Drugs / AB-1005
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT07566429 | Jul 2026 → Dec 2028 expected | Parkinson disease | Bayer | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07215403 | Jul 2026 → Dec 2027 expected | Parkinson disease | AskBio Inc | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2025-12-09 | Bayer | Regulatory AskBio’s AB-1005 and AB-1002 Receive Pioneering Regenerative Medical Product Designation in Japan bayer.com ↗ |
| 2025-12-09 | AskBio Inc | Regulatory AskBio’s AB-1005 and AB-1002 Receive Pioneering Regenerative Medical Product Designation in Japan askbio.com ↗ |
| 2025-05-27 | Bayer | Results AskBio Announces Publication of Complete Results of Phase 1b Trial of AB-1005 Gene Therapy in Participants with Parkinson’s Disease in Movement Disorders bayer.com ↗
In addition to these data, which were first presented in April 2024 at the American Academy of Neurology Annual Meeting, the publication notes that non-motor assessments remained numerically stable throughout the 18-month follow-up in the mild and moderate cohorts. |
| 2025-05-27 | AskBio Inc | Results AskBio Announces Publication of Complete Results of Phase 1b Trial of AB-1005 Gene Therapy in Participants with Parkinson’s Disease in Movement Disorders askbio.com ↗
AB-1005 was well tolerated with no attributed serious adverse events in participants with mild or moderate Parkinson’s disease (PD) through 18 months post-gene transfer |
| 2025-02-19 | Bayer | Regulatory AskBio Receives FDA Regenerative Medicine Advanced Therapy designation for Parkinson’s disease investigational gene therapy bayer.com ↗
AskBio Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that investigational gene therapy AB-1005 for the treatment of Parkinson’s disease (PD) has been granted Regenerative Medicine Advanced Therapy (RMAT) designation from the United States Food and Drug Administration (FDA). |
| 2025-02-19 | AskBio Inc | Regulatory AskBio Receives FDA Regenerative Medicine Advanced Therapy designation for Parkinson’s disease investigational gene therapy askbio.com ↗
The FDA determined that AB-1005, an investigational gene therapy intended to slow disease progression and improve motor outcomes in patients with PD, met the criteria for RMAT designation. |
| 2024-07-11 | Bayer | Regulatory AskBio receives FDA Fast Track and MHRA Innovation Passport designations for AB-1005 investigational GDNF gene therapy for Parkinson’s disease bayer.com ↗
Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track Designation for AB-1005, which is being developed for moderate Parkinson’s disease. |
| 2024-07-11 | AskBio Inc | Regulatory AskBio receives FDA Fast Track and MHRA Innovation Passport designations for AB-1005 investigational GDNF gene therapy for Parkinson’s disease askbio.com ↗
AB-1005 has also been awarded the Innovation Passport, the United Kingdom Medicines and Healthcare products Regulatory Agency (UK MHRA) innovative medicine designation, for the treatment of Parkinson’s disease. |
| 2024-04-16 | Bayer | Results AskBio presents 18-month Phase Ib trial results of AB-1005 gene therapy for patients with Parkinson’s disease bayer.com ↗
The study met its primary objective, which was to evaluate the safety of a one-time bilateral delivery of AB-1005 directly to the putamen. |
| 2024-04-16 | AskBio Inc | Results AskBio presents 18-month Phase Ib trial results of AB-1005 gene therapy for patients with Parkinson’s disease askbio.com ↗
The study met its primary objective, which was to evaluate the safety of a one-time bilateral delivery of AB-1005 directly to the putamen. |
| 2024-01-31 | Hopstem Biotechnology Inc. | Results 2024【一月精选】领域最新进展 hopstem.com ↗
拜耳公司及其子公司Asklepios BioPharmaceutical近日宣布，他们正在研发的基因疗法AB-1005（AAV2-GDNF）在帕金森病的1b期临床试验中达到了主要终点，并在11名接受治疗的患者中显示出良好的安全性。 |
| 2024-01-04 | Bayer | Results AskBio Phase Ib trial of AB-1005 gene therapy in patients with Parkinson’s disease meets primary endpoint bayer.com ↗
No serious adverse events have been attributed to AB-1005, with continued clinical follow-up for up to 5 years post administration ongoing. |
| 2024-01-04 | AskBio Inc | Results AskBio Phase Ib trial of AB-1005 gene therapy in patients with Parkinson’s disease meets primary endpoint askbio.com ↗
The study met its primary objective, which was to evaluate the safety of a one-time bilateral delivery of AB-1005 directly to the putamen. |
| 2023-03-29 | AskBio Inc | Results AskBio to Present Phase 1b Results Investigating AB-1005 (formerly AAV2-GDNF) as Treatment for Parkinson’s Disease at AD/PD TM 2023 International Conference on Alzheimer’s and Parkinson’s Diseases askbio.com ↗
Preliminary data to be presented suggest that both the gene therapy and the neurosurgical administration are generally safe, well tolerated and associated with enhanced mean putaminal coverage and clinical improvements. |
All press releases naming this drug 20 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AB-1005 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07566429 ↗ |
| Known as | AAV2-GDNF | “AB-1005 (AAV2-GDNF gene therapy)” NCT07566429 ↗ |
| Route | Other | “bilateral intraputaminal delivery of AB-1005” NCT07215403 ↗ |