fecal microbiota spores, live-brpk
Trade name: Vowst
Cell therapyapprovedOrphan Drug FDABreakthrough Therapy FDA
Approved
Apr 26, 2023
Clinical trial activity
0 trials · 0 clinical orgs · 1 marketing orgs
Phase 1
0
Phase 2
0
Phase 3
0
Phase 4
0
Timeline
2010s
- Aug 19, 2015
Orphan Drug Designation
2020s
- Apr 26, 2023
Seres Therapeutics — Earliest FDA Approval
- Apr 26, 2023
Seres Therapeutics — NDA Secondary Org
- Apr 26, 2023
Seres Therapeutics — NDA Organization
Indications
Approved for
Mechanism of action
- microbiotaTissue restoration
microbiota tissue restoration
Approval history
- approvedBreakthroughApr 26, 2023
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Organizations
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Seres Therapeutics | For profit | NDA2 | Apr 26, 2023 |
| Seres Therapeutics | For profit | NDA | Apr 26, 2023 |