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Pregnanolone (ELTANOLONE)
Pregnanolone (generic name: ELTANOLONE) is a eltanolone drug. It is currently in Phase 2 development.
Eltanolone works by enhancing the activity of GABA, a neurotransmitter that helps to calm down neuronal activity.
Eltanolone, also known as pregnanolone, is a small molecule drug that targets the GABA-A receptor alpha-1/beta-2/gamma-2 subunits. It is a potent anesthetic agent that works by enhancing the inhibitory effects of GABA, a neurotransmitter that helps to calm down neuronal activity. Eltanolone is not FDA-approved for any indications, and its commercial status is unknown. As a potent anesthetic, it requires careful consideration of its potential side effects, including respiratory depression and sedation. Further research is needed to fully understand its safety and efficacy profile.
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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). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| 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 | ELTANOLONE |
|---|---|
| Drug class | eltanolone |
| Target | GABA-A receptor alpha-1/beta-2/gamma-2, GABA-A receptor; anion channel |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | Phase 2 |
Mechanism of action
Imagine your brain is like a busy city, with lots of different signals and activities happening all the time. GABA is like a traffic cop that helps to slow down the traffic and keep things calm. Eltanolone is like a special tool that helps the traffic cop do its job even better, by making it easier for GABA to calm down the activity in the brain.
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:
- Pregnanolone CI brief — competitive landscape report
- Pregnanolone updates RSS · CI watch RSS
Frequently asked questions about Pregnanolone
What is Pregnanolone?
How does Pregnanolone work?
What is the generic name of Pregnanolone?
What drug class is Pregnanolone in?
What development phase is Pregnanolone in?
What does Pregnanolone target?
Related
- Drug class: All eltanolone drugs
- Target: All drugs targeting GABA-A receptor alpha-1/beta-2/gamma-2, GABA-A receptor; anion channel
- Therapeutic area: All drugs in Neuroscience
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing