drugset
Drugs / Resamirigene bilparvovec
last change Nov 2023 re-read 3 minutes ago

Resamirigene bilparvovec

also known as AT-001 (GENE THERAPY) · AT-132 · Resamirigen bilparvovec

Gene therapy (AAV / viral vector)

Developed for
X-linked myotubular myopathy
Investigated by
Astellas Gene Therapies

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Clinical hold US (FDA) — X-linked myotubular myopathy 2023-11-15

“The AT132 IND and ASPIRO trial are currently on clinical hold.” astellas.com ↗

Trials 1

today NCT03199469 · Ph 2/3
2018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2/3 NCT03199469 Aug 2017 → Sep 2021 overdue X-linked myotubular myopathy Astellas Gene Therapies Active not recruiting Met primary

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2023-11-15 Astellas Pharma Inc Results Astellas Announces Data from ASPIRO Study in X-linked Myotubular Myopathy Published in The Lancet Neurology astellas.com ↗

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as Resamirigene bilparvovec ClinicalTrials.gov intervention name — accepted as the source's own label NCT03199469 ↗
Known as AT-001 (GENE THERAPY) ChEMBL registry synonym — accepted as the source's own label CHEMBL4298181 ↗
Known as AT-132 ChEMBL registry synonym — accepted as the source's own label CHEMBL4298181 ↗
Known as Resamirigen bilparvovec ChEMBL registry synonym — accepted as the source's own label CHEMBL4298181 ↗
Modality Gene therapy (AAV / viral vector) “an AAV8-Delivered Gene Therapy” NCT03199469 ↗
Route Intravenous “Participants received a single dose of resamirigene bilparvovec delivered intravenously.” NCT03199469 ↗