CDEK by Data4ThePeople
Sign in Sign up
← All drugs Report issue

vamorolone

Trade name: Agamree

Small moleculeapprovedOrphan Drug FDAFast Track FDA

Approved

Oct 26, 2023

Vamorolone, sold under the brand name Agamree, is a synthetic corticosteroid, which is used for the treatment of Duchenne muscular dystrophy. It is taken by mouth. It is a dual atypical glucocorticoid and antimineralocorticoid. — Wikipedia

Clinical trial activity

12 trials · 11 clinical orgs · 2 marketing orgs

Phase 1
4
Phase 2
7
Phase 3
0
Phase 4
1

Earliest trial started Jan 1, 2015 (NCT02415439)

Timeline

2010s

  1. Dec 2, 2011

    Orphan Drug Designation

  2. Jan 1, 2015

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2016

    Earliest Phase 2 Sponsor(trial)

2020s

  1. Oct 26, 2023

    Bausch Health Companies — Earliest FDA Approval

  2. Oct 26, 2023

    Catalyst Pharmaceuticals, Inc. — Marketing Organization

  3. Oct 26, 2023

    Bausch Health Companies — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedFast trackOct 26, 2023

Chemistry & pharmacology

Loading structure…

SMILES

C[C@@H]1C[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)C3=CC[C@]2(C)[C@@]1(O)C(=O)CO
Mol. weight
356.46 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • vamorolone
  • vamorolone
  • vamorolone
  • vbp15
  • vbp15
  • vbp-15
  • vbp-15

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06713135Phase 4Nov 10, 2024Santhera
NCT06689527Phase 1Aug 13, 2024Nuvisan Pharma Services, Santhera
NCT06649409Phase 1Jun 17, 2024Nuvisan Pharma Services, Santhera
NCT05166109Phase 2Mar 31, 2022ReveraGen BioPharma, Inc., Santhera, University of Pittsburgh
NCT05185622Phase 2Mar 21, 2022ReveraGen BioPharma, Inc., Santhera, University of Calgary
NCT04348890Phase 1/Phase 2 (Phase 2)Sep 1, 2020ReveraGen BioPharma, Inc.
NCT03439670Phase 2Jun 19, 2018Cooperative International Neuromuscular Research Group, European Union, John Walton Muscular Dystrophy Research Centre, Newcastle University, ReveraGen BioPharma, Inc., University of Pittsburgh
NCT03038399Phase 2Jan 1, 2017Cooperative International Neuromuscular Research Group, ReveraGen BioPharma, Inc., University of Pittsburgh
NCT02760277Phase 2Aug 1, 2016Cooperative International Neuromuscular Research Group, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Neurological Disorders and Stroke (NINDS), ReveraGen BioPharma, Inc., University of Pittsburgh
NCT02760264Phase 2Jun 1, 2016Cooperative International Neuromuscular Research Group, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Neurological Disorders and Stroke (NINDS), ReveraGen BioPharma, Inc., University of Pittsburgh
NCT02415439Phase 1Jan 1, 2015ReveraGen BioPharma, Inc.
NCT03863119N/A—ReveraGen BioPharma, Inc.
Showing 12 of 12 trials
Page 1 / 1

Organizations

Research & Development (11)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
ReveraGen BioPharma, Inc.For profit9932015
SantheraFor profit5332022
University of PittsburghAcademic/Hospital5012016
Cooperative International Neuromuscular Research GroupAcademic/Hospital4012016
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Government2012016
National Institute of Neurological Disorders and Stroke (NINDS)Government2012016
Nuvisan Pharma ServicesFor profit2012024
European UnionGovernment1012018
John Walton Muscular Dystrophy Research CentreAcademic/Hospital1012018
Newcastle UniversityAcademic/Hospital1012018
University of CalgaryAcademic/Hospital1012022
11 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
Bausch Health CompaniesFor profitNDAOct 26, 2023
Catalyst Pharmaceuticals, Inc.For profitMKTGOct 26, 2023