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    Chemistry

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    Also known as: 119413-54-6, Topotecan hcl, Hycamtin, Nogitecan hydrochloride, Topotecan (hydrochloride), Topotecan monohydrochloride
    Molecular Formula
    C23H24ClN3O5
    Molecular Weight
    457.9  g/mol
    InChI Key
    DGHHQBMTXTWTJV-BQAIUKQQSA-N
    FDA UNII
    956S425ZCY
    Topotecan Hydrochloride
    An antineoplastic agent used to treat ovarian cancer. It works by inhibiting DNA TOPOISOMERASES, TYPE I.
    1 2D Structure

    Topotecan Hydrochloride

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (19S)-8-[(dimethylamino)methyl]-19-ethyl-7,19-dihydroxy-17-oxa-3,13-diazapentacyclo[11.8.0.02,11.04,9.015,20]henicosa-1(21),2,4(9),5,7,10,15(20)-heptaene-14,18-dione;hydrochloride
    2.1.2 InChI
    InChI=1S/C23H23N3O5.ClH/c1-4-23(30)16-8-18-20-12(9-26(18)21(28)15(16)11-31-22(23)29)7-13-14(10-25(2)3)19(27)6-5-17(13)24-20;/h5-8,27,30H,4,9-11H2,1-3H3;1H/t23-;/m0./s1
    2.1.3 InChI Key
    DGHHQBMTXTWTJV-BQAIUKQQSA-N
    2.1.4 Canonical SMILES
    CCC1(C2=C(COC1=O)C(=O)N3CC4=CC5=C(C=CC(=C5CN(C)C)O)N=C4C3=C2)O.Cl
    2.1.5 Isomeric SMILES
    CC[C@@]1(C2=C(COC1=O)C(=O)N3CC4=CC5=C(C=CC(=C5CN(C)C)O)N=C4C3=C2)O.Cl
    2.2 Other Identifiers
    2.2.1 UNII
    956S425ZCY
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 9 Dimethylaminomethyl 10 Hydroxycamptothecin

    2. 9-dimethylaminomethyl-10-hydroxycamptothecin

    3. Hycamtamine

    4. Hycamtin

    5. Hydrochloride, Nogitecan

    6. Hydrochloride, Topotecan

    7. Nogitecan Hydrochloride

    8. Nsc 609699

    9. Nsc-609699

    10. Nsc609699

    11. Sk And F 104864 A

    12. Sk And F-104864-a

    13. Sk And F104864a

    14. Skf 104864 A

    15. Skf-104864-a

    16. Skf104864a

    17. Topotecan

    18. Topotecan Monohydrochloride, (s)-isomer

    2.3.2 Depositor-Supplied Synonyms

    1. 119413-54-6

    2. Topotecan Hcl

    3. Hycamtin

    4. Nogitecan Hydrochloride

    5. Topotecan (hydrochloride)

    6. Topotecan Monohydrochloride

    7. Sk&f S-104864-a

    8. Evotopin

    9. Topotecan Hydrochloride [usan]

    10. Nsc 609699

    11. Topotecan Teva

    12. Topotecan Actavis

    13. Topotecan Hospira

    14. Nsc609699

    15. Skf 104864a

    16. Nsc-609699

    17. Nsc-759263

    18. Topotecan (as Hydrochloride)

    19. (s)-10-((dimethylamino)methyl)-4-ethyl-4,9-dihydroxy-1h-pyrano(3',4':6,7)indolizino(1,2-b)quinoline-3,14(4h,12h)-dione Monohydrochloride

    20. 956s425zcy

    21. Sk&f-s-104864-a

    22. Ncgc00095189-01

    23. Hycamtin (tn)

    24. Skf 104864a; Nsc 609669

    25. Dsstox_cid_25952

    26. Dsstox_rid_81248

    27. Dsstox_gsid_45952

    28. 1h-pyrano(3',4':6,7)indolizino(1,2-b)quinoline-3,14(4h,12h)-dione, 10-((dimethylamino)methyl)-4-ethyl-4,9-dihydroxy-, Monohydrochloride, (s)-

    29. Nogitecan Hydrochloride (jan)

    30. Topotecan Hydrochloride (usan)

    31. Skf 104864a (hydrochloride);nsc 609669 (hydrochloride)

    32. Topotecanhydrochloride

    33. Chembl1607

    34. Hycamptamine Hydrochloride

    35. Nogitecan Hydrochloride [jan]

    36. (s)-10-((dimethylamino)methyl)-4-ethyl-4,9-dihydroxy-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4h,12h)-dione Hydrochloride

    37. Smr000466344

    38. Cas-119413-54-6

    39. Sk&f-s-104864a

    40. Nsc 609669

    41. Drg-0288

    42. 9-dimethylaminomethyl-10-hydroxycamptothecin.

    43. Potactasol

    44. Evotropin

    45. Unii-956s425zcy

    46. Nogitecan Hcl

    47. Potactasol (tn)

    48. (s)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4h,12h)-dione Hydrochloride

    49. Topotecan Hydrocholoride

    50. Topotecan Hcl - Hycamtin

    51. Schembl7247

    52. Hycamtin (tn) (glaxosmith)

    53. Mls000759456

    54. Mls001401447

    55. Spectrum1505820

    56. Dtxsid1045952

    57. Skfs 104864a

    58. Hms1922h22

    59. Pharmakon1600-01505820

    60. 10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4h,12h)-dione Hydrochloride

    61. Amy24931

    62. Bcp00930

    63. Skf-104864a

    64. Skf-s 104864-a

    65. Topotecan Hydrochloride [mi]

    66. Tox21_111478

    67. Ccg-37460

    68. Hy-13768a

    69. Mfcd00866235

    70. Ncgc00014925

    71. Nci609699

    72. Nk-211

    73. Nsc759263

    74. S1231

    75. Akos015900415

    76. Sk&f 104864-a

    77. Tox21_111478_1

    78. Ac-1551

    79. Cs-1498

    80. Ks-1410

    81. Nc00177

    82. Nsc 759263

    83. Topotecan Hydrochloride [mart.]

    84. Topotecan Hydrochloride [vandf]

    85. Topotecan Hydrochloride [usp-rs]

    86. Topotecan Hydrochloride [who-dd]

    87. Ncgc00014925-06

    88. Ncgc00095189-02

    89. Ncgc00095189-03

    90. Sw197557-5

    91. T-160

    92. T2795

    93. Topotecan Hydrochloride [orange Book]

    94. D02168

    95. 413t546

    96. E-89/001

    97. 9-dimethylaminomethyl-10-hydroxycamptothecin, Hcl Salt

    98. Q27271753

    99. 9-[(dimethylamino)methyl]-10-hydroxy-(20s)-camptothecin, Hcl

    100. (4s)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1h-pyrano[3',4',6-7]indolizino[1,2-b]quinoline-3,14(4h,12h)-dione

    101. (4s)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4h,12h)-dionehydrochloride (1:1)

    102. (s)-10-((dimethylamino)methyl)-4-ethyl-4,9-dihydroxy-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4h,12h)-dionehydrochloride

    103. (s)-10-((dimethylamino)methyl)-4-ethyl-4,9-dihydroxy-1h-pyrano[3,4:6,7]indolizino[1,2-b]quinoline-3,14(4h,12h)-dione Hydrochloride

    104. (s)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1h-pyrano[3',4':6,7]indolizino[1,2-b]quinoline-3,14(4h,12h)-dionemonohydrochloride

    105. (s)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1h-pyrano[3',4':6,7]indolizino[l,2-b]quinoline-3,14(4h,12h)-dione Monohydrochloride

    106. 1h-pyrano[3',7]indolizino[1,2-b]quinoline- 3,14(4h,12h)-dione, 10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-, Monohydrochloride, (4s)-

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 457.9 g/mol
    Molecular Formula C23H24ClN3O5
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count7
    Rotatable Bond Count3
    Exact Mass457.1404486 g/mol
    Monoisotopic Mass457.1404486 g/mol
    Topological Polar Surface Area103 Ų
    Heavy Atom Count32
    Formal Charge0
    Complexity867
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameTopotecan hydrochloride
    Drug LabelTopotecan hydrochloride is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity.The chemical name for topotecan hydrochloride is (S)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[...
    Active IngredientTopotecan hydrochloride
    Dosage FormInjectable; Solution
    RouteInjection; Intravenous
    Strengtheq 4mg base/4ml (eq 1mg base/ml); eq 4mg base/vial
    Market StatusPrescription
    CompanyHospira; Fresenius Kabi Oncol; Accord Hlthcare; Sun Pharm Inds; Innopharma Licensing; Teva Pharms Usa; Actavis Elizabeth; Fresenius Kabi Usa; Onco Therapies; Sagent Pharms; Dr Reddys Labs; Three Rivers Pharms

    2 of 2  
    Drug NameTopotecan hydrochloride
    Drug LabelTopotecan hydrochloride is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity.The chemical name for topotecan hydrochloride is (S)-10-[(dimethylamino)methyl]-4-ethyl-4,9-dihydroxy-1H-pyrano[...
    Active IngredientTopotecan hydrochloride
    Dosage FormInjectable; Solution
    RouteInjection; Intravenous
    Strengtheq 4mg base/4ml (eq 1mg base/ml); eq 4mg base/vial
    Market StatusPrescription
    CompanyHospira; Fresenius Kabi Oncol; Accord Hlthcare; Sun Pharm Inds; Innopharma Licensing; Teva Pharms Usa; Actavis Elizabeth; Fresenius Kabi Usa; Onco Therapies; Sagent Pharms; Dr Reddys Labs; Three Rivers Pharms

    4.2 Drug Indication

    Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.

    Topotecan is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.

    Hycamtin capsules are indicated as monotherapy for the treatment of adult patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.

    Topotecan monotherapy is indicated for the treatment of patients with relapsed small-cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.

    Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment-free interval to justify treatment with the combination.

    Topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the first-line regimen is not considered appropriate.

    Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.

    Topotecan monotherapy is indicated for the treatment of:

    - patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy

    - patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with thefirst-line regimen is not considered appropriate.

    Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.

    Topotecan monotherapy is indicated for the treatment of:

    - patients with metastatic carcinoma of the ovary after failure of first line or subsequent therapy;

    - patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the first-line regimen is not considered appropriate.

    Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.

    Topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate.

    Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination.

    Topotecan is indicated for the treatment of patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Topoisomerase I Inhibitors

    Compounds that inhibit the activity of DNA TOPOISOMERASE I. (See all compounds classified as Topoisomerase I Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Topoisomerase Inhibitors [MoA]; Topoisomerase Inhibitor [EPC]
    5.3 ATC Code

    L01CE01

    L01XX17

    L01XX17

    L01XX17

    L01XX17

    L01XX17

    L01XX17

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    Fresenius Kabi AB Brunna

    Sweden

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    BioFlorida Conference
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22303

    Submission : 2009-01-06

    Status : Inactive

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    API Reference Price

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    11-Aug-2021
    19-Jul-2024
    KGS
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    Quantity (KGS) & Unit rate (USD/KGS) over time

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    Drugs in Development

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    • Deals
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Essential Pharma & AGC Biologics Partner for Immunotherapy Manufacturing for Neuroblastoma

    Details:

    AGC Biologics will produce Hu1418K322A (Hu14.18), a humanised monoclonal antibody being developed for Essential Pharma for the treatment of high-risk neuroblastoma (HRNB).


    Lead Product(s): Dinutuximab,Cyclophosphamide,Topotecan Hydrochloride

    Therapeutic Area: Oncology Brand Name: Hu14.18K322A

    Study Phase: Phase IIProduct Type: Large molecule

    Sponsor: AGC Biologics

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Agreement June 11, 2024

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    Essential Pharma

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    Lead Product(s) : Dinutuximab,Cyclophosphamide,Topotecan Hydrochloride

    Therapeutic Area : Oncology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : AGC Biologics

    Deal Size : Undisclosed

    Deal Type : Agreement

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    Essential Pharma & AGC Biologics Partner for Immunotherapy Manufacturing for Neuroblastoma

    Details : AGC Biologics will produce Hu1418K322A (Hu14.18), a humanised monoclonal antibody being developed for Essential Pharma for the treatment of high-risk neuroblastoma (HRNB).

    Brand Name : Hu14.18K322A

    Molecule Type : Large molecule

    Upfront Cash : Undisclosed

    June 11, 2024

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    Salarius Updates on Review and Plans to Support Seclidemstat Trials by lowering Costs

    Details:

    SP-2577 (seclidemstat) is an oral LSD1 inhibitor, small molecule drug candidate. It is being evaluated in phase 1 /2 clinical trials for the treatment of Ewing sarcoma.


    Lead Product(s): Seclidemstat,Topotecan Hydrochloride,Cyclophosphamide

    Therapeutic Area: Oncology Brand Name: SP-2577

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

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 22, 2024

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    02

    Salarius Pharmaceuticals

    U.S.A
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    Salarius Pharmaceuticals

    U.S.A
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    Lead Product(s) : Seclidemstat,Topotecan Hydrochloride,Cyclophosphamide

    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

    Salarius Updates on Review and Plans to Support Seclidemstat Trials by lowering Costs

    Details : SP-2577 (seclidemstat) is an oral LSD1 inhibitor, small molecule drug candidate. It is being evaluated in phase 1 /2 clinical trials for the treatment of Ewing sarcoma.

    Brand Name : SP-2577

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    February 22, 2024

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    Synthetic Biologics Announces Presentation at SIOP International Society of Pediatric Oncology on New Preclinical Data Supporting Evaluation of VCN-01 a...

    Details:

    Preclinical results demonstrated that topotecan treatment enhanced VCN-01 oncolytic activity against retinoblastoma. VCN-01, an oncolytic adenovirus expressing hyaluronidase developed by Albumin Shield™ technology.


    Lead Product(s): VCN-01,Topotecan Hydrochloride

    Therapeutic Area: Oncology Brand Name: VCN-01

    Study Phase: PreclinicalProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 30, 2022

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    03

    Theriva Biologics

    U.S.A
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    BioFlorida Conference
    Not Confirmed

    Theriva Biologics

    U.S.A
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    Not Confirmed
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    Lead Product(s) : VCN-01,Topotecan Hydrochloride

    Therapeutic Area : Oncology

    Highest Development Status : Preclinical

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Synthetic Biologics Announces Presentation at SIOP International Society of Pediatric Oncology on ...

    Details : Preclinical results demonstrated that topotecan treatment enhanced VCN-01 oncolytic activity against retinoblastoma. VCN-01, an oncolytic adenovirus expressing hyaluronidase developed by Albumin Shield™ technology.

    Brand Name : VCN-01

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    September 30, 2022

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    Salarius Pharmaceuticals Adds Two Mayo Clinic Sites to its Ongoing Phase 1/2 Trial of Seclidemstat as a Treatment for Ewing’s Sarcoma and FET-Rearrang...

    Details:

    SP-2577 (seclidemstat) is a novel oral, reversible, targeted LSD1 inhibitor that affects gene expression currently being studied in Phase 1/2 clinical studies for the treatment of solid and hematologic cancers where LSD1 is implicated in disease progression.


    Lead Product(s): Seclidemstat,Topotecan Hydrochloride,Cyclophosphamide

    Therapeutic Area: Oncology Brand Name: SP-2577

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

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 22, 2022

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    04

    Salarius Pharmaceuticals

    U.S.A
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    BioFlorida Conference
    Not Confirmed

    Salarius Pharmaceuticals

    U.S.A
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    • WHO-GMP
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    Lead Product(s) : Seclidemstat,Topotecan Hydrochloride,Cyclophosphamide

    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

    Salarius Pharmaceuticals Adds Two Mayo Clinic Sites to its Ongoing Phase 1/2 Trial of Seclidemstat...

    Details : SP-2577 (seclidemstat) is a novel oral, reversible, targeted LSD1 inhibitor that affects gene expression currently being studied in Phase 1/2 clinical studies for the treatment of solid and hematologic cancers where LSD1 is implicated in disease progress...

    Brand Name : SP-2577

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    August 22, 2022

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    Salarius Pharmaceuticals Achieves Dosing Milestone in Ongoing Phase 1/2 Sarcoma Trial

    Details:

    Seclidemstat is a novel, oral, reversible inhibitor of the lysine-specific histone demethylase 1 enzyme (LSD1), an enzyme that has been shown to play a key role in the development and progression of certain cancers.


    Lead Product(s): Seclidemstat,Topotecan Hydrochloride,Cyclophosphamide

    Therapeutic Area: Oncology Brand Name: SP-2577

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

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 29, 2021

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    05

    Salarius Pharmaceuticals

    U.S.A
    arrow
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    Not Confirmed

    Salarius Pharmaceuticals

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Seclidemstat,Topotecan Hydrochloride,Cyclophosphamide

    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

    Salarius Pharmaceuticals Achieves Dosing Milestone in Ongoing Phase 1/2 Sarcoma Trial

    Details : Seclidemstat is a novel, oral, reversible inhibitor of the lysine-specific histone demethylase 1 enzyme (LSD1), an enzyme that has been shown to play a key role in the development and progression of certain cancers.

    Brand Name : SP-2577

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    December 29, 2021

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    Salarius Pharmaceuticals to Present at the Virtual Life Science Investor Forum

    Details:

    Salarius lead candidate, SP-2577 (seclidemstat) is currently advancing a Phase 1/2 dose-expansion clinical trial,used as a treatment for pediatric cancers, sarcomas, and other cancers.


    Lead Product(s): Seclidemstat,Topotecan Hydrochloride,Cyclophosphamide

    Therapeutic Area: Oncology Brand Name: SP-2577

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

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable December 15, 2021

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    06

    Salarius Pharmaceuticals

    U.S.A
    arrow
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    Not Confirmed

    Salarius Pharmaceuticals

    U.S.A
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    Not Confirmed
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    Lead Product(s) : Seclidemstat,Topotecan Hydrochloride,Cyclophosphamide

    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

    Salarius Pharmaceuticals to Present at the Virtual Life Science Investor Forum

    Details : Salarius lead candidate, SP-2577 (seclidemstat) is currently advancing a Phase 1/2 dose-expansion clinical trial,used as a treatment for pediatric cancers, sarcomas, and other cancers.

    Brand Name : SP-2577

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    December 15, 2021

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    Salarius Pharmaceuticals and Nationwide Children’s Hospital Disclose Research Findings from Presentation at 2021 AACR-NCI-EORTC Virtual International ...

    Details:

    Seclidemstat (SP-2577), Salarius’ lead drug candidate, has a differentiated mechanism of action that gives it potent activity in sarcomas compared to another LSD1 inhibitor used in pediatric cancers, sarcomas and other cancers with limited treatment options.


    Lead Product(s): Seclidemstat,Topotecan Hydrochloride,Cyclophosphamide

    Therapeutic Area: Oncology Brand Name: SP-2577

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

    Sponsor: Nationwide Children’s Hospital

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 07, 2021

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    07

    Salarius Pharmaceuticals

    U.S.A
    arrow
    BioFlorida Conference
    Not Confirmed

    Salarius Pharmaceuticals

    U.S.A
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    Not Confirmed
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    • WHO-GMP
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    Lead Product(s) : Seclidemstat,Topotecan Hydrochloride,Cyclophosphamide

    Therapeutic Area : Oncology

    Highest Development Status : Phase I/ Phase II

    Partner/Sponsor/Collaborator : Nationwide Children’s Hospital

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Salarius Pharmaceuticals and Nationwide Children’s Hospital Disclose Research Findings from Pres...

    Details : Seclidemstat (SP-2577), Salarius’ lead drug candidate, has a differentiated mechanism of action that gives it potent activity in sarcomas compared to another LSD1 inhibitor used in pediatric cancers, sarcomas and other cancers with limited treatment op...

    Brand Name : SP-2577

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    October 07, 2021

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    Salarius Pharmaceuticals Receives $2.7 Million in Payment from the Cancer Prevention and Research Institute of Texas

    Details:

    The grant will support development of lead drug candidate, Seclidemstat (SP-2577) is a novel, oral tablet, reversible inhibitor of lysine-specific histone demethylase 1 (LSD1), an enzyme that plays a key role in the development and progression of several cancers.


    Lead Product(s): Seclidemstat,Topotecan Hydrochloride,Cyclophosphamide

    Therapeutic Area: Oncology Brand Name: SP-2577

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

    Sponsor: Cancer Prevention and Research Institute of Texas

    Deal Size: $2.7 million Upfront Cash: Undisclosed

    Deal Type: Funding September 28, 2021

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    08

    Salarius Pharmaceuticals

    U.S.A
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    Not Confirmed

    Salarius Pharmaceuticals

    U.S.A
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    Lead Product(s) : Seclidemstat,Topotecan Hydrochloride,Cyclophosphamide

    Therapeutic Area : Oncology

    Highest Development Status : Phase I/ Phase II

    Partner/Sponsor/Collaborator : Cancer Prevention and Research Institute of Texas

    Deal Size : $2.7 million

    Deal Type : Funding

    DEALS_DEV arrow-down

    Salarius Pharmaceuticals Receives $2.7 Million in Payment from the Cancer Prevention and Research ...

    Details : The grant will support development of lead drug candidate, Seclidemstat (SP-2577) is a novel, oral tablet, reversible inhibitor of lysine-specific histone demethylase 1 (LSD1), an enzyme that plays a key role in the development and progression of several...

    Brand Name : SP-2577

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    September 28, 2021

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    Algernon Pharmaceuticals Files U.S. FDA Pre-IND Meeting Request for Ifenprodil Small Cell Lung Cancer Study

    Details:

    In pre-IND meeting request application, Company is confirming direction it plans to take in development of Ifenprodil as an adjunct to Topotecan for treatment of chemo refractory small cell lung cancer. Ifenprodil is NMDA receptor antagonist specifically targeting GluN2B.


    Lead Product(s): Ifenprodil Tartrate,Topotecan Hydrochloride

    Therapeutic Area: Oncology Brand Name: NP-120

    Study Phase: IND EnablingProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 22, 2021

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    09

    Algernon Pharmaceuticals

    Canada
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    Not Confirmed

    Algernon Pharmaceuticals

    Canada
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    Lead Product(s) : Ifenprodil Tartrate,Topotecan Hydrochloride

    Therapeutic Area : Oncology

    Highest Development Status : IND Enabling

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Algernon Pharmaceuticals Files U.S. FDA Pre-IND Meeting Request for Ifenprodil Small Cell Lung Can...

    Details : In pre-IND meeting request application, Company is confirming direction it plans to take in development of Ifenprodil as an adjunct to Topotecan for treatment of chemo refractory small cell lung cancer. Ifenprodil is NMDA receptor antagonist specifically...

    Brand Name : NP-120

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 22, 2021

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    Aileron Therapeutics Presents New Clinical Data at ESMO Virtual Congress 2021 Supporting ALRN-6924’s Best-in-Class Potential as a Chemoprotective Agen...

    Details:

    A precision medicine-based chemoprotective agent, ALRN-6924 is designed to selectively activate p53 in normal cells, thereby upregulating p21, which pauses cell cycle in normal cells but not in p53-mutated cancer cells.


    Lead Product(s): ALRN-6924,Topotecan Hydrochloride

    Therapeutic Area: Oncology Brand Name: ALRN-6924

    Study Phase: Phase I/ Phase IIProduct Type: Peptide

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 16, 2021

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    10

    Aileron Therapeutics

    U.S.A
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    Not Confirmed

    Aileron Therapeutics

    U.S.A
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    Not Confirmed
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    Lead Product(s) : ALRN-6924,Topotecan Hydrochloride

    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

    Aileron Therapeutics Presents New Clinical Data at ESMO Virtual Congress 2021 Supporting ALRN-6924...

    Details : A precision medicine-based chemoprotective agent, ALRN-6924 is designed to selectively activate p53 in normal cells, thereby upregulating p21, which pauses cell cycle in normal cells but not in p53-mutated cancer cells.

    Brand Name : ALRN-6924

    Molecule Type : Peptide

    Upfront Cash : Not Applicable

    September 16, 2021

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    DOSAGE - SOLUTION;INTRAVENOUS - EQ 1MG BASE/M...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 200199

    read-more

    DOSAGE - SOLUTION;INTRAVENOUS - EQ 3MG BASE/3...DOSAGE - SOLUTION;INTRAVENOUS - EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 200199

    read-more

    DOSAGE - SOLUTION;INTRAVENOUS - EQ 4MG BASE/4...DOSAGE - SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 200199

    read-more

    DOSAGE - SOLUTION;INTRAVENOUS - EQ 4MG BASE/4...DOSAGE - SOLUTION;INTRAVENOUS - EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

    USFDA APPLICATION NUMBER - 200582

    read-more

    DOSAGE - INJECTABLE;INJECTION - EQ 4MG BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 4MG BASE/VIAL

    USFDA APPLICATION NUMBER - 20671

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    DOSAGE - CAPSULE;ORAL - EQ 0.25MG BASE

    USFDA APPLICATION NUMBER - 20981

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    DOSAGE - CAPSULE;ORAL - EQ 1MG BASE

    USFDA APPLICATION NUMBER - 20981

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