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Kygevvi (DOXECITINE)
KYGEVVI incorporates pyrimidine nucleosides into skeletal muscle mitochondrial DNA, restoring mitochondrial DNA copy number.
At a glance
| Generic name | DOXECITINE |
|---|---|
| Sponsor | Ucb Inc |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
When administered, KYGEVVI facilitates the incorporation of deoxycytidine and deoxythymidine into the mitochondrial DNA of skeletal muscle cells. This process helps to restore the mitochondrial DNA copy number, which is beneficial in TK2d mutant mice.
Approved indications
- thymidine kinase 2 deficiency (TK2d)
Common side effects
- Diarrhea
- Abdominal pain (including abdominal pain upper)
- Vomiting
- Alanine aminotransferase increased (ALT)
- Aspartate aminotransferase increased (AST)
Key clinical trials
- A Retrospective Study of Subjects With Thymidine Kinase 2 Deficiency
- A RETROspective Study of Patients With TK2d
- An Open-Label Study of Continuation Treatment With Combination Pyrimidine Nucleosides in Patients With TK2 Deficiency (PHASE2)
- Doxecitine and Doxribtimine-Expanded Access
- Doxecitin and Doxribthymine in Adult Subjects With Thymidine Kinase 2 (TK2) Deficiency (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Kygevvi CI brief — competitive landscape report
- Kygevvi updates RSS · CI watch RSS
- Ucb Inc portfolio CI