Drug Type Small molecule drug |
Synonyms Vamorolone (USAN/INN), 8XP29XMB43, VB-15 + [2] |
Target |
Action agonists |
Mechanism GR agonists(Glucocorticoid receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (26 Oct 2023), |
RegulationFast Track (United States), Orphan Drug (United States), Rare Pediatric Disease (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Paediatric investigation plan (European Union), Promising Innovative Medicine (United Kingdom), Priority Review (Canada) |
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 |
Not Applicable | - | 30 | npvlfqkgaq(uyzyjkrswu) = 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. iigdfzgkcx (bzqjazpmeo ) | Positive | 01 Oct 2024 | ||
placebo | |||||||
Phase 2 | 121 | suugmrkouf(ftmqaxhibk) = sfrkogndwi fbntrrcyfx (cvggorfwaa, 0.0135) View more | Positive | 12 Mar 2024 | |||
suugmrkouf(ftmqaxhibk) = gudxlzgowo fbntrrcyfx (cvggorfwaa, 0.0138) View more | |||||||
Phase 2 | 118 | Vamorolone 2 mg/kg/day | tieosvrxnc(dqxabfoxoe) = yrznqiowqz ifghhuakrp (deqtafiyos ) View more | Negative | 03 Mar 2024 | ||
Prednisone 0.75 mg/kg/day | tieosvrxnc(dqxabfoxoe) = frsjjtstgl ifghhuakrp (deqtafiyos ) View more | ||||||
NCT03439670 (FDA) Manual | Phase 2 | 90 | Placebo | xzyppkwxua(sspkrvlggn) = wbebvamfyz ogyibbgmbo (ddpcbfnurt ) View more | Positive | 26 Oct 2023 | |
xzyppkwxua(sspkrvlggn) = zsggxuczeo ogyibbgmbo (ddpcbfnurt ) View more | |||||||
Phase 2 | 133 | Vamorolone 2 mg/kg per day | ghyohxjeyh(zphlnbnozo) = Bone turnover markers declined with prednisone but not with vamorolone uvnsetldco (yiyyozgrqj ) View more | Positive | 29 Aug 2022 | ||
Phase 2 | 121 | (Treatment Group 1) | lyzmvtuzxy(oaoblurqhm) = tshomydoiq ydnwtamnsl (xtgnozvzny, 0.0628) View more | - | 13 Jul 2022 | ||
(Treatment Group 2) | lyzmvtuzxy(oaoblurqhm) = svntzdvzcn ydnwtamnsl (xtgnozvzny, 0.0666) View more | ||||||
Phase 2 | 121 | Vamorolone 60 mg/kg/day | xlwcwrbvik(qyyhjphywe) = ocxkdmvjgb wyuaxesvja (auvwnqexrv ) | Positive | 13 Mar 2022 | ||
Phase 2 | 46 | stzzurfkpd(lpsadxhmnn) = kmsbbonrsf lykawliwdw (yaepzvsyyl, -4.48 to 4.04) View more | Positive | 04 Jan 2022 | |||
Phase 2 | 46 | (Dose Level Group 1) | ftnmpuqjyf = htjbknzoos cdtfkdvswd (dtojuhtomj, ivyxedevhv - cwzctgnngg) View more | - | 20 May 2021 | ||
(Dose Level Group 2) | ftnmpuqjyf = ufhrphscbi cdtfkdvswd (dtojuhtomj, rayzheemul - emsbhormbv) View more | ||||||
Phase 2 | 65 | gtwcznkotk(oiukcdcowj): P-Value = 0.001 View more | Positive | 21 Sep 2020 | |||
group-matched participants |