doxribtimine

Small moleculeapprovedOrphan Drug FDA

Approved

Nov 3, 2025

Clinical trial activity

2 trials · 2 clinical orgs · 1 marketing orgs

Phase 1
0
Phase 2
1
Phase 3
0
Phase 4
0

Earliest trial started Jan 1, 2025 (NCT06754098)

Timeline

2010s

  1. Jul 7, 2016

    Orphan Drug Designation

2020s

  1. Jan 1, 2025

    Earliest Phase 2 Sponsor(trial)

  2. Nov 3, 2025

    Earliest FDA Approval

  3. Nov 3, 2025

    UCB — NDA Secondary Org

Indications

Mechanism of action

  • thymidineSupplementation

    thymidine supplementation

Combination products

  • kygevvi

    with doxecitine

    Also known as doxecitine and doxribtimine

Approval history

  • approvedPriority reviewNov 3, 2025

Chemistry & pharmacology

Loading structure…

SMILES

Cc1cn([C@H]2C[C@H](O)[C@@H](CO)O2)c(=O)[nH]c1=O
Mol. weight
242.23 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06754098Phase 2Jan 1, 2025UCB, Universidad Complutense de Madrid
NCT06590493N/AUCB
Showing 2 of 2 trials
Page 1 / 1

Organizations

Research & Development (2)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
UCBFor profit2122025
Universidad Complutense de MadridAcademic/Hospital1112025
2 organizations
Page 1 / 1

Marketing (1)

OrganizationOrg typeRelationshipDate
UCBFor profitNDA2Nov 3, 2025