Drugs / Allopregnanolone
Allopregnanolone
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT06263010 | Jan 2024 → Jul 2025 | Parkinson disease | Roberta Brinton | Completed | No outcome recorded |
| Phase 1 | NCT03748303 | Oct 2019 → Dec 2022 | Alzheimer disease | University of Arizona | Terminated | No outcome recorded |
| Phase 1 | NCT02221622 | Aug 2014 → Feb 2018 | Alzheimer disease, cognitive impairment with or without cerebellar ataxia | University of Southern California | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT04003285 | Sep 2026 → Jun 2027 expected | traumatic brain injury | VA Office of Research and Development | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07079761 | Aug 2025 → Apr 2027 expected | post-traumatic stress disorder | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04838301 | Aug 2023 → Nov 2026 expected | Alzheimer disease 2 | University of Arizona | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04468360 | Mar 2022 → Apr 2025 | post-traumatic stress disorder | Boston University | Terminated | No outcome recorded |
| Phase 2 | NCT02603926 | Oct 2015 → Dec 2016 | fragile X-associated tremor/ataxia syndrome | Randi J. Hagerman, MD | Completed | No outcome recorded |
| Phase 2 | NCT01673828 | Apr 2013 → May 2015 | post-traumatic epilepsy, traumatic brain injury | Michael A. Rogawski, MD, PhD | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT04015869 Comparator | Jul 2019 → Sep 2023 | alcohol-related disorders | Yale University | Completed | No outcome recorded |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Allopregnanolone | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04003285 ↗ |
| Known as | 3α,5α-tetrahydroprogesterone | “Allopregnanolone is a neurosteroid ( 3α,5α-tetrahydroprogesterone, 3α-hydroxy-5α-pregnan-20-one) and by-product of the metabolism of the hormone progesterone.” NCT06263010 ↗ |
| Known as | 3α-hydroxy-5α-pregnan-20-one | “Allopregnanolone is a neurosteroid ( 3α,5α-tetrahydroprogesterone, 3α-hydroxy-5α-pregnan-20-one) and by-product of the metabolism of the hormone progesterone.” NCT06263010 ↗ |
| Known as | Allo | “Allopregnanolone (Allo) with 6% USP Dexolve (sulfobutyl ether-beta-cyclodextrin sodium salt) in 0.9% saline for IV infusion will be provided by the University of California,...” NCT07079761 ↗2“PK-1 Good Manufacturing Practices (GMP) allopregnanolone (Allo) with Dexolve in 0.9% saline for infusion manufactured by the University of California, Davis” NCT04468360 ↗ “This is an open-label, pilot clinical trial of allopregnanolone (Allo) as a regenerative treatment for Parkinson's disease.” NCT06263010 ↗ |
| Known as | Product H (allopregnanolone intravenous solution, high dose) | “Product H (allopregnanolone intravenous solution, high dose)” NCT01673828 ↗ |
| Known as | Product L (allopregnanolone intravenous solution, low dose) | “Product L (allopregnanolone intravenous solution, low dose)” NCT01673828 ↗ |
| Action | Activate | “a potent positive allosteric modulator of the action of γ-aminobutyric acid at GABAA receptor” NCT02603926 ↗ |
| Modality | Small molecule | “Allopregnanolone is an endogenous neurosteroid with the potential to be a novel regenerative therapeutic for Alzheimer's disease (AD).” PMID 33344752 ↗ Dec 2020 |
| Route | Intravenous | “Allopregnanolone injection (intravenous solution) continuous infusion for 5 days” NCT01673828 ↗ |