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Sivopixant
Sivopixant is a Small molecule drug developed by Shionogi Apnimed Sleep Science. It is currently in Phase 2 development.
Sivopixant is a medication being studied for the treatment of Chronic Cough and Sleep Apnea in clinical trials. The exact mechanism of action of Sivopixant is currently unknown.
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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 | Sivopixant |
|---|---|
| Sponsor | Shionogi Apnimed Sleep Science |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Safety and Efficacy Study of Sivopixant, Acetazolamide and SASS-001 in Sleep Apnea (PHASE2)
- Evaluation of S-600918 in Adults With Refractory Chronic Cough (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:
- Sivopixant CI brief — competitive landscape report
- Sivopixant updates RSS · CI watch RSS
- Shionogi Apnimed Sleep Science portfolio CI
Frequently asked questions about Sivopixant
What is Sivopixant?
Who makes Sivopixant?
What development phase is Sivopixant in?
Related
- Manufacturer: Shionogi Apnimed Sleep Science — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing