Drugs / doxribtimine

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Kygevvi 2026-03-26 europa.eu
Approved US (FDA) KYGEVVI 2025-11-03 fda.gov

Trials 3 · a red edge is where a trial was stopped

today
US approved 2025
EU approved 2026
NCT06754098 · Ph 2 NCT03845712 · Ph 2
20202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT06754098 Jan 2025 → Jan 2027 expected inborn mitochondrial myopathy, mitochondrial DNA depletion syndrome, myopathic form Cristina Domínguez González Recruiting No outcome recorded
Phase 2 NCT03845712 Jul 2019 → Jul 2026 overdue mitochondrial DNA depletion syndrome, myopathic form UCB BIOSCIENCES, Inc. Active not recruiting No outcome recorded
Phase not stated1 trial
NCT06590493 mitochondrial DNA depletion syndrome, myopathic form UCB BIOSCIENCES, Inc. Available No outcome recorded

Press releases naming this drug 6 releases

DateIssuerRelease
2026-06-17 UCB Pharma UCB Announces Publication of Data in Brain Communications Demonstrating Positive Impact of KYGEVVI[®]▼ (doxecitine and doxribtimine) in Patients with Thymidine Kinase 2 Deficiency (TK2d) ucb.com
2026-03-31 UCB Pharma European Commission approves KYGEVVI[®]▼ (doxecitine and doxribtimine) as first and only treatment for Thymidine Kinase 2 Deficiency (TK2d) ucb.com
2026-01-30 UCB Pharma KYGEVVI[®] (doxecitine and doxribtimine) recommended for approval in the European Union as treatment for Thymidine Kinase 2 Deficiency (TK2d) ucb.com
2025-11-03 UCB Pharma U.S. FDA approves KYGEVVI[™] (doxecitine and doxribtimine), the first and only treatment for adults and children living with thymidine kinase 2 deficiency (TK2d) ucb.com
2025-10-13 UCB Pharma Results published in Neurology highlight a 95% reduction in risk of death with pyrimidine nucleos(t)ide therapy in patients with thymidine kinase 2 deficiency (TK2d) ucb.com
2025-03-19 UCB Pharma New data on investigational therapy for thymidine kinase 2 deficiency presented at Muscular Dystrophy Association (MDA) 2025 Conference ucb.com

Evidence & citations 13 cited values

Every value below carries the sentence it was read from. 4 sources stand behind the page.

FieldValueCited text
Known as Doxribtimine ClinicalTrials.gov intervention name — accepted as the source's own label NCT06754098
2

NCT06590493

NCT03845712

Known as 2'-deoxythymidine ChEMBL registry synonym — accepted as the source's own label CHEMBL52609
Known as Deoxyribothymidine ChEMBL registry synonym — accepted as the source's own label CHEMBL52609
Known as Doxribtimine component of mt-1621 2'-deoxythymidine ChEMBL registry synonym — accepted as the source's own label CHEMBL52609
Known as MT1621 (dT) ChEMBL registry synonym — accepted as the source's own label CHEMBL52609
Known as NSC-21548 ChEMBL registry synonym — accepted as the source's own label CHEMBL52609
Known as Thymidine ChEMBL registry synonym — accepted as the source's own label CHEMBL52609
Known as Thymidinedeoxyriboside ChEMBL registry synonym — accepted as the source's own label CHEMBL52609
Known as Thymine-2-desoxyriboside ChEMBL registry synonym — accepted as the source's own label CHEMBL52609
Known as Zidovudine related compound d ChEMBL registry synonym — accepted as the source's own label CHEMBL52609
Known as Zidovudine related compound d rs ChEMBL registry synonym — accepted as the source's own label CHEMBL52609
Modality Small molecule “Combination Pyrimidine Nucleosides” NCT03845712
Route Oral “Doxecitine and doxribtimine is administered orally” NCT03845712