doxecitine
Small moleculeapprovedOrphan Drug FDA
Approved
Nov 3, 2025
Clinical trial activity
5 trials · 6 clinical orgs · 1 marketing orgs
Phase 1
2
Phase 2
2
Phase 3
0
Phase 4
0
Earliest trial started Feb 1, 1995 (NCT00002818)
Timeline
Indications
Studied for
- Acute Febrile Encephalopathy · Phase 2
- Bone Marrow Failure Disorders · Phase 1
- Cerebellum · Phase 1
- DNA, Mitochondrial · Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 1
- Dyskeratosis Congenita · Phase 1
- Leukemia · Phase 1
- Lung Diseases, Interstitial · Phase 1
- Lymphoma · Phase 1
- Metabolism · Phase 2
- Mitochondrial Diseases · Phase 2
- Mitochondrial Myopathies · Phase 2
- Multiple Myeloma · Phase 1
- Neutrophils · Phase 1
- Pulmonary Fibrosis · Phase 1
- Telomere · Phase 1
- Thymidine Kinase · Phase 2
Mechanism of action
- Deoxyadenosine kinaseSUBSTRATE
dak substrate
Combination products
kygevvi
with doxribtimine
Also known as doxecitine and doxribtimine
Approval history
- approvedPriority reviewNov 3, 2025
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06817590 | Phase 1 | Jun 30, 2025 | Harvard University |
| NCT06754098 | Phase 2 | Jan 1, 2025 | UCB, Universidad Complutense de Madrid |
| NCT04802707 | Phase 2 | Oct 18, 2021 | McGill University |
| NCT00002818 | Phase 1 | Feb 1, 1995 | National Cancer Institute (NCI), Virginia Commonwealth University |
| NCT06590493 | N/A | — | UCB |
Showing 5 of 5 trials
Page 1 / 1
Organizations
Research & Development (6)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| UCB | For profit | 2 | 1 | 2 | 2025 |
| Harvard University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| McGill University | Academic/Hospital | 1 | 1 | 1 | 2021 |
| National Cancer Institute (NCI) | Government | 1 | 0 | 1 | 1995 |
| Universidad Complutense de Madrid | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Virginia Commonwealth University | Academic/Hospital | 1 | 1 | 1 | 1995 |
6 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| UCB | For profit | NDA2 | Nov 3, 2025 |