cultured thymus tissue
Trade name: Rethymic
BiologicalapprovedOrphan Drug FDABreakthrough Therapy FDA
Approved
Oct 8, 2021
Clinical trial activity
2 trials · 4 clinical orgs · 1 marketing orgs
Phase 1
0
Phase 2
2
Phase 3
0
Phase 4
0
Earliest trial started Nov 1, 2001 (NCT00576407)
Timeline
2000s
- Jan 1, 2001
Earliest Phase 2 Sponsor(trial)
- Aug 15, 2003
Orphan Drug Designation
2020s
- Oct 8, 2021
Sumitomo Dainippon — Earliest FDA Approval
- Oct 8, 2021
Sumitomo Dainippon — NDA Secondary Org
- Oct 8, 2021
Sumitomo Dainippon — NDA Organization
Indications
Approved for
Studied for
Mechanism of action
- ThymocytesSupplementation
Thymocytes supplementation
Approval history
- approvedBreakthroughOct 8, 2021
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT00576836 | Phase 2 | Sep 2, 2004 | Duke University, Enzyvant Therapeutics GmbH, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) |
| NCT00576407 | Phase 2 | Nov 1, 2001 | Duke University, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) |
Showing 2 of 2 trials
Page 1 / 1
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Duke University | Academic/Hospital | 2 | 1 | 1 | 2001 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 2 | 0 | 1 | 2001 |
| National Institutes of Health (NIH) | Government | 2 | 0 | 1 | 2001 |
| Enzyvant Therapeutics GmbH | For profit | 1 | 1 | 1 | 2004 |
4 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Sumitomo Dainippon | For profit | NDA2 | Oct 8, 2021 |
| Sumitomo Dainippon | For profit | NDA | Oct 8, 2021 |