Drugs / AB-1009
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT07282847 | Apr 2026 → Sep 2028 expected | glycogen storage disease due to acid maltase deficiency, late-onset | AskBio Inc | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-01-15 | Belief BioMed (Beijing) Co., Ltd | Regulatory 专业赋能 共筑健康 | 信念医药热烈祝贺合作伙伴美国AskBio公司晚发性庞贝病基因疗法获批美国IND beliefbiomed.com ↗
2026年1月，拜耳集团（Bayer AG）全资拥有并独立运营的基因治疗子公司AskBio Inc.（AskBio）近期宣布，美国食品药品监督管理局（FDA）已接受其用于治疗晚发性庞贝病的腺相关病毒（AAV）基因治疗药物 AB-1009 的临床试验申请（IND）。 |
| 2026-01-08 | Bayer | Regulatory AskBio Announces FDA Acceptance of Investigational New Drug (IND) Application for AB-1009 Gene Therapy for Treatment of Late-Onset Pompe Disease (LOPD) bayer.com ↗
AskBio Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that the United States Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for AB-1009, an adeno-associated virus (AAV) gene therapy being developed for the treatment of late-onset Pompe disease (LOPD). |
| 2026-01-08 | AskBio Inc | Regulatory AskBio Announces FDA Acceptance of Investigational New Drug (IND) Application for AB-1009 Gene Therapy for Treatment of Late-Onset Pompe Disease (LOPD) askbio.com ↗
AskBio Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that the United States Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for AB-1009, an adeno-associated virus (AAV) gene therapy being developed for the treatment of late-onset Pompe disease (LOPD). |
All press releases naming this drug 5 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AB-1009 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07282847 ↗ |
| Route | Intravenous | “single intravenous infusion of AB-1009” NCT07282847 ↗ |