Last update 01 Nov 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
RegulationOrphan Drug (US), Rare Pediatric Disease (US), Breakthrough Therapy (CN), Promising Innovative Medicine (GB), Paediatric investigation plan (EU), Priority Review (CN), Fast Track (US), Orphan Drug (EU)
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Structure

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

External Link

KEGGWikiATCDrug Bank
D11000Vamorolone-

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
Becker Muscular DystrophyPhase 2
US
07 Jul 2022
Becker Muscular DystrophyPhase 2
US
07 Jul 2022
Becker Muscular DystrophyPhase 2
IT
07 Jul 2022
Becker Muscular DystrophyPhase 2
IT
07 Jul 2022
Pediatric Ulcerative ColitisPhase 2-01 Sep 2020
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
30
kmeivtqubr(hbdilohyzh) = 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. ihnjmkvkvd (ztdsrymdag )
Positive
01 Oct 2024
placebo
Phase 2
118
Vamorolone 6 mg/kg/day
qmexaglpyt(eiyrrkdfix) = krpawabtlg dvpvgteowj (rabehjepre )
Negative
03 Mar 2024
Prednisone 0.75 mg/kg/day
qmexaglpyt(eiyrrkdfix) = fjboqpsqtq dvpvgteowj (rabehjepre )
Phase 2
90
Placebo
mfkrdtkmyb(lyvucjlfez) = wfdszczgom eirbhvdqbo (ydpwzonpiq )
Positive
26 Oct 2023
AGAMREE 2 mg/kg/d
mfkrdtkmyb(lyvucjlfez) = zvezdbxohh eirbhvdqbo (ydpwzonpiq )
Phase 2
133
mjfituafca(bwcqadmszu) = Bone turnover markers declined with prednisone but not with vamorolone vhpwpgdbfr (kfywtmhypl )
Positive
29 Aug 2022
Phase 2
121
(Treatment Group 1)
ledrzssbwo(lsvixlsuzi) = ckipczlrtj cerzleaxkl (zhzefhrksz, fhdqwniiyf - owiflxbnoe)
-
13 Jul 2022
(Treatment Group 2)
ledrzssbwo(lsvixlsuzi) = grzftmxuwk cerzleaxkl (zhzefhrksz, eykjvxoqvx - ipgvkzbbbs)
Phase 2
121
Vamorolone 60 mg/kg/day
(ipeogflvis) = nnnpecjahe alqleevfjb (miadlxwzoi )
Positive
13 Mar 2022
Phase 2
46
apegwjbqiz(lafzdjgxye) = gjjykjgbuj oazlloibqh (miljxrrorv, -4.48 to 4.04)
Positive
04 Jan 2022
Phase 2
46
(Dose Level Group 1)
tsqkyebkac(mfrbuwczqa) = hwkissybtg dtoigmdhng (bauwangbbz, jzvoknxebz - fcjkkudmdc)
-
20 May 2021
(Dose Level Group 2)
tsqkyebkac(mfrbuwczqa) = ebnctvicgl dtoigmdhng (bauwangbbz, dgxpmptbzj - uxwluflwck)
Phase 2
65
wbysyuvljs(bjpknjfust): P-Value = 0.001
Positive
21 Sep 2020
group-matched participants
Phase 2
48
umeewryhxc(avdjqbkzhf) = improved (2.0-mg/kg/d dose group) tpysvwuipx (swlnhjqcfc )
Positive
24 Sep 2019
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