Synopsis
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EU WC
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EDQM
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USP
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JP
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Europe
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Canada
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US Medicaid
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1. Vbp15 Compound
1. 13209-41-1
2. Vamorolone [usan]
3. Vbp-15 Free Alcohol
4. 17,21-dihydroxy-16alpha-methylpregna-1,4,9(11)-triene-3,20-dione
5. 16alpha-methyl-9,11-dehydro Prednisolone
6. 8xp29xmb43
7. (8s,10s,13s,14s,16r,17r)-17-hydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-7,8,12,14,15,16-hexahydro-6h-cyclopenta[a]phenanthren-3-one
8. Chembl2348780
9. Vbp15
10. (8s,10s,13s,14s,16r,17r)-17-hydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-6,7,8,10,12,13,14,15,16,17-decahydro-3h-cyclopenta[a]phenanthren-3-one
11. Unii-8xp29xmb43
12. Vbp 15
13. Einecs 236-177-8
14. 16
15. A-methyl-9,11-dehydro Prednisolone
16. Vamorolone [inn]
17. Vamorolone (usan/inn)
18. Vamorolone [who-dd]
19. Vbp15vbp15
20. Schembl143459
21. Gtpl9247
22. Amy7535
23. Dtxsid60927527
24. Bdbm50432396
25. Zinc33650317
26. Db15114
27. Pregna-1,4,9(11)-triene-3,20-dione, 17,21-dihydroxy-16-methyl-, (16.alpha.)-
28. Hy-109017
29. Cs-0030515
30. Dexamethasone Impurity E [ep Impurity]
31. D11000
32. 16.alpha.-methyl-9,11-dehydroprednisolone
33. J-006120
34. Q27089127
35. 17,21-dihydroxy-16.alpha.-methylpregna-1,4,9(11)-triene- 3,20-dione
36. 17.alpha.,21-dihydroxy-16.alpha.-methylpregna-1,4,9(11)-triene-3,20-dione
37. Delta-1,4,9(11)-pregnatriene-17-alpha,21-dihydroxy-16-alpha-methyl-3,20-dione
Molecular Weight | 356.5 g/mol |
---|---|
Molecular Formula | C22H28O4 |
XLogP3 | 2.7 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 2 |
Exact Mass | 356.19875937 g/mol |
Monoisotopic Mass | 356.19875937 g/mol |
Topological Polar Surface Area | 74.6 Ų |
Heavy Atom Count | 26 |
Formal Charge | 0 |
Complexity | 775 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 6 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Treatment of Duchenne muscular dystrophy
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
NDC Package Code : 46439-8771
Start Marketing Date : 2023-12-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
NDC Package Code : 46439-8771
Start Marketing Date : 2023-12-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
About the Company : Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists ...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
Details:
Agamree (vamorolone) is a novel drug candidate with a mode of action based on binding to the mineralcorticosteroid receptor, being developed for the treatment Duchenne muscular dystrophy.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Brand Name: Agamree
Study Phase: Approved FDFProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 08, 2025
Lead Product(s) : Vamorolone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Health Canada Accepts AGAMREE NDA for Duchenne Muscular Dystrophy
Details : Agamree (vamorolone) is a novel drug candidate with a mode of action based on binding to the mineralcorticosteroid receptor, being developed for the treatment Duchenne muscular dystrophy.
Product Name : Agamree
Product Type : Steroid
Upfront Cash : Inapplicable
April 08, 2025
Details:
Idorsia transfers rights to royalties and milestones for Agamree (vamorolone), a dissociative steroid with novel mode of action in patients with Duchenne muscular dystrophy, to R-Bridge Healthcare.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Brand Name: Agamree
Study Phase: Approved FDFProduct Type: Steroid
Sponsor: R-Bridge Healthcare Fund
Deal Size: $30.0 million Upfront Cash: Undisclosed
Deal Type: Agreement January 16, 2025
Lead Product(s) : Vamorolone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : R-Bridge Healthcare Fund
Deal Size : $30.0 million
Deal Type : Agreement
Santhera Pharmaceuticals Updates Royalty Agreement for AGAMREE® (Vamorolone)
Details : Idorsia transfers rights to royalties and milestones for Agamree (vamorolone), a dissociative steroid with novel mode of action in patients with Duchenne muscular dystrophy, to R-Bridge Healthcare.
Product Name : Agamree
Product Type : Steroid
Upfront Cash : Undisclosed
January 16, 2025
Details:
Agamree (vamorolone) is a novel drug candidate with a mode of action based on binding to the mineralcorticosteroid receptor, being developed for the treatment Duchenne muscular dystrophy.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Brand Name: Agamree
Study Phase: Approved FDFProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 14, 2025
Lead Product(s) : Vamorolone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Santhera Receives Positive Recommendation for AGAMREE® in DMD
Details : Agamree (vamorolone) is a novel drug candidate with a mode of action based on binding to the mineralcorticosteroid receptor, being developed for the treatment Duchenne muscular dystrophy.
Product Name : Agamree
Product Type : Steroid
Upfront Cash : Inapplicable
January 14, 2025
Details:
Under the agreement, Clinigen Group will supply and distribute Agamree (vamorolone) in countries where the product is not otherwise commercially available.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Brand Name: Agamree
Study Phase: Approved FDFProduct Type: Steroid
Sponsor: Clinigen Group
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 06, 2025
Lead Product(s) : Vamorolone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Clinigen Group
Deal Size : Undisclosed
Deal Type : Agreement
Santhera, Clinigen Sign Supply, Distribution Deal for AGAMREE® (Vamorolone)
Details : Under the agreement, Clinigen Group will supply and distribute Agamree (vamorolone) in countries where the product is not otherwise commercially available.
Product Name : Agamree
Product Type : Steroid
Upfront Cash : Undisclosed
January 06, 2025
Details:
Agamree (vamorolone) is a novel drug candidate with a mode of action based on binding to the mineralcorticosteroid receptor, being developed for the treatment Duchenne muscular dystrophy.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Brand Name: Agamree
Study Phase: Approved FDFProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 20, 2024
Lead Product(s) : Vamorolone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Santhera Announces Hong Kong Approval of AGAMREE® for Duchenne Muscular Dystrophy
Details : Agamree (vamorolone) is a novel drug candidate with a mode of action based on binding to the mineralcorticosteroid receptor, being developed for the treatment Duchenne muscular dystrophy.
Product Name : Agamree
Product Type : Steroid
Upfront Cash : Inapplicable
December 20, 2024
Details:
Under the agreement, ASTE will supply Agamree (vamorolone) for the treatment of patients with Duchenne muscular dystrophy (DMD) under a Named Patient Program.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Brand Name: Agamree
Study Phase: Approved FDFProduct Type: Steroid
Sponsor: ASTE
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 11, 2024
Lead Product(s) : Vamorolone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : ASTE
Deal Size : Undisclosed
Deal Type : Agreement
Santhera Signs AGAMREE® (Vamorolone) Supply Deal with ASTE in Qatar
Details : Under the agreement, ASTE will supply Agamree (vamorolone) for the treatment of patients with Duchenne muscular dystrophy (DMD) under a Named Patient Program.
Product Name : Agamree
Product Type : Steroid
Upfront Cash : Undisclosed
December 11, 2024
Details:
Agamree (vamorolone) is a novel drug candidate with a mode of action based on binding to the mineralcorticosteroid receptor, being developed for the treatment Duchenne muscular dystrophy.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Brand Name: Agamree
Study Phase: Approved FDFProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 11, 2024
Lead Product(s) : Vamorolone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Santhera Receives NMPA Approval for AGAMREE® (Vamorolone) in Duchenne Muscular Dystrophy
Details : Agamree (vamorolone) is a novel drug candidate with a mode of action based on binding to the mineralcorticosteroid receptor, being developed for the treatment Duchenne muscular dystrophy.
Product Name : Agamree
Product Type : Steroid
Upfront Cash : Inapplicable
December 11, 2024
Details:
Agamree (vamorolone) is a novel drug with a mode of action based on binding to the same receptor as glucocorticoids. It is approved for the treatment of duchenne muscular dystrophy.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Brand Name: Agamree
Study Phase: Approved FDFProduct Type: Steroid
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 01, 2024
Lead Product(s) : Vamorolone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Santhera Gets Approval for AGAMREE® (Vamorolone) for Duchenne Muscular Dystrophy in the UK
Details : Agamree (vamorolone) is a novel drug with a mode of action based on binding to the same receptor as glucocorticoids. It is approved for the treatment of duchenne muscular dystrophy.
Product Name : Agamree
Product Type : Steroid
Upfront Cash : Inapplicable
December 01, 2024
Details:
Santhera's agreement with GENESIS Pharma for Agamree (vamorolone) to commercialize in 20 markets in Central and Eastern Europe. It is indicated for the treatment of Duchenne muscular dystrophy.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Brand Name: Agamree
Study Phase: Approved FDFProduct Type: Steroid
Sponsor: GENESIS Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 09, 2024
Lead Product(s) : Vamorolone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : GENESIS Pharma
Deal Size : Undisclosed
Deal Type : Agreement
Santhera Signs Exclusive AGAMREE® Distribution Deal with GENESIS Pharma
Details : Santhera's agreement with GENESIS Pharma for Agamree (vamorolone) to commercialize in 20 markets in Central and Eastern Europe. It is indicated for the treatment of Duchenne muscular dystrophy.
Product Name : Agamree
Product Type : Steroid
Upfront Cash : Undisclosed
October 09, 2024
Details:
Agamree (vamorolone) is a novel drug with a mode of action based on binding to the same receptor as glucocorticoids. It is approved for the treatment of duchenne muscular dystrophy.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Brand Name: Agamree
Study Phase: Approved FDFProduct Type: Steroid
Sponsor: Santhera Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 06, 2024
Lead Product(s) : Vamorolone
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Santhera Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Santhera Launches AGAMREE® Early Access in China by its Partner Sperogenix
Details : Agamree (vamorolone) is a novel drug with a mode of action based on binding to the same receptor as glucocorticoids. It is approved for the treatment of duchenne muscular dystrophy.
Product Name : Agamree
Product Type : Steroid
Upfront Cash : Inapplicable
October 06, 2024
Regulatory Info : RX
Registration Country : USA
Brand Name : AGAMREE
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 40MG/ML
Packaging :
Approval Date : 2023-10-26
Application Number : 215239
Regulatory Info : RX
Registration Country : USA
RLD : Yes
TE Code :
Brand Name : AGAMREE
Dosage Form : SUSPENSION;ORAL
Dosage Strength : 40MG/ML
Approval Date : 2023-10-26
Application Number : 215239
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Patents & EXCLUSIVITIES
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PharmaCompass offers a list of Vamorolone API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Vamorolone manufacturer or Vamorolone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vamorolone manufacturer or Vamorolone supplier.
PharmaCompass also assists you with knowing the Vamorolone API Price utilized in the formulation of products. Vamorolone API Price is not always fixed or binding as the Vamorolone Price is obtained through a variety of data sources. The Vamorolone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Vamorolone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vamorolone, including repackagers and relabelers. The FDA regulates Vamorolone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vamorolone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Vamorolone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vamorolone supplier is an individual or a company that provides Vamorolone active pharmaceutical ingredient (API) or Vamorolone finished formulations upon request. The Vamorolone suppliers may include Vamorolone API manufacturers, exporters, distributors and traders.
click here to find a list of Vamorolone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Vamorolone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vamorolone API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Vamorolone as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Vamorolone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vamorolone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vamorolone suppliers with NDC on PharmaCompass.
Vamorolone Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Vamorolone GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Vamorolone GMP manufacturer or Vamorolone GMP API supplier for your needs.
A Vamorolone CoA (Certificate of Analysis) is a formal document that attests to Vamorolone's compliance with Vamorolone specifications and serves as a tool for batch-level quality control.
Vamorolone CoA mostly includes findings from lab analyses of a specific batch. For each Vamorolone CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Vamorolone may be tested according to a variety of international standards, such as European Pharmacopoeia (Vamorolone EP), Vamorolone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vamorolone USP).