Drugs / AVALOTCAGENE ONTAPARVOVEC
last change Oct 2022 re-read 2 minutes ago

AVALOTCAGENE ONTAPARVOVEC

also known as DTX301 · KFB12DX3PF · scAAV8OTC

Gene therapy (AAV / viral vector) targets OTC via restoration

Developed for
ornithine carbamoyltransferase deficiency
Investigated by
Ultragenyx Pharmaceutical Inc

Trials 2 · a red edge is where a trial was stopped

20182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT02991144 Jul 2017 → Dec 2021 ornithine carbamoyltransferase deficiency Ultragenyx Pharmaceutical Inc Completed No outcome recorded
Phase 31 trial
Phase 3 NCT05345171 Oct 2022 → Sep 2027 expected ornithine carbamoyltransferase deficiency Ultragenyx Pharmaceutical Inc Active not recruiting No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 3 sources stand behind the page.

FieldValueCited text
Known as AVALOTCAGENE ONTAPARVOVEC ChEMBL registry synonym — accepted as the source's own label CHEMBL4650252
Known as DTX301 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05345171
Known as KFB12DX3PF ChEMBL registry synonym — accepted as the source's own label CHEMBL4650252
Known as scAAV8OTC ClinicalTrials.gov intervention name — accepted as the source's own label NCT02991144
Action Restore “improvement of ornithine transcarbamylase (OTC) function” NCT05345171
Modality Gene therapy (AAV / viral vector) “Adeno-Associated Virus (AAV) Serotype 8 (AAV8)-Mediated Gene Transfer of Human Ornithine Transcarbamylase (OTC)” NCT02991144
Route Intravenous “single peripheral IV infusion” NCT02991144
Target OTC “non-replicating, recombinant scAAV8 encoding human ornithine transcarbamylase (OTC)” NCT02991144