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1. 88755-39-9
2. Chembl2000337
3. Runx1/eto Tetramerization-in-1
4. Nsc162496
5. Schembl16211954
6. Dtxsid40864143
7. Bdbm50392853
8. 2,3]dioxol-5-yl)-4-oxobutanoic Acid
9. Nsc-162496
10. Hy-151411
11. Cs-0611487
12. Ft-0627100
13. A937131
14. Butanoic Acid,4-bis[1,3-benzodioxol-5-yl]-4-oxo-
15. 2,4-bis(2h-1,3-benzodioxol-5-yl)-4-oxobutanoic Acid
Molecular Weight | 342.3 g/mol |
---|---|
Molecular Formula | C18H14O7 |
XLogP3 | 2.4 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 7 |
Rotatable Bond Count | 5 |
Exact Mass | 342.07395278 g/mol |
Monoisotopic Mass | 342.07395278 g/mol |
Topological Polar Surface Area | 91.3 Ų |
Heavy Atom Count | 25 |
Formal Charge | 0 |
Complexity | 522 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 1 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3405
Submission : 1979-01-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16273
Submission : 2002-11-25
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4489
Submission : 1982-02-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16622
Submission : 2003-05-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26086
Submission : 2012-05-24
Status : Inactive
Type : II
Certificate Number : R0-CEP 2001-364 - Rev 01
Issue Date : 2005-03-18
Type : TSE
Substance Number : 912
Status : Expired
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 90
Submission : 1954-03-04
Status : Inactive
Type : II
Certificate Number : R1-CEP 2001-085 - Rev 02
Issue Date : 2010-06-01
Type : TSE
Substance Number : 912
Status : Valid
Registration Number : 304MF10126
Registrant's Address : 14191 Myford Road Tustin, CA 92780, USA
Initial Date of Registration : 2022-08-24
Latest Date of Registration : --
Certificate Number : R1-CEP 2001-068 - Rev 00
Issue Date : 2007-04-04
Type : TSE
Substance Number : 912
Status : Suspended by EDQM G...
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4489
Submission : 1982-02-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16273
Submission : 2002-11-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26086
Submission : 2012-05-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16622
Submission : 2003-05-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3405
Submission : 1979-01-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 90
Submission : 1954-03-04
Status : Inactive
Type : II
Registrant Name : Korea BMI Co., Ltd.
Registration Date : 2023-12-27
Registration Number : 20231227-210-J-1591
Manufacturer Name : Korea BMI Co., Ltd.
Manufacturer Address : 11, Cheomdan-ro 7-gil, Jeju-si, Jeju Special Self-Governing Province, Factory 2
Registrant Name : Humedics Co., Ltd.
Registration Date : 2024-03-13
Registration Number : 20240313-210-J-1619
Manufacturer Name : Humedics Co., Ltd.
Manufacturer Address : 17 Biovalley 2-ro, Jecheon-si, Chungcheongbuk-do
Registrant Name : Humedics Co., Ltd.
Registration Date : 2024-03-13
Registration Number : 20240313-210-J-1620
Manufacturer Name : Humedics Co., Ltd.
Manufacturer Address : 17 Biovalley 2-ro, Jecheon-si, Chungcheongbuk-do
Registrant Name : Insung Trading Co., Ltd.
Registration Date : 2021-12-07
Registration Number : 20211207-210-J-1171
Manufacturer Name : Ningbo Linzyme Biosciences C...
Manufacturer Address : 8, Xingshun Road, Binhai New city, Xiaocaoe town, Yuyao
Registrant Name : Korea Chorus Co., Ltd.
Registration Date : 2023-07-04
Registration Number : 20230704-210-J-1516
Manufacturer Name : Ningbo Linzyme Biosciences C...
Manufacturer Address : 8, Xingshun Road, Binhai New City, Xiaocao'e Town, Yuyao@11, Geodudanji 1-gil, Dongna...
Registrant Name : Korea BMI Co., Ltd.
Registration Date : 2024-09-02
Registration Number : 20240902-210-J-1684
Manufacturer Name : Korea BMI Co., Ltd.
Manufacturer Address : 11, Cheomdan-ro 7-gil, Jeju-si, Jeju Special Self-Governing Province
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About the Company : Bioindustria Laboratorio Italiano Medicinali L.I.M. S.p.A. has a long tradition in the pharmaceutical business and specializes in: large and small volume injectables with termin...
About the Company : The company is a professional manufacturer of active biological extracts. We adhere to the market-oriented business philosophy. The international and domestic markets take advantag...
Details:
Vyvgart Hytrulo, a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment, and recombinant human hyaluronidase PH20, It is being developed for CIDP.
Lead Product(s): Efgartigimod Alfa,Hyaluronidase
Therapeutic Area: Neurology Brand Name: Vyvgart Hytrulo
Study Phase: Phase IIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 20, 2024
Lead Product(s) : Efgartigimod Alfa,Hyaluronidase
Therapeutic Area : Neurology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Argenx Progresses Efgartigimod SC in Idiopathic Inflammatory Myopathies Studies
Details : Vyvgart Hytrulo, a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment, and recombinant human hyaluronidase PH20, It is being developed for CIDP.
Brand Name : Vyvgart Hytrulo
Molecule Type : Large molecule
Upfront Cash : Not Applicable
November 20, 2024
Details:
Vyvgart Hytrulo, a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment and recombinant human hyaluronidase PH20, it is indicated for CIPD.
Lead Product(s): Efgartigimod Alfa,Hyaluronidase
Therapeutic Area: Neurology Brand Name: Vyvgart Hytrulo
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Zai Lab
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 11, 2024
Lead Product(s) : Efgartigimod Alfa,Hyaluronidase
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Zai Lab
Deal Size : Not Applicable
Deal Type : Not Applicable
Argenx and Zai Lab Announce Approval of VYVGART for CIDP in China
Details : Vyvgart Hytrulo, a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment and recombinant human hyaluronidase PH20, it is indicated for CIPD.
Brand Name : Vyvgart Hytrulo
Molecule Type : Large molecule
Upfront Cash : Not Applicable
November 11, 2024
Details:
Darzalex Faspro (daratumumab and hyaluronidase-fihj) in is being investgated as monotherapy for the treatment of adult patients with high-risk smouldering multiple myeloma.
Lead Product(s): Daratumumab,Hyaluronidase
Therapeutic Area: Oncology Brand Name: Darzalex Faspro
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 08, 2024
Lead Product(s) : Daratumumab,Hyaluronidase
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Johnson & Johnson Submits DARZALEX® Applications for Myeloma Approval
Details : Darzalex Faspro (daratumumab and hyaluronidase-fihj) in is being investgated as monotherapy for the treatment of adult patients with high-risk smouldering multiple myeloma.
Brand Name : Darzalex Faspro
Molecule Type : Large molecule
Upfront Cash : Not Applicable
November 08, 2024
Details:
Argenx gains access to Halozyme's ENHANZE, a proprietary rHuPH20 enzyme for subcutaneous drug delivery, for six targets, including FcRn target, Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase).
Lead Product(s): Efgartigimod Alfa,Hyaluronidase
Therapeutic Area: Immunology Brand Name: Vyvgart Hytrulo
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Argenx
Deal Size: $370.0 million Upfront Cash: $30.0 million
Deal Type: Collaboration October 03, 2024
Lead Product(s) : Efgartigimod Alfa,Hyaluronidase
Therapeutic Area : Immunology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Argenx
Deal Size : $370.0 million
Deal Type : Collaboration
Halozyme Expands Global Collaboration and License Agreement with Argenx for ENHANZE®
Details : Argenx gains access to Halozyme's ENHANZE, a proprietary rHuPH20 enzyme for subcutaneous drug delivery, for six targets, including FcRn target, Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase).
Brand Name : Vyvgart Hytrulo
Molecule Type : Large molecule
Upfront Cash : $30.0 million
October 03, 2024
Details:
Talvey (talquetamab, CD3 targeting) with Darzalex Faspro (daratumumab and hyaluronidase, CD38 targeting) antibodies are being investigated in patients with relapsed or refractory multiple myeloma.
Lead Product(s): Talquetamab,Daratumumab,Hyaluronidase
Therapeutic Area: Oncology Brand Name: Talvey
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 27, 2024
Lead Product(s) : Talquetamab,Daratumumab,Hyaluronidase
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
TALVEY® And DARZALEX® Combo Shows Durable Responses in Multiple Myeloma
Details : Talvey (talquetamab, CD3 targeting) with Darzalex Faspro (daratumumab and hyaluronidase, CD38 targeting) antibodies are being investigated in patients with relapsed or refractory multiple myeloma.
Brand Name : Talvey
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 27, 2024
Details:
Ocrevus Zunovo (ocrelizumab-hyaluronidase) is a humanised mAb-enzyme designed to target CD20-positive B cells, approved for the treatment of multiple sclerosis.
Lead Product(s): Ocrelizumab,Hyaluronidase
Therapeutic Area: Neurology Brand Name: Ocrevus Zunovo
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 13, 2024
Lead Product(s) : Ocrelizumab,Hyaluronidase
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Approves Ocrevus Zunovo as First Twice-a-Year Subcutaneous Injection for MS
Details : Ocrevus Zunovo (ocrelizumab-hyaluronidase) is a humanised mAb-enzyme designed to target CD20-positive B cells, approved for the treatment of multiple sclerosis.
Brand Name : Ocrevus Zunovo
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 13, 2024
Details:
Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone is approved in the U.S. for patients with newly diagnosed multiple myeloma.
Lead Product(s): Daratumumab,Hyaluronidase,Bortezomib
Therapeutic Area: Oncology Brand Name: Darzalex Faspro
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 30, 2024
Lead Product(s) : Daratumumab,Hyaluronidase,Bortezomib
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
DARZALEX FASPRO® Quadruplet Regimen Approved for Newly Diagnosed Multiple Myeloma
Details : Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone is approved in the U.S. for patients with newly diagnosed multiple myeloma.
Brand Name : Darzalex Faspro
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 30, 2024
Details:
Vyvgart Hytrulo, a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment, and recombinant human hyaluronidase PH20, It is being developed for CIDP.
Lead Product(s): Efgartigimod Alfa,Hyaluronidase
Therapeutic Area: Neurology Brand Name: Vyvgart Hytrulo
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 21, 2024
Lead Product(s) : Efgartigimod Alfa,Hyaluronidase
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Approval of VYVGART Hytrulo for Inflammatory Demyelinating Polyneuropathy
Details : Vyvgart Hytrulo, a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment, and recombinant human hyaluronidase PH20, It is being developed for CIDP.
Brand Name : Vyvgart Hytrulo
Molecule Type : Large molecule
Upfront Cash : Not Applicable
June 21, 2024
Details:
Darzalex Faspro (daratumumab and hyaluronidase-fihj) with bortezomib, lenalidomide, and dexamethasone is evaluated in phase 3 trials for maintenance in newly diagnosed myeloma.
Lead Product(s): Daratumumab,Hyaluronidase,Lenalidomide
Therapeutic Area: Oncology Brand Name: Darzalex Faspro
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 30, 2024
Lead Product(s) : Daratumumab,Hyaluronidase,Lenalidomide
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Johnson & Johnson Submits Biologics License Application for DARZALEX FASPRO®
Details : Darzalex Faspro (daratumumab and hyaluronidase-fihj) with bortezomib, lenalidomide, and dexamethasone is evaluated in phase 3 trials for maintenance in newly diagnosed myeloma.
Brand Name : Darzalex Faspro
Molecule Type : Large molecule
Upfront Cash : Not Applicable
January 30, 2024
Details:
Hyqvia is a liquid medicine containing Recombinant Human Hyaluronidase and immunoglobulins. It is approved as maintenance therapy in patients with chronic inflammatory demyelinating polyneuropathy.
Lead Product(s): Immune Globulin,Hyaluronidase
Therapeutic Area: Neurology Brand Name: HyQvia
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 29, 2024
Lead Product(s) : Immune Globulin,Hyaluronidase
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Takeda’s HYQVIA® Approved in Europe for Chronic Inflammatory Demyelinating Polyneuropathy
Details : Hyqvia is a liquid medicine containing Recombinant Human Hyaluronidase and immunoglobulins. It is approved as maintenance therapy in patients with chronic inflammatory demyelinating polyneuropathy.
Brand Name : HyQvia
Molecule Type : Large molecule
Upfront Cash : Not Applicable
January 29, 2024
Related Excipient Companies
Excipients by Applications
Dosage Form : Capsule, Cream / Lotion / Ointment, Emulsion, Gel, Injectable / Parenteral, Suspension, Tablet
Grade : Parenteral, Oral, Topical
Category : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Application : Emulsifying Agents, Film Formers & Plasticizers, Parenteral, Solubilizers, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : Polysorbate 80 is used as a plasticizer, solubilizer, emulsifier, surfactant, and suspension stabilizer. It is also used in parenteral products.
Application : Parenteral
Excipient Details : Histidine is used in biotherapeutic formulations and protects monoclonal antibodies in both the liquid and lyophilized state.
Pharmacopoeia Ref : USP, EP, BP, JP, ChP
Technical Specs : pH 7.4
Ingredient(s) : L-Histidine Excipient
Dosage Form : Cream / Lotion / Ointment, Emulsion, Injectable / Parenteral, Softgels, Tablet
Grade : Oral, Topical, Parenteral
Category : Film Formers & Plasticizers, Parenteral, Topical
Dosage Form : Capsule, Cream / Lotion / Ointment, Suspension, Tablet
Grade : Oral, Topical & Parenteral
Category : Solubilizers, Surfactant & Foaming Agents
Application : Solubilizers, Surfactant & Foaming Agents
Excipient Details : Polysorbate 80 acts as solubilizer, emulsifier and wetting agent.
Dosage Form : Injectable / Parenteral, Nasal Solution
Grade : Parenteral and Nasal
Category : Parenteral
Application : Parenteral
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : CALCIUM CHLORIDE DIHYDRATE Excipient
Brand Name : Sodium Chloride USP
Application : Parenteral
Excipient Details : A & C's Sodium Chloride is an excipient meeting the USP monograph.
Brand Name : Microlex® CAL-Inj 500
Application : Parenteral
Excipient Details : It is used as Diurectic-osmotic for injectable solution, Dialysis solution, Injectible and Parenteral solution.
Pharmacopoeia Ref : Monograph- Ph.Eur, USP/NF, JP/...
Technical Specs : Not Available
Ingredient(s) : Calcium Chloride Excipient
Dosage Form : Injectable / Parenteral, Nasal Solution, Ophthalmic Solution
Grade : Injectable
Category : Parenteral, Solubilizers
Application : Parenteral, Solubilizers
Excipient Details : Non-Ionic Hydrophilic Surfactant, Emulsifier, Solubilizer
Application : Parenteral
Excipient Details : A&C’s Thimerosal USP 10% aqueous solution is a preservative that meets the USP monograph.
Pharmacopoeia Ref : USP
Technical Specs : 10% (w/v) Aqueous Solution
Ingredient(s) : Thimerosal Excipient
Brand Name : Glycerol Multi-Compendial
Application : Parenteral
Excipient Details : A & C's Glycerol multi-compendial is an excipient that meets USP-NF, EP and BP monographs.
Pharmacopoeia Ref : Multi-compendial
Technical Specs : Not Available
Ingredient(s) : Glycerol Excipient
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