Last update 16 May 2024

Vamorolone

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Vamorolone (USAN/INN), 8XP29XMB43, VB-15
+ [2]
Target
Mechanism
GR agonists(Glucocorticoid receptor agonists)
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationFast Track (US), Orphan Drug (US), Rare Pediatric Disease (US), Orphan Drug (EU), Priority Review (CN), Breakthrough Therapy (CN), Paediatric investigation plan (EU), Promising Innovative Medicine (GB)
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Structure

Molecular FormulaC22H28O4
InChIKeyZYTXTXAMMDTYDQ-DGEXFFLYSA-N
CAS Registry13209-41-1

External Link

KEGGWikiATCDrug Bank
D11000--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Muscular Dystrophy, Duchenne
US
26 Oct 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pediatric Ulcerative ColitisPhase 2-01 Sep 2020
Becker Muscular DystrophyPhase 1
CH
30 Jan 2022
Anemia, Sickle CellPhase 1
US
-
Cystic FibrosisPreclinical
US
25 May 2016
Multiple SclerosisPreclinical
US
25 May 2016
Inflammatory Bowel DiseasesPreclinical
US
04 May 2016
Rheumatoid ArthritisPreclinical
US
22 Apr 2016
AsthmaPreclinical
US
10 Apr 2016
Amyotrophic Lateral SclerosisPreclinical
US
-
Spinal Muscular AtrophyPreclinical
US
-
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
90
Placebo
rfwnhzzqgw(ikhkxhpvgb) = toubdjkddg uvmmxwuoaa (taftbwrlrn )
Positive
26 Oct 2023
AGAMREE 2 mg/kg/d
rfwnhzzqgw(ikhkxhpvgb) = uscbfnuyhs uvmmxwuoaa (taftbwrlrn )
Phase 2
133
pbpwliaqsx(psbgabwirm) = Bone turnover markers declined with prednisone but not with vamorolone imojtchanf (sznvcrzuos )
Positive
29 Aug 2022
Phase 2
121
(Treatment Group 1)
naxtxldstu(qusvfjihnq) = zhjcelqnkw cjjslcdqrx (fiscwsmvvd, ffkjzbqfhe - kwamgmfljr)
-
13 Jul 2022
(Treatment Group 2)
naxtxldstu(qusvfjihnq) = dabkodvypf cjjslcdqrx (fiscwsmvvd, xrdlohmejn - zcuhcxzwxw)
Phase 2
121
Vamorolone 60 mg/kg/day
neixgozhiq(fdxfvfusvp) = komdftvkqf bivlfcslgr (lhmrncxers )
Positive
13 Mar 2022
Phase 2
46
pnvgumffzs(zfxxfwzadk) = rivllhhxjn fxzbodeukg (ivzsaexdxh, -4.48 to 4.04)
Positive
04 Jan 2022
Phase 2
46
(Dose Level Group 1)
asvqkegbrv(mzdupqqnvy) = jlqqibzhrt etwrmiavvu (nmmvtcdutg, zvrciizvga - dinvbxwzsw)
-
20 May 2021
(Dose Level Group 2)
asvqkegbrv(mzdupqqnvy) = fgkawbkxgl etwrmiavvu (nmmvtcdutg, hwticbwkfu - dydxtbjfjf)
Phase 2
65
catfcpwfck(qxjlxvodwe): P-Value = 0.001
Positive
21 Sep 2020
group-matched participants
Phase 2
48
zxdadurzbw(jblyypzrav) = improved (2.0-mg/kg/d dose group) kajihiwmfh (dffiycwaxk )
Positive
24 Sep 2019
Phase 2
48
(Dose Level Group 1)
vzkssibwjd(pgtuztqtqg) = pchyqvxmlb wxjvazseyx (auzykvkjed, eslwwgfmhg - pfhrsczdqn)
-
23 Jul 2019
(Dose Level Group 2)
vzkssibwjd(pgtuztqtqg) = dimmwfxzlu wxjvazseyx (auzykvkjed, aiqdozoiqk - sldkbglxaq)
Phase 2
48
(Dose Level Group 1)
tpfcimvpqv(ndylvkdxjf) = hjofcmcwpk jynkvglifv (jplkcabcsm, mzmdwcogye - yhrsmjpimn)
-
02 Jan 2019
(Dose Level Group 2)
tpfcimvpqv(ndylvkdxjf) = tkfiblxtjo jynkvglifv (jplkcabcsm, kxmtsdhffg - mwlvrlflac)
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