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Eplivanserin (SR46349)
Eplivanserin (SR46349) is a 5-HT2A receptor antagonist Small molecule drug developed by Sanofi. It is currently in Phase 3 development for Hypoactive sexual desire disorder (HSDD) in premenopausal women.
Eplivanserin is a selective serotonin 5-HT2A receptor antagonist that modulates serotonergic signaling to treat sexual dysfunction.
Eplivanserin is a selective serotonin 5-HT2A receptor antagonist that modulates serotonergic signaling to treat sexual dysfunction. Used for Hypoactive sexual desire disorder (HSDD) in premenopausal women.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Sanofi is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Eplivanserin (SR46349) |
|---|---|
| Sponsor | Sanofi |
| Drug class | 5-HT2A receptor antagonist |
| Target | 5-HT2A receptor |
| Modality | Small molecule |
| Therapeutic area | Sexual Health / Urology |
| Phase | Phase 3 |
Mechanism of action
The drug selectively blocks 5-HT2A receptors, which are involved in inhibiting sexual function. By antagonizing these receptors, eplivanserin enhances sexual arousal and function. This mechanism targets the central nervous system's serotonergic pathways that suppress sexual response.
Approved indications
- Hypoactive sexual desire disorder (HSDD) in premenopausal women
Common side effects
- Nausea
- Dizziness
- Headache
- Insomnia
Key clinical trials
- Efficacy and Safety of Eplivanserin 5mg/Day in Insomnia Characterized by Sleep Maintenance Difficulties (PHASE3)
- Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia (PHASE3)
- Efficacy and Safety of Eplivanserin 5mg/Day on Sleep Maintenance Insomnia (PHASE3)
- Efficacy and Safety of Eplivanserin Treatment for Sleep Maintenance Insomnia Followed by Optional Extension up to 1 Year (PHASE3)
- Comparison of Eplivanserin and Lormetazepam in the Treatment of Insomnia Characterized by Sleep Maintenance Difficulties (PHASE3)
- Efficacy and Safety of SR46349B in Patients With Sleep Disorders in Fibromyalgia (PHASE2)
- Single Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Eplivanserin in Children With Insomnia (PHASE1)
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:
- Eplivanserin (SR46349) CI brief — competitive landscape report
- Eplivanserin (SR46349) updates RSS · CI watch RSS
- Sanofi portfolio CI
Frequently asked questions about Eplivanserin (SR46349)
What is Eplivanserin (SR46349)?
How does Eplivanserin (SR46349) work?
What is Eplivanserin (SR46349) used for?
Who makes Eplivanserin (SR46349)?
What drug class is Eplivanserin (SR46349) in?
What development phase is Eplivanserin (SR46349) in?
What are the side effects of Eplivanserin (SR46349)?
What does Eplivanserin (SR46349) target?
Related
- Drug class: All 5-HT2A receptor antagonist drugs
- Target: All drugs targeting 5-HT2A receptor
- Manufacturer: Sanofi — full pipeline
- Therapeutic area: All drugs in Sexual Health / Urology
- Indication: Drugs for Hypoactive sexual desire disorder (HSDD) in premenopausal women
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing