diroximel
Trade name: Vumerity
Small moleculeapproved
Approved
Oct 29, 2019
Clinical trial activity
6 trials · 5 clinical orgs · 3 marketing orgs
Phase 1
2
Phase 2
3
Phase 3
3
Phase 4
0
Earliest trial started Dec 1, 2015 (NCT02634307)
Timeline
2010s
- Jan 1, 2015
Earliest Phase 3 Sponsor(trial)
- Oct 29, 2019
Biogen-IDEC — Earliest FDA Approval
- Oct 29, 2019
Biogen — Marketing Organization
- Oct 29, 2019
Biogen-IDEC — NDA Organization
2020s
- Jan 1, 2021
Earliest Phase 1 Sponsor(trial)
- Nov 12, 2025
Zydus Discovery DMCC — Marketing Organization
Indications
Approved for
Mechanism of action
- Keap1/Nrf2AGONIST
Keap1/Nrf2 agonist
- Kelch-like ECH-associated protein 1INHIBITOR
Kelch-like ECH-associated protein 1 inhibitor
Not fully elucidated. Activates the Nrf2 pathway involved in cellular response to oxidative stress, potentially through S-alkylation of the Nrf2 inhibitor Keap1
MMF is also a nicotinic acid receptor agonist in vitro.
Approval history
- approvedOct 29, 2019
Chemistry & pharmacology
Loading structure…
SMILES
COC(=O)/C=C/C(=O)OCCN1C(=O)CCC1=O- Mol. weight
- 255.23 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Prodrug
Sources
- ChEMBLCHEMBL3989944 ↗
Also known as
- alks 8700
- alks 8700
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06957808 | N/A | Jan 10, 2025 | Rosetrees Trust, University of London |
| NCT05127564 | Phase 1 | Jan 31, 2022 | Biogen |
| NCT05083923 | Phase 3 | Nov 19, 2021 | Biogen |
| NCT05181215 | Phase 1 | May 14, 2021 | Banner Life Sciences LLC |
| NCT03093324 | Phase 3 | Mar 15, 2017 | Alkermes |
| NCT02634307 | Phase 3 | Dec 1, 2015 | Alkermes |
Showing 6 of 6 trials
Page 1 / 1
Organizations
Research & Development (5)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Alkermes | For profit | 2 | 2 | 1 | 2015 |
| Biogen | For profit | 2 | 2 | 2 | 2021 |
| Banner Life Sciences LLC | For profit | 1 | 1 | 1 | 2021 |
| Rosetrees Trust | Academic/Hospital | 1 | 0 | 1 | 2025 |
| University of London | Academic/Hospital | 1 | 1 | 1 | 2025 |
5 organizations
Page 1 / 1
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Biogen | For profit | SYN | Oct 29, 2019 |
| Biogen | For profit | MKTG | Oct 29, 2019 |
| Biogen-IDEC | For profit | NDA | Oct 29, 2019 |
| Zydus Discovery DMCC | For profit | MKTG | Nov 12, 2025 |