Vamorolone

also known as 9,11-dehydro dexamethasone · 9,11-dehydrodexamethasone acetate · Agamree · Vamorolona · Vamorolone acetate · Vbp-15 free alcohol · VBP15

Small molecule targets CYP3A4, NR3C1, NR3C2 via activation / inhibition

Developed for: Duchenne muscular dystrophy · Becker muscular dystrophy · ulcerative colitis
Investigated by: ReveraGen BioPharma, Inc. · Santhera Pharmaceuticals · Cooperative International Neuromuscular Research Group · University of Pittsburgh · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · National Institute of Neurological Disorders and Stroke (NINDS)

Regulatory milestones approvals, filings & regulatory actions · 8 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed DMD-related muscular dystrophy 6 milestones
Filed	UK (MHRA)	—	DMD-related muscular dystrophy	2023-03-02	“submitted a marketing authorization application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for vamorolone” reveragen.com ↗ “Santhera Submits Marketing Authorization Application to the UK MHRA for Vamorolone in Duchenne Muscular Dystrophy” santhera.com ↗
Filed	US (FDA)	—	DMD-related muscular dystrophy	2023-01-09	“Food and Drug Administration (FDA) has accepted the new drug application (NDA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD) for filing.” santhera.com ↗
Filed	US (FDA)	—	DMD-related muscular dystrophy	2022-10-27	“Santhera and ReveraGen Complete NDA Submission to FDA for Vamorolone in Duchenne Muscular Dystrophy” santhera.com ↗
Filed	EU (EMA)	—	DMD-related muscular dystrophy	2022-10-03	“Santhera Pharmaceuticals (SIX: SANN) announces that the Company has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for vamorolone” reveragen.com ↗ “has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).” santhera.com ↗ “European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).” santhera.com ↗
Filed	US (FDA)	—	DMD-related muscular dystrophy	2022-06-29	“the clinical module of its rolling new drug application (NDA) for vamorolone in Duchenne muscular dystrophy (DMD) has been submitted to the U.S.” santhera.com ↗
Filed	US (FDA)	—	DMD-related muscular dystrophy	2022-03-29	“announce the initiation of a rolling new drug application (NDA) submission to the U .S. Food and Drug Administration (FDA) for vamorolone for the treatment of Duchenne muscular...” reveragen.com ↗ “Santhera and ReveraGen Start Rolling NDA Submission to the FDA for Vamorolone for the Treatment of Duchenne Muscular Dystrophy” santhera.com ↗
Approved Indication not stated 2 milestones
Approved	EU (EMA)	Agamree	—	2023-12-14	europa.eu ↗
Approved	US (FDA)	AGAMREE	—	2023-10-26	fda.gov ↗

Trials 11

today

US approved 2023

EU approved 2023

NCT06713135 · Ph 4 NCT06689527 · Ph 1 NCT06649409 · Ph 1 NCT05166109 · Ph 2 NCT05185622 · Ph 2 NCT04348890 · Ph 1/2 NCT03038399 · Ph 2 NCT02760277 · Ph 2 NCT02760264 · Ph 2 NCT02415439 · Ph 1

201520162017201820192020202120222023202420252026202720282029

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 13 trials
Phase 1	NCT06689527	Aug → Sep 2024	—	Santhera Pharmaceuticals	Completed	No outcome recorded
Phase 1	NCT06649409	Jun 2024	—	Santhera Pharmaceuticals	Completed	No outcome recorded
Phase 1	NCT02415439	Jan → Nov 2015	—	ReveraGen BioPharma, Inc.	Completed	No outcome recorded
Phase 1/21 trial
Phase 1/2	NCT04348890	Sep 2020 → Sep 2022	ulcerative colitis	ReveraGen BioPharma, Inc.	Withdrawn	No outcome recorded
Phase 25 trials · 1 met primary · 1 missed
Phase 2	NCT05166109	Jul 2022 → Aug 2025	Becker muscular dystrophy	ReveraGen BioPharma, Inc.	Completed	No outcome recorded
Phase 2	NCT05185622	Mar 2022 → Jul 2024	Duchenne muscular dystrophy	Santhera Pharmaceuticals	Completed	No outcome recorded
Phase 2	NCT03038399	Feb 2017 → Apr 2020	Duchenne muscular dystrophy	ReveraGen BioPharma, Inc.	Completed	Missed primary
Phase 2	NCT02760277	Jul 2016 → Apr 2018	Duchenne muscular dystrophy	ReveraGen BioPharma, Inc.	Completed	No outcome recorded
Phase 2	NCT02760264	Jun 2016 → May 2018	Duchenne muscular dystrophy	ReveraGen BioPharma, Inc.	Completed	Met primary
Phase 41 trial
Phase 4	NCT06713135	Nov 2024 → Sep 2028 expected	Duchenne muscular dystrophy	Santhera Pharmaceuticals	Active not recruiting	No outcome recorded
Phase not stated1 trial
—	NCT03863119	—	Duchenne muscular dystrophy	Santhera Pharmaceuticals	Available	No outcome recorded
Comparator or background therapy1 trial
Phase 2	NCT03439670 Comparator	Jun 2018 → Feb 2021	Duchenne muscular dystrophy	ReveraGen BioPharma, Inc.	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 61

Date	Issuer	Release
2026-07-01	Santhera Pharmaceuticals	Results Santhera Notes Topline Results from Catalyst Pharmaceuticals’ Phase 1 Clinical Study of AGAMREE® santhera.com ↗ The study suggests that AGAMREE® delivers glucocorticoid and anti -inflammatory activity, while avoiding significant immunosuppressive effects, supporting its potential use as a treatment across a broad range of chronic inflammatory rare diseases.
2026-06-02	Santhera Pharmaceuticals	Regulatory Santhera Announces Orphan Drug and Priority Review Designations for AGAMREE® (Vamorolone) in South Korea santhera.com ↗ Santhera Pharmaceuticals (SIX: SANN) today notes that AGAMREE has been granted Orphan Drug Designation (ODD) and Global Innovative Products on Fast Track (GIFT) designation by South Korea’s Ministry of Food and Drug Safety (MFDS) for the treatment of Duchenne muscular dystrophy (DMD).
2026-06-02	Nxera Pharma UK Limited	Regulatory Nxera’s Vamorolone Granted Key Regulatory Designations Supporting Faster Access for Duchenne Muscular Dystrophy Patients in South Korea nxera.life ↗ Nxera Pharma Co., Ltd. (“Nxera” or the “Company”) announces that the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea has granted Orphan Drug Designation (ODD) and Global Innovative Products on Fast Track (GIFT) designation to vamorolone for the treatment of Duchenne muscular dystrophy (DM D).
2026-06-02	Nxera Pharma UK Limited	Regulatory Other nxera.life ↗
2026-04-28	Santhera Pharmaceuticals	Regulatory Santhera Announces Positive AIFA Board Decision on Reimbursement of AGAMREE® (vamorolone) in Italy santhera.com ↗ Santhera Pharmaceuticals (SIX: SANN) announces that the Board of Directors of the Italian Medicines Agency, AIFA, has approved the reimbursement of AGAMREE® (vamorolone) for the treatment of patients with Duchenne muscular dystrophy (DMD) aged 4 years and older in Italy.
2026-04-27	Santhera Pharmaceuticals	Regulatory Santhera Receives Positive CHMP Opinion to Expand AGAMREE® (vamorolone) Use in Pediatric DMD Patients Aged Two and Older in the EU santhera.com ↗ This positive CHMP opinion marks an important step towards our goal of making AGAMREE available to every DMD patient who could benefit.
2026-03-09	Santhera Pharmaceuticals	Results AGAMREE® (vamorolone) Data Presented at MDA 2026 Confirm Comparable Long-Term Effectiveness for up to 8 Years of Treatment, with Clinically Meaningful Safety Advantages in Duchenne Muscular Dystrophy santhera.com ↗ AGAMREE® (vamorolone) Data Presented at MDA 2026 Confirm Comparable Long-Term Effectiveness for up to 8 Years of Treatment, with Clinically Meaningful Safety Advantages in Duchenne Muscular Dystrophy
2026-02-27	Santhera Pharmaceuticals	Regulatory Santhera Announces Proposed Inclusion and Reimbursement of AGAMREE® (Vamorolone) within Spain’s National Health System for the Treatment of Duchenne Muscular Dystrophy santhera.com ↗ Santhera Pharmaceuticals (SIX: SANN) today announces that the Spanish Interministerial Commission on Prices of Medicines, has proposed to include AGAMREE® (vamorolone), in the pharmaceutical coverage of the Spanish National Health System, making it eligible for reimbursement.
2026-01-15	Santhera Pharmaceuticals	Regulatory Santhera Receives Swissmedic Approval of AGAMREE® (Vamorolone) for the Treatment of Duchenne Muscular Dystrophy santhera.com ↗ Santhera Pharmaceuticals (SIX: SANN) announces that the Swiss Agency for Therapeutic Products (Swissmedic), has approved AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older.
2025-11-03	Santhera Pharmaceuticals	Results Five-year data of AGAMREE® (vamorolone) in patients with DMD show improved safety profile with comparable effectiveness to standard of care corticosteroids santhera.com ↗ Santhera Pharmaceuticals (SIX: SANN) today reported positive topline results from an analysis of long-term data, including first assessments from the ongoing, open-label, multicenter GUARDIAN study evaluating AGAMREE® (vamorolone) in patients with Duchenne muscular dystrophy (DMD).
2025-10-03	Santhera Pharmaceuticals	Regulatory Santhera Announces Approval in Canada for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy santhera.com ↗ Health Canada has approved AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 4 years and older following Priority Review, marking the first approved treatment for the disease in Canada.
2025-01-16	Santhera Pharmaceuticals	Regulatory Santhera Receives Positive NICE Final Guidance for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy santhera.com ↗ Santhera Receives Positive NICE Final Guidance for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy
2025-01-14	Santhera Pharmaceuticals	Regulatory Santhera Receives Positive Recommendation from Scottish Medicines Consortium for the Use of AGAMREE® (Vamorolone) in Duchenne Muscular Dystrophy Patients in NHS Scotland santhera.com ↗ Santhera Pharmaceuticals (SIX: SANN) announces that the Scottish Medicines Consortium (SMC) has published recommendations that AGAMREE® (vamorolone) is accepted for use within NHS Scotland for the treatment of Duchenne muscular dystrophy (DMD) in patients 4 years of age and older.
2024-12-20	Santhera Pharmaceuticals	Regulatory Santhera Announces Approval in Hong Kong for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy santhera.com ↗ Santhera Pharmaceuticals (SIX: SANN) announces that the Department of Health of Hong Kong, China, has approved AGAMREE® (vamorolone) for use in patients aged 4 years and older.
2024-12-11	Santhera Pharmaceuticals	Regulatory Santhera Announces Approval from China’s NMPA for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy santhera.com ↗ China’s National Medical Products Administration (NMPA) has approved AGAMREE® (vamorolone) for use in China in patients aged 4 years and older.
2024-12-10	Santhera Pharmaceuticals	Regulatory Santhera Receives Positive Recommendation from NICE for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy santhera.com ↗ AGAMREE® has been recommended by NICE for treating Duchenne muscular dystrophy (DMD) in patients 4 years of age and older in England, Wales and Northern Ireland
2024-10-01	Santhera Pharmaceuticals	Results Santhera Announces Positive Topline Results from LIONHEART Study with AGAMREE® (vamorolone) Demonstrating Unique Mineralocorticoid Receptor Antagonism santhera.com ↗
2024-09-24	Santhera Pharmaceuticals	Regulatory Santhera Announces Acceptance by Swissmedic of Marketing Authorization Application for AGAMREE® (vamorolone) in Duchenne Muscular Dystrophy santhera.com ↗ Santhera Pharmaceuticals (SIX: SANN) announces that Swissmedic, the Swiss Agency for Therapeutic Products, has accepted for review the marketing authorization application (MAA) for AGAMREE® (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD).
2024-03-27	Santhera Pharmaceuticals	Regulatory Santhera Announces NDA for Vamorolone in Duchenne Muscular Dystrophy Accepted and Granted Priority Review by China’s NMPA santhera.com ↗ Santhera Pharmaceuticals (SIX: SANN) announces that the China National Medical Products Administration (NMPA) has accepted for priority review the new drug application (NDA) for vamorolone in Duchenne muscular dystrophy (DMD) which was submitted by Sperogenix Therapeutics, Santhera's specialized rare disease partner for China.
2024-02-14	Santhera Pharmaceuticals	Results Santhera Announces Publication of Efficacy, Safety and Tolerability Data with Vamorolone (AGAMREE®) in Patients with Duchenne Muscular Dystrophy in Neurology santhera.com ↗ Results from 112 patients with DMD who completed the study confirm maintenance of efficacy and benefits in safety and tolerability of treatment with vamorolone over 48 weeks
2024-01-12	Santhera Pharmaceuticals	Regulatory Santhera Receives Approval for AGAMREE® (Vamorolone) as a Treatment for Duchenne Muscular Dystrophy in the United Kingdom santhera.com ↗ Approval by the Medicines and Healthcare products Regulatory Agency (MHRA) of AGAMREE® in the United Kingdom follows marketing authorization for this medicine in the EU and U.S.
2023-12-22	ReveraGen BioPharma, Inc.	Regulatory Data from international public/private partnership leads to the first therapy for Duchenne muscular dystrophy approved by both EMA and FDA. reveragen.com ↗ The EMA approved AGAMREE (vamorolone) for Duchenne muscular dystrophy (DMD), ages 4 years and older on 18 December 2023.
2023-12-18	Santhera Pharmaceuticals	Regulatory Santhera’s AGAMREE® (Vamorolone) Approved in the European Union for the Treatment of Duchenne Muscular Dystrophy santhera.com ↗
2023-10-27	Santhera Pharmaceuticals	Regulatory Santhera Receives U.S. FDA Approval of AGAMREE® (vamorolone) for the Treatment of Duchenne Muscular Dystrophy santhera.com ↗ Santhera Pharmaceuticals (SIX: SANN) announce s that the U.S. Food and Drug Administration (FDA) has approved AGAMREE® (vamorolone) oral suspension 40 mg/ml for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older.
2023-10-13	Santhera Pharmaceuticals	Regulatory Santhera Receives Positive CHMP Opinion Recommending Approval of AGAMREE® (vamorolone) for the Treatment of Duchenne Muscular Dystrophy santhera.com ↗ Santhera Pharmaceuticals (SIX: SANN) announces that the CHMP adopted a positive opinion in favor of approval of AGAMREE® (vamorolone) for the treatment of DMD patients aged 4 years and older.
2023-04-25	ReveraGen BioPharma, Inc.	Regulatory Vamorolone NDA mid-cycle review meeting by FDA completed reveragen.com ↗ At the recent mid-cycle review meeting, the FDA indicated that no significant review or safety concerns were noted up to that point in their ongoing review.
2023-03-02	Santhera Pharmaceuticals	Regulatory Santhera Submits Marketing Authorization Application to the UK MHRA for Vamorolone in Duchenne Muscular Dystrophy santhera.com ↗ Santhera Pharmaceuticals (SIX: SANN) announces that it has submitted a marketing authorization application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).
2023-03-02	ReveraGen BioPharma, Inc.	Regulatory Santhera Submits Marketing Authorization Application to the UK MHRA for Vamorolone in Duchenne Muscular Dystrophy reveragen.com ↗ Santhera Pharmaceuticals (SIX: SANN) announces that it has submitted a marketing authorization application (MAA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).
2023-01-09	Santhera Pharmaceuticals	Regulatory Santhera and ReveraGen Announce FDA Acceptance of New Drug Application for Vamorolone in Duchenne Muscular Dystrophy santhera.com ↗
2022-10-31	Santhera Pharmaceuticals	Regulatory European Medicines Agency Validates Santhera’s Marketing Authorization Application for Vamorolone in Duchenne Muscular Dystrophy santhera.com ↗ Santhera Pharmaceuticals (SIX: SANN) announces that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).
2022-10-31	ReveraGen BioPharma, Inc.	Regulatory European Medicines Agency Validates Santhera’s Marketing Authorization Application for Vamorolone in Duchenne Muscular Dystrophy reveragen.com ↗ Santhera Pharmaceuticals (SIX: SANN) announces that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).
2022-10-27	Santhera Pharmaceuticals	Regulatory Santhera and ReveraGen Complete NDA Submission to FDA for Vamorolone in Duchenne Muscular Dystrophy santhera.com ↗
2022-10-03	Santhera Pharmaceuticals	Regulatory Santhera Submits Marketing Authorization Application to the European Medicines Agency for Vamorolone in Duchenne Muscular Dystrophy santhera.com ↗ Santhera Pharmaceuticals (SIX: SANN) announces that the Company has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).
2022-10-03	ReveraGen BioPharma, Inc.	Regulatory Santhera Submits Marketing Authorization Application to the European Medicines Agency for Vamorolone in Duchenne Muscular Dystrophy reveragen.com ↗ Santhera Pharmaceuticals (SIX: SANN) announces that the Company has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).
2022-09-01	Santhera Pharmaceuticals	Results JAMA Neurology Publishes Positive Pivotal Clinical Trial with Vamorolone in Duchenne Muscular Dystrophy santhera.com ↗ Santhera Pharmaceuticals (SIX: SANN) and ReveraGen (US: Private) announce that JAMA Neurology has published positive results of the 24-week primary efficacy and safety analysis from the VISION-DMD study evaluating vamorolone, an investigational drug for the treatment Duchenne muscular dystrophy (DMD).
2022-09-01	ReveraGen BioPharma, Inc.	Results JAMA Neurology Publishes Positive Pivotal Clinical Trial with Vamorolone in Duchenne Muscular Dystrophy reveragen.com ↗ Vamorolone met its primary endpoint by demonstrating statistically significant and clinically relevant improvement in time to stand from floor compared to placebo, the first functional milestone to deteriorate in young children with DMD.
2022-06-29	Santhera Pharmaceuticals	Regulatory Santhera Updates on Ongoing NDA Submission for Vamorolone santhera.com ↗ Santhera Pharmaceuticals (SIX: SANN) announce s that the clinical module of its rolling new drug application (NDA) for vamorolone in Duchenne muscular dystrophy (DMD) has been submitted to the U.S. Food and Drug Administration (FDA).
2022-03-29	Santhera Pharmaceuticals	Regulatory Santhera and ReveraGen Start Rolling NDA Submission to the FDA for Vamorolone for the Treatment of Duchenne Muscular Dystrophy santhera.com ↗
2022-03-29	ReveraGen BioPharma, Inc.	Regulatory Santhera and ReveraGen Start Rolling NDA Submission to the FDA for Vamorolone for the Treatment of Duchenne Muscular Dystrophy reveragen.com ↗
2022-03-15	Santhera Pharmaceuticals	Results Santhera and ReveraGen to Present Efficacy and Safety Data with Vamorolone at 2022 Muscular Dystrophy Association Conference santhera.com ↗
2022-03-15	ReveraGen BioPharma, Inc.	Results Santhera and ReveraGen to Present Efficacy and Safety Data with Vamorolone at 2022 Muscular Dystrophy Association Conference reveragen.com ↗ In th e VISION -DMD study, vamorolone 6 mg/kg/day met the primary endpoint at week 24 , showed sustained efficacy across multiple endpoints over 48 weeks and was well tolerated with a favorable safety profile.
2021-11-23	Santhera Pharmaceuticals	Results Santhera and ReveraGen Announce Positive Topline Results with Vamorolone after Completion of the VISION-DMD Study santhera.com ↗ Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc (US: private) announce new topline results after completion of the VISION-DMD study at week 48.
2021-11-17	Santhera Pharmaceuticals	Regulatory Santhera and ReveraGen Announce Successful FDA Pre-NDA Meeting for Vamorolone in Duchenne Muscular Dystrophy santhera.com ↗ The FDA considered both the proposed clinical efficacy and safety data sufficient for an NDA filing.
2021-06-01	Santhera Pharmaceuticals	Results Santhera and ReveraGen Announce Positive and Statistically Highly Significant Topline Results with Vamorolone in Pivotal VISION-DMD Study santhera.com ↗ Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc (US: private) announce positive key results from the VISION -DMD study, demonstrating robust efficacy across multiple efficacy endpoints and favorable safety and tolerability of vamorolone in the treatment of patients with DMD.
2021-06-01	ReveraGen BioPharma, Inc.	Results Santhera and ReveraGen Announce Positive and Statistically Highly Significant Topline Results with Vamorolone in Pivotal VISION-DMD Study reveragen.com ↗ Primary endpoint Time to Stand (TTSTAND) velocity is met for vamorolone 6 mg/kg/day versus placebo (p=0.002)
2021-04-28	Santhera Pharmaceuticals	Results Santhera and ReveraGen Announce New 2.5-year Treatment Data with Vamorolone in Duchenne Muscular Dystrophy santhera.com ↗
2020-09-22	Santhera Pharmaceuticals	Results Santhera Announces Publication of Long-Term Clinical Data with Vamorolone in Patients with Duchenne Muscular Dystrophy santhera.com ↗ These 18- month treatment data extend previously published 24 -week treatment data, and show a reduction of corticosteroid-specific side effects and sustained efficacy with vamorolone including clinical improvement through the 18-month follow-up period.
2020-09-22	ReveraGen BioPharma, Inc.	Results Santhera Announces Publication of Long-Term Clinical Data with Vamorolone in Patients with Duchenne Muscular Dystrophy reveragen.com ↗ These 18- month treatment data extend previously published 24 -week treatment data, and show a reduction of corticosteroid-specific side effects and sustained efficacy with vamorolone including clinical improvement through the 18-month follow-up period.
2020-09-14	Santhera Pharmaceuticals	Results Santhera Announces Publication on Molecular Distinctions of Vamorolone Compared to Corticosteroids santhera.com ↗ It extends previous publications which characterized the unique pharmacological properties of vamorolone, a dissociative steroidal drug candidate that decreased muscle inflammation and improved muscle strength in mouse models of DMD [2-4].
2020-09-14	ReveraGen BioPharma, Inc.	Results Santhera Announces Publication on Molecular Distinctions of Vamorolone Compared to Corticosteroids reveragen.com ↗ Santhera Announces Publication on Molecular Distinctions of Vamorolone Compared to Corticosteroids
2019-10-21	Santhera Pharmaceuticals	Regulatory Vamorolone Designated Promising Innovative Medicine (PIM) for Treatment of Duchenne Muscular Dystrophy by the UK MHRA santhera.com ↗ Santhera Pharmaceuticals (SIX: SANN) announces that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has informed ReveraGen BioPharma about having designated vamorolone a s Promising Innovative Medicine (PIM) for the treatment of Duchenne muscular dystrophy (DMD).
2019-10-21	ReveraGen BioPharma, Inc.	Regulatory Vamorolone Designated Promising Innovative Medicine (PIM) for Treatment of Duchenne Muscular Dystrophy by the UK MHRA reveragen.com ↗ Santhera Pharmaceuticals (SIX: SANN) announces that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has informed ReveraGen BioPharma about having designated vamorolone a Promising Innovative Medicine (PIM) in the treatment of Duchenne muscular dystrophy (DMD).
2019-10-21	ReveraGen BioPharma, Inc.	Regulatory Vamorolone Designated Promising Innovative Medicine (PIM) for treatment in Duchenne muscular dystrophy reveragen.com ↗ We are delighted that MHRA has given PIM status to Vamorolone as a treatment for Duchenne Muscular Dystrophy.
2019-10-07	Santhera Pharmaceuticals	Results Santhera Announces Presentation by ReveraGen of Positive 18-Month Data with Vamorolone in Duchenne Muscular Dystrophy santhera.com ↗ These data demonstrate that vamorolone treatment results in persistently improved motor function in DMD patients, similar to that of corticosteroids.
2019-10-05	ReveraGen BioPharma, Inc.	Results Top-line data of 18-month vamorolone treatment of Duchenne muscular dystrophy patients shows continued improvement of symptoms with reduction in corticosteroid safety concerns reveragen.com ↗ A late-breaking presentation at the 24th International Annual Congress of the World Muscle Society (WMS) in Copenhagen, Denmark reported top-line data from 18-month treatment of Duchenne muscular dystrophy (DMD) patients (VBP15-LTE trial).
2019-08-28	ReveraGen BioPharma, Inc.	Results Vamorolone Treatment of Duchenne Muscular Dystrophy Patients Leads to Improvements in Motor Function reveragen.com ↗ The 6.0 mg/kg/day dose also showed significant improvements in time to run 10 meters and 6-minute walk test versus the 0.25 mg/kg/day dose group (p=0.006; p=0.002 respectively).
2019-08-27	Santhera Pharmaceuticals	Results Santhera Announces Publication by ReveraGen of Positive Phase IIa-Extension Study Results with Vamorolone in Patients with Duchenne Muscular Dystrophy santhera.com ↗ Data from 6 -month Phase IIa-extension study (VBP15 -003) published in Neurology [1] demonstrated dose-related improvement of muscle function in patients with DMD treated with vamorolone.
2018-10-03	ReveraGen BioPharma, Inc.	Results Vamorolone (VBP15) First-in-patient Studies in Duchenne Muscular Dystrophy Published reveragen.com ↗ The authors report that vamorolone was safe and well-tolerated through the highest dose tested (6.0 mg/kg/day, or about 9-times typical prednisone dose in DMD) and showed pharmacokinetics similar to prednisone.
2018-06-26	ReveraGen BioPharma, Inc.	Results Vamorolone (VBP15) Top Line Data Shows Improvements in Strength and Endurance in Boys with Duchenne Muscular Dystrophy reveragen.com ↗ The study showed dose-related improvements of multiple function tests of strength and endurance.
2017-03-30	ReveraGen BioPharma, Inc.	Regulatory ReveraGen BioPharma Receives FDA Fast Track Designation for Vamorolone for the Treatment of Duchenne Muscular Dystrophy reveragen.com ↗ ReveraGen BioPharma Inc, a privately held corporation, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for vamorolone (VBP15) for the treatment of patients with Duchenne muscular dystrophy.
2013-09-05	ReveraGen BioPharma, Inc.	Results September 2013: VBP15 drug shows early promise for treatment of Duchenne muscular dystrophy reveragen.com ↗ VBP15 drug shows early promise for treatment of Duchenne muscular dystrophy

All press releases naming this drug 116 releases

Date	Issuer	Release
Show all 116 releases opens the full record — a long page

Evidence & citations 15 cited values

Every value below carries the sentence it was read from. 15 sources stand behind the page.

Field	Value	Cited text
Known as	Vamorolone	ClinicalTrials.gov intervention name — accepted as the source's own label NCT05185622 ↗ 10 NCT02760277 ↗ NCT03863119 ↗ NCT06689527 ↗ NCT03439670 ↗ NCT04348890 ↗ NCT06649409 ↗ NCT06713135 ↗ NCT05166109 ↗ NCT02760264 ↗ NCT03038399 ↗
Known as	9,11-dehydro dexamethasone	ChEMBL registry synonym — accepted as the source's own label CHEMBL2348780 ↗
Known as	9,11-dehydrodexamethasone acetate	ChEMBL registry synonym — accepted as the source's own label CHEMBL2348780 ↗
Known as	Agamree	ChEMBL registry synonym — accepted as the source's own label CHEMBL2348780 ↗
Known as	Vamorolona	ChEMBL registry synonym — accepted as the source's own label CHEMBL2348780 ↗
Known as	Vamorolone acetate	ChEMBL registry synonym — accepted as the source's own label CHEMBL2348780 ↗
Known as	Vbp-15 free alcohol	ChEMBL registry synonym — accepted as the source's own label CHEMBL2348780 ↗
Known as	VBP15	ClinicalTrials.gov intervention name — accepted as the source's own label NCT02415439 ↗
Action	Activate	“Vamorolone is a dissociative agonist of the glucocorticoid receptor” PMID 38335499 ↗ Feb 2024 1 “Glucocorticoid receptor agonist” CHEMBL2348780 ↗
Action	Inhibit	“Mineralocorticoid receptor antagonist” CHEMBL2348780 ↗
Modality	Small molecule	“vamorolone, a novel dissociative steroidal anti-inflammatory drug” PMID 32434278 ↗ May 2020
Route	Oral	“Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.” NCT02415439 ↗
Target	CYP3A4	“The purpose of this study was to investigate how vamorolone affects the CYP3A4 enzyme in humans” NCT06689527 ↗
Target	NR3C1	“Glucocorticoid receptor agonist” CHEMBL2348780 ↗
Target	NR3C2	“Mineralocorticoid receptor antagonist” CHEMBL2348780 ↗