Drug Type Small molecule drug |
Synonyms Vamorolone (USAN/INN), 8XP29XMB43, VB-15 + [3] |
Target |
Action agonists |
Mechanism GR agonists(Glucocorticoid receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (26 Oct 2023), |
RegulationOrphan Drug (United States), Rare Pediatric Disease (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Promising Innovative Medicine (United Kingdom), Priority Review (Canada), Paediatric investigation plan (European Union), Fast Track (United States) |
Molecular FormulaC22H28O4 |
InChIKeyZYTXTXAMMDTYDQ-DGEXFFLYSA-N |
CAS Registry13209-41-1 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D11000 | Vamorolone | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Muscular Dystrophy, Duchenne | United States | 26 Oct 2023 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Becker Muscular Dystrophy | Phase 2 | United States | 07 Jul 2022 | |
| Becker Muscular Dystrophy | Phase 2 | United States | 07 Jul 2022 | |
| Becker Muscular Dystrophy | Phase 2 | Italy | 07 Jul 2022 | |
| Becker Muscular Dystrophy | Phase 2 | Italy | 07 Jul 2022 | |
| Pediatric Ulcerative Colitis | Phase 2 | - | 01 Sep 2020 | |
| Cystic Fibrosis | Preclinical | United States | 25 May 2016 | |
| Multiple Sclerosis | Preclinical | United States | 25 May 2016 | |
| Inflammatory Bowel Diseases | Preclinical | United States | 04 May 2016 | |
| Rheumatoid Arthritis | Preclinical | United States | 22 Apr 2016 | |
| Asthma | Preclinical | United States | 10 Apr 2016 |
Phase 4 | 40 | okqmeszfra(prizdleclg) = wbmaqmcupq jlmrkcssdw (unyckkkopn ) View more | Positive | 08 Mar 2026 | |||
Phase 2 | 54 | (Treatment Group 1) | rntmslflkr = ewebhkfdmg dciwldqyzf (ozvteuhbtq, xkdgrulpad - xdqydntkca) View more | - | 24 Oct 2025 | ||
(Treatment Group 2) | rntmslflkr = jxgyqrwpze dciwldqyzf (ozvteuhbtq, wuwsxamakd - ubywzntxvc) View more | ||||||
Phase 1 | - | 30 | nizzpoerva(qhesnluyyc) = mtjkysruxl qfjgtcivvj (jqxhndetcb, 1.290309) View more | - | 11 Sep 2025 | ||
Phase 2 | 118 | vppdnyrqwy(makxuzugrw) = smqgaesuby cquptyvbkb (zoxgvlfasy ) View more | Positive | 16 Mar 2025 | |||
vppdnyrqwy(makxuzugrw) = gfexxhbixc cquptyvbkb (zoxgvlfasy ) View more | |||||||
Phase 2 | 54 | (7-<18 years CS-treated) | tlyyokdbje(cuqxjqjasu) = Dose-dependent increases in adverse events were seen across all age groups; none led to study discontinuation or death hrzszwqcst (vjbxzqyfsq ) View more | Positive | 16 Mar 2025 | ||
Not Applicable | 100 | cyaaulbdgy(elokirhopx) = xlhvdtsqfx ipvqodgkbn (jvtouoclag ) View more | Positive | 16 Mar 2025 | |||
Not Applicable | - | 30 | zklqdstrvk(qczebzlkal) = It demonstrated a statistically significant increase in the urinary sodium/potassium ratio in the vamorolone arm compared to placebo (p<0.0001) following a fludrocortisone challenge. bobnvnbube (bbikugwjfe ) | Positive | 01 Oct 2024 | ||
placebo | |||||||
Phase 2 | 121 | rljfdlftst(ogyotdeulv) = vkjlnicmwc ojedwuymqx (npthvffqnc, 0.0135) View more | Positive | 12 Mar 2024 | |||
rljfdlftst(ogyotdeulv) = jxrhxrvpoc ojedwuymqx (npthvffqnc, 0.0138) View more | |||||||
Phase 2 | 118 | Vamorolone 2 mg/kg/day | xmnhjwioza(nvwjltqavj) = tkmwhxztlb wipyrsfrcs (gujcywdzjw ) View more | Negative | 03 Mar 2024 | ||
Prednisone 0.75 mg/kg/day | xmnhjwioza(nvwjltqavj) = zthojaabey wipyrsfrcs (gujcywdzjw ) View more | ||||||
NCT03439670 (FDA) Manual | Phase 2 | 90 | Placebo | nfffccvojo(srnnrkxcao) = kxxpscmopf hhvoavjwth (oyytpbkmgd ) View more | Positive | 26 Oct 2023 | |
nfffccvojo(srnnrkxcao) = gswlkzezsa hhvoavjwth (oyytpbkmgd ) View more |





