Cash: Undisclosed

    Deal Type: Private Placement March 27, 2024

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    Erasca

    U.S.A
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    Lead Product(s) : Naporafenib,Trametinib

    Therapeutic Area : Oncology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : BofA Securities

    Deal Size : $45.0 million

    Deal Type : Private Placement

    DEALS_DEV arrow-down

    Erasca Announces $45 Million Oversubscribed Private Placement Financing

    Details : Erasca will use the proceeds to fund R&D of its product candidates, including ERAS-254 (naporafenib) with trametinib for patients with RAS Q61X solid tumors, and other developmental programs.

    Brand Name : ERAS-254

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    March 27, 2024

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    Erasca Announces Clinical Trial Collaboration and Supply Agreements for Trametinib

    Details:

    The collaboration will support the clinical development of the pan-RAF inhibitor ERAS-254 (naporafenib) in combination with trametinib for the treatment of patients with RAS Q61X solid tumors.


    Lead Product(s): Naporafenib,Trametinib

    Therapeutic Area: Oncology Brand Name: ERAS-254

    Study Phase: Phase IProduct Type: Small molecule

    Sponsor: Novartis Pharmaceuticals Corporation

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration February 14, 2024

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    Erasca

    U.S.A
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    Erasca

    U.S.A
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    Lead Product(s) : Naporafenib,Trametinib

    Therapeutic Area : Oncology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Erasca Announces Clinical Trial Collaboration and Supply Agreements for Trametinib

    Details : The collaboration will support the clinical development of the pan-RAF inhibitor ERAS-254 (naporafenib) in combination with trametinib for the treatment of patients with RAS Q61X solid tumors.

    Brand Name : ERAS-254

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    February 14, 2024

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    Erasca Granted FDA Fast Track Designation for Pan-RAF Inhibitor Naporafenib in Patients with Advanced NRAS-Mutated Melanoma

    Details:

    LXH254 (naporafenib) is a potent and selective pan-RAF inhibitor, it is under phase 3 clinical development in combination with Mekinist (trametinib) for the treatment of NRAS-mutated metastatic melanoma .


    Lead Product(s): Naporafenib,Trametinib

    Therapeutic Area: Oncology Brand Name: ERAS-254

    Study Phase: Phase IProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 11, 2023

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    Erasca

    U.S.A
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    Erasca

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    Lead Product(s) : Naporafenib,Trametinib

    Therapeutic Area : Oncology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Erasca Granted FDA Fast Track Designation for Pan-RAF Inhibitor Naporafenib in Patients with Advan...

    Details : LXH254 (naporafenib) is a potent and selective pan-RAF inhibitor, it is under phase 3 clinical development in combination with Mekinist (trametinib) for the treatment of NRAS-mutated metastatic melanoma .

    Brand Name : ERAS-254

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    December 11, 2023

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    Erasca Doses First Patient in SEACRAFT-1 Phase 1b Trial Evaluating Naporafenib Plus Trametinib in Patients with RAS Q61X Solid Tumors

    Details:

    ERAS-254 (naporafenib) is a potent and selective pan-RAF inhibitor, with a potential first-in-class and best-in-class profile, which is being investigated in combination with MEK inhibitor trametinib (MEKINIST®) in patients with RAS Q61X solid tumors.


    Lead Product(s): Naporafenib,Trametinib

    Therapeutic Area: Oncology Brand Name: ERAS-254

    Study Phase: Phase IProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 29, 2023

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    Erasca

    U.S.A
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    Erasca

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    Lead Product(s) : Naporafenib,Trametinib

    Therapeutic Area : Oncology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Erasca Doses First Patient in SEACRAFT-1 Phase 1b Trial Evaluating Naporafenib Plus Trametinib in ...

    Details : ERAS-254 (naporafenib) is a potent and selective pan-RAF inhibitor, with a potential first-in-class and best-in-class profile, which is being investigated in combination with MEK inhibitor trametinib (MEKINIST®) in patients with RAS Q61X solid tumors.

    Brand Name : ERAS-254

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    August 29, 2023

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    Novartis Tafinlar + Mekinist Approved by FDA for Pediatric Patients With BRAF V600E Low-Grade Glioma, the Most Common Pediatric Brain Cancer

    Details:

    Tafinlar is a combination of dabrafenib mesylate and trametinib that targets two different kinases in the RAS/RAF/MEK/ERK pathway. This combination resulted in greater growth inhibition of BRAF V600 mutation-positive tumor cell lines.


    Lead Product(s): Dabrafenib Mesylate,Trametinib

    Therapeutic Area: Oncology Brand Name: Tafinlar

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable March 16, 2023

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    Novartis Pharmaceuticals Corporation

    Switzerland
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    Novartis Pharmaceuticals Corporation

    Switzerland
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    Lead Product(s) : Dabrafenib Mesylate,Trametinib

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Novartis Tafinlar + Mekinist Approved by FDA for Pediatric Patients With BRAF V600E Low-Grade Glio...

    Details : Tafinlar is a combination of dabrafenib mesylate and trametinib that targets two different kinases in the RAS/RAF/MEK/ERK pathway. This combination resulted in greater growth inhibition of BRAF V600 mutation-positive tumor cell lines.

    Brand Name : Tafinlar

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    March 16, 2023

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    C4 Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial Evaluating CFT1946, an Orally Bioavailable BiDAC™ Degrader, in BRAF V600 Mut...

    Details:

    CFT1946 is an orally bioavailable BiDAC™ degrader designed to be potent and selective against BRAF V600 mutant targets. C4T is advancing CFT1946 to the clinic to study treatment for BRAF V600 mutant solid tumors including NSCLC, colorectal cancer, and melanoma.


    Lead Product(s): CFT1946,Trametinib

    Therapeutic Area: Oncology Brand Name: CFT1946

    Study Phase: Phase I/ Phase IIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 30, 2023

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    C4 Therapeutics

    U.S.A
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    C4 Therapeutics

    U.S.A
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    Lead Product(s) : CFT1946,Trametinib

    Therapeutic Area : Oncology

    Highest Development Status : Phase I/ Phase II

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    C4 Therapeutics Announces First Patient Dosed in Phase 1/2 Clinical Trial Evaluating CFT1946, an O...

    Details : CFT1946 is an orally bioavailable BiDAC™ degrader designed to be potent and selective against BRAF V600 mutant targets. C4T is advancing CFT1946 to the clinic to study treatment for BRAF V600 mutant solid tumors including NSCLC, colorectal cancer, and ...

    Brand Name : CFT1946

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    January 30, 2023

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    Deciphera Pharmaceuticals, Inc. Presents Initial Phase 1 Single Agent Dose Escalation Data for First-in-Class ULK Inhibitor of Autophagy, DCC-3116, at t...

    Details:

    DCC-3116 is orally administered, potent, and highly selective switch-control inhibitor designed to inhibit cancer autophagy, key tumor survival mechanism in cancer cells, by inhibiting ULK1/2 kinases, which have been shown to be enzymes responsible for initiating autophagy.


    Lead Product(s): DCC-3116,Trametinib

    Therapeutic Area: Oncology Brand Name: DCC-3116

    Study Phase: Phase I/ Phase IIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 10, 2022

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    Deciphera Pharmaceuticals

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    Lead Product(s) : DCC-3116,Trametinib

    Therapeutic Area : Oncology

    Highest Development Status : Phase I/ Phase II

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Deciphera Pharmaceuticals, Inc. Presents Initial Phase 1 Single Agent Dose Escalation Data for Fir...

    Details : DCC-3116 is orally administered, potent, and highly selective switch-control inhibitor designed to inhibit cancer autophagy, key tumor survival mechanism in cancer cells, by inhibiting ULK1/2 kinases, which have been shown to be enzymes responsible for i...

    Brand Name : DCC-3116

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 10, 2022

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    Publication in Nature Molecular Psychiatry Supports Genuv’s Alternate Theory for Treatment of Alzheimer’s Disease

    Details:

    SNR1611 (trametinib) was the first drug candidate identified at Genuv with the ATRIVIEW® platform. It showed the most potent neurogenerative and neuroprotective effects in a library of FDA-approved drug compounds.


    Lead Product(s): Trametinib

    Therapeutic Area: Neurology Brand Name: SNR1611

    Study Phase: IND EnablingProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 18, 2022

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    Genuv

    South Korea
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    Genuv

    South Korea
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    Lead Product(s) : Trametinib

    Therapeutic Area : Neurology

    Highest Development Status : IND Enabling

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Publication in Nature Molecular Psychiatry Supports Genuv’s Alternate Theory for Treatment of Al...

    Details : SNR1611 (trametinib) was the first drug candidate identified at Genuv with the ATRIVIEW® platform. It showed the most potent neurogenerative and neuroprotective effects in a library of FDA-approved drug compounds.

    Brand Name : SNR1611

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    August 18, 2022

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    Europe

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    Novartis Europharm Limited

    Switzerland
    World Vaccine Congress
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    Novartis Europharm Limited

    Switzerland
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    Regulatory Info :

    Registration Country : Norway

    Trametinib Dimethyl Sulfoxide

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - EQ 0.5MG

    USFDA APPLICATION NUMBER - 204114

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    DOSAGE - TABLET;ORAL - EQ 1MG **Federal Regis...DOSAGE - TABLET;ORAL - EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 204114

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    US Patents

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    NOVARTIS

    TRAMETINIB DIMETHYL SULFOXIDE

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    Patent Expiration Date : 2027-11-29

    TRAMETINIB DIMETHYL SULFOXIDE

    US Patent Number : 7378423*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 204114

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2027-11-29

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    Patent Expiration Date : 2033-08-30

    TRAMETINIB DIMETHYL SULFOXIDE

    US Patent Number : 10869869

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 204114

    Patent Use Code : U-3184

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    Patent Use Description :

    Patent Expiration Date : 2033-08-30

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    Patent Expiration Date : 2032-07-28

    TRAMETINIB DIMETHYL SULFOXIDE

    US Patent Number : 9399021*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 204114

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2032-07-28

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    Patent Expiration Date : 2032-01-28

    TRAMETINIB DIMETHYL SULFOXIDE

    US Patent Number : 9155706

    Drug Substance Claim :

    Drug Product Claim : Y

    Application Number : 204114

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2032-01-28

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    Patent Expiration Date : 2031-04-15

    TRAMETINIB DIMETHYL SULFOXIDE

    US Patent Number : 8952018*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 204114

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2031-04-15

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    Patent Expiration Date : 2025-06-10

    TRAMETINIB DIMETHYL SULFOXIDE

    US Patent Number : 8835443

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 204114

    Patent Use Code : U-2020

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2025-06-10

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    NOVARTIS

    Switzerland
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    Patent Expiration Date : 2032-07-28

    TRAMETINIB DIMETHYL SULFOXIDE

    US Patent Number : 9155706*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 204114

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    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2032-07-28

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    NOVARTIS

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    NOVARTIS

    Switzerland
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    Patent Expiration Date : 2031-04-15

    TRAMETINIB DIMETHYL SULFOXIDE

    US Patent Number : 8952018*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 204114

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2031-04-15

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    NOVARTIS

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    Switzerland
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    Patent Expiration Date : 2030-10-15

    TRAMETINIB DIMETHYL SULFOXIDE

    US Patent Number : 8703781

    Drug Substance Claim : Y

    Drug Product Claim : Y

    Application Number : 204114

    Patent Use Code : U-2302

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2030-10-15

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    NOVARTIS

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    NOVARTIS

    Switzerland
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    Patent Expiration Date : 2025-06-10

    TRAMETINIB DIMETHYL SULFOXIDE

    US Patent Number : 8835443

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 204114

    Patent Use Code : U-1581

    Delist Requested :

    Patent Use Description : IN COMBINATION WITH DA...

    Patent Expiration Date : 2025-06-10

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    US Exclusivities

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    ODE-182
    2025-04-30
    204114
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    NOVARTIS

    TRAMETINIB DIMETHYL SULFOXIDE

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    NOVARTIS

    Switzerland
    arrow
    SupplySide West 2024
    Not Confirmed

    TRAMETINIB DIMETHYL SULFOXIDE

    Exclusivity Code : ODE-182

    Exclusivity Expiration Date : 2025-04-30

    Application Number : 204114

    Product Number : 1

    Exclusivity Details :

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    ODE-183
    2025-05-04
    204114
    1
    blank

    02

    NOVARTIS

    TRAMETINIB DIMETHYL SULFOXIDE

    arrow
    SupplySide West 2024
    Not Confirmed

    NOVARTIS

    Switzerland
    arrow
    SupplySide West 2024
    Not Confirmed

    TRAMETINIB DIMETHYL SULFOXIDE

    Exclusivity Code : ODE-183

    Exclusivity Expiration Date : 2025-05-04

    Application Number : 204114

    Product Number : 1

    Exclusivity Details :

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    ODE-148
    2024-06-22
    204114
    1
    blank

    03

    NOVARTIS

    TRAMETINIB DIMETHYL SULFOXIDE

    arrow
    SupplySide West 2024
    Not Confirmed

    NOVARTIS

    Switzerland
    arrow
    SupplySide West 2024
    Not Confirmed

    TRAMETINIB DIMETHYL SULFOXIDE

    Exclusivity Code : ODE-148

    Exclusivity Expiration Date : 2024-06-22

    Application Number : 204114

    Product Number : 1

    Exclusivity Details :

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    I-908
    2026-03-16
    204114
    1
    blank

    04

    NOVARTIS

    TRAMETINIB DIMETHYL SULFOXIDE

    arrow
    SupplySide West 2024
    Not Confirmed

    NOVARTIS

    Switzerland
    arrow
    SupplySide West 2024
    Not Confirmed

    TRAMETINIB DIMETHYL SULFOXIDE

    Exclusivity Code : I-908

    Exclusivity Expiration Date : 2026-03-16

    Application Number : 204114

    Product Number : 1

    Exclusivity Details :

    blank

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    NOVARTIS

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    ODE-428
    2030-03-16
    204114
    1
    blank

    05

    NOVARTIS

    TRAMETINIB DIMETHYL SULFOXIDE

    arrow
    SupplySide West 2024
    Not Confirmed

    NOVARTIS

    Switzerland
    arrow
    SupplySide West 2024
    Not Confirmed

    TRAMETINIB DIMETHYL SULFOXIDE

    Exclusivity Code : ODE-428

    Exclusivity Expiration Date : 2030-03-16

    Application Number : 204114

    Product Number : 1

    Exclusivity Details :

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    NOVARTIS

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    I-895
    2025-06-22
    204114
    1
    blank

    06

    NOVARTIS

    TRAMETINIB DIMETHYL SULFOXIDE

    arrow
    SupplySide West 2024
    Not Confirmed

    NOVARTIS

    Switzerland
    arrow
    SupplySide West 2024
    Not Confirmed

    TRAMETINIB DIMETHYL SULFOXIDE

    Exclusivity Code : I-895

    Exclusivity Expiration Date : 2025-06-22

    Application Number : 204114

    Product Number : 1

    Exclusivity Details :

    blank

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    NOVARTIS

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    ODE-182
    2025-04-30
    204114
    2
    blank

    07

    NOVARTIS

    TRAMETINIB DIMETHYL SULFOXIDE

    arrow
    SupplySide West 2024
    Not Confirmed

    NOVARTIS

    Switzerland
    arrow
    SupplySide West 2024
    Not Confirmed

    TRAMETINIB DIMETHYL SULFOXIDE

    Exclusivity Code : ODE-182

    Exclusivity Expiration Date : 2025-04-30

    Application Number : 204114

    Product Number : 2

    Exclusivity Details :

    blank

    Portfolio PDF

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    NOVARTIS

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    • fda
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    ODE-183
    2025-05-04
    204114
    2
    blank

    08

    NOVARTIS

    TRAMETINIB DIMETHYL SULFOXIDE

    arrow
    SupplySide West 2024
    Not Confirmed

    NOVARTIS

    Switzerland
    arrow
    SupplySide West 2024
    Not Confirmed

    TRAMETINIB DIMETHYL SULFOXIDE

    Exclusivity Code : ODE-183

    Exclusivity Expiration Date : 2025-05-04

    Application Number : 204114

    Product Number : 2

    Exclusivity Details :

    blank

    Portfolio PDF

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    ODE-148
    2024-06-22
    204114
    2
    blank

    09

    NOVARTIS

    TRAMETINIB DIMETHYL SULFOXIDE

    arrow
    SupplySide West 2024
    Not Confirmed

    NOVARTIS

    Switzerland
    arrow
    SupplySide West 2024
    Not Confirmed

    TRAMETINIB DIMETHYL SULFOXIDE

    Exclusivity Code : ODE-148

    Exclusivity Expiration Date : 2024-06-22

    Application Number : 204114

    Product Number : 2

    Exclusivity Details :

    blank

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    I-908
    2026-03-16
    204114
    2
    blank

    10

    NOVARTIS

    TRAMETINIB DIMETHYL SULFOXIDE

    arrow
    SupplySide West 2024
    Not Confirmed

    NOVARTIS

    Switzerland
    arrow
    SupplySide West 2024
    Not Confirmed

    TRAMETINIB DIMETHYL SULFOXIDE

    Exclusivity Code : I-908

    Exclusivity Expiration Date : 2026-03-16

    Application Number : 204114

    Product Number : 2

    Exclusivity Details :

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    Only 10 entries up to this point, click to access all click full view read-more
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    Health Canada Patents

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    01

    Gowling WLG (Canada) LLP

    Trametinib
    arrow
    World Vaccine Congress
    Not Confirmed

    Gowling WLG (Canada) LLP

    Canada
    arrow
    World Vaccine Congress
    Not Confirmed

    Patent Expiration Date : 2025-06-10

    Date Granted : 2011-04-05

    Trametinib

    Brand Name : MEKINIST

    Patent Number : 2569850

    Filing Date : 2005-06-10

    Strength per Unit : 0.5 mg

    Dosage Form : Tablet

    Human Or VET : Human

    Route of Administration : Oral

    Patent Expiration Date : 2025-06-10

    Date Granted : 2011-04-05

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    02

    Gowling WLG (Canada) LLP

    Trametinib
    arrow
    World Vaccine Congress
    Not Confirmed

    Gowling WLG (Canada) LLP

    Canada
    arrow
    World Vaccine Congress
    Not Confirmed

    Patent Expiration Date : 2025-06-10

    Date Granted : 2011-04-05

    Trametinib

    Brand Name : MEKINIST

    Patent Number : 2569850

    Filing Date : 2005-06-10

    Strength per Unit : 1.0 mg

    Dosage Form : Tablet

    Human Or VET : Human

    Route of Administration : Oral

    Patent Expiration Date : 2025-06-10

    Date Granted : 2011-04-05

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    03

    Gowling WLG (Canada) LLP

    Trametinib
    arrow
    World Vaccine Congress
    Not Confirmed

    Gowling WLG (Canada) LLP

    Canada
    arrow
    World Vaccine Congress
    Not Confirmed

    Patent Expiration Date : 2025-06-10

    Date Granted : 2011-04-05

    Trametinib

    Brand Name : MEKINIST

    Patent Number : 2569850

    Filing Date : 2005-06-10

    Strength per Unit : 2.0 mg

    Dosage Form : Tablet

    Human Or VET : Human

    Route of Administration : Oral

    Patent Expiration Date : 2025-06-10

    Date Granted : 2011-04-05

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    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

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