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Droleptan
Droleptan is a Small molecule drug developed by Clinique Saint Jean, France. It is currently in Phase 1 development for Intra-Operative Nausea and Vomiting, Post-Operative Nausea and Vomiting. Also known as: Sedation.
Droleptan is a small molecule serotonin 2a (5-HT2a) receptor antagonist. It is used as an antidopaminergic drug for its antiemetic and antipsychotic properties, as well as a rapid sedative in intensive-care treatment.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Droleptan |
|---|---|
| Also known as | Sedation |
| Sponsor | Clinique Saint Jean, France |
| Target | D(4) dopamine receptor, 5-hydroxytryptamine receptor 1A, 5-hydroxytryptamine receptor 2A |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
- Intra-Operative Nausea and Vomiting
- Post-Operative Nausea and Vomiting
Common side effects
- Anemia
- Diarrhea
- Fever
- Headache
- Hypertension
- Nausea
- Platelet count decreased
- Sinus tachycardia
- White blood cell decreased
- Alanine aminotransferase increased
- Anorexia
- Aspartate aminotransferase increased
Key clinical trials
- Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery (PONVACS) (Phase 3)
- Evaluation of the Efficacy of VR on Pain and Anxiety When Performing an Ultrasound-controlled Ankle Block. (NA)
- A Phase I/II Trial of T Cell Receptor Gene Therapy Targeting HPV-16 E7 for HPV-Associated Cancers (Phase 1)
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:
- Droleptan CI brief — competitive landscape report
- Droleptan updates RSS · CI watch RSS
- Clinique Saint Jean, France portfolio CI
Frequently asked questions about Droleptan
What is Droleptan?
What is Droleptan used for?
Who makes Droleptan?
Is Droleptan also known as anything else?
What development phase is Droleptan in?
What are the side effects of Droleptan?
What does Droleptan target?
Related
- Target: All drugs targeting D(4) dopamine receptor, 5-hydroxytryptamine receptor 1A, 5-hydroxytryptamine receptor 2A
- Manufacturer: Clinique Saint Jean, France — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Intra-Operative Nausea and Vomiting
- Indication: Drugs for Post-Operative Nausea and Vomiting
- Also known as: Sedation
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing