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Allopregnanolone
Allopregnanolone is a Small molecule drug developed by University of Arizona. It is currently in Phase 2 development. Also known as: Allo, 3α,5α-tetrahydroprogesterone, 3α-hydroxy-5α-pregnan-20-one, Product L (allopregnanolone intravenous solution, low dose).
Allopregnanolone is a naturally occurring neurosteroid derived from progesterone, and it has been studied as a potential treatment for various conditions, including traumatic brain injury, posttraumatic epilepsy, depression, and menstrual migraine. As a medication, allopregnanolone is known as brexanolone and has been used to treat postpartum depression through intravenous injection.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Allopregnanolone |
|---|---|
| Also known as | Allo, 3α,5α-tetrahydroprogesterone, 3α-hydroxy-5α-pregnan-20-one, Product L (allopregnanolone intravenous solution, low dose), Product H (allopregnanolone intravenous solution, high dose) |
| Sponsor | University of Arizona |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- An Open-Label Extension Study to Evaluate the Safety and Tolerability of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 OLE Study) (PHASE2)
- A Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 Study) (PHASE2)
- Allopregnanolone in Chronic Complex Traumatic Brain Injury (PHASE2)
- Allopregnanolone Regenerative Therapeutic for Early Alzheimer's Disease: Intramuscular Study (PHASE1)
- Allopregnanolone as a Regenerative Treatment for Parkinson's Disease (PHASE1)
- Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease (PHASE2)
- Study on Allopregnanolone and Depression in Perimenopausal Women (PHASE4)
- Allopregnanolone (Zuranolone) in Post-stroke Depression (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Allopregnanolone CI brief — competitive landscape report
- Allopregnanolone updates RSS · CI watch RSS
- University of Arizona portfolio CI
Frequently asked questions about Allopregnanolone
What is Allopregnanolone?
Who makes Allopregnanolone?
Is Allopregnanolone also known as anything else?
What development phase is Allopregnanolone in?
Related
- Manufacturer: University of Arizona — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Allo, 3α,5α-tetrahydroprogesterone, 3α-hydroxy-5α-pregnan-20-one, Product L (allopregnanolone intravenous solution, low dose), Product H (allopregnanolone intravenous solution, high dose)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing