Drugs / Vamorolone
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
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Agamree | — | 2023-12-14 | europa.eu ↗ |
| Approved | US (FDA) | AGAMREE | — | 2023-10-26 | fda.gov ↗ |
Trials 11 · a red edge is where a trial was stopped
| 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| Phase 1/2 | NCT04348890 | Sep 2020 → Sep 2022 | ulcerative colitis | ReveraGen BioPharma, Inc. | Withdrawn | No outcome recorded |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 | ||||||
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT03439670 Comparator | Jun 2018 → Feb 2021 | Duchenne muscular dystrophy | ReveraGen BioPharma, Inc. | Completed | No outcome recorded |
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 NCT03439670 ↗ |
| 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 20241“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 ↗ |