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saredutant (SR48968)
saredutant (SR48968) is a NK1 receptor antagonist Small molecule drug developed by Sanofi. It is currently in Phase 3 development for Chemotherapy-induced nausea and vomiting.
Saredutant is an antagonist of the neurokinin-1 (NK1) receptor.
Saredutant, also known as SR48968, is a small molecule that acts as a neurokinin 2 receptor antagonist. It has been studied in clinical trials for the treatment of depressive disorder, anxiety, and generalized anxiety.
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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). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway. -
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 | saredutant (SR48968) |
|---|---|
| Sponsor | Sanofi |
| Drug class | NK1 receptor antagonist |
| Target | NK1 receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
By blocking the NK1 receptor, saredutant is intended to prevent the action of substance P, a neurotransmitter involved in the transmission of pain signals. This mechanism is thought to be beneficial in the treatment of chemotherapy-induced nausea and vomiting.
Approved indications
- Chemotherapy-induced nausea and vomiting
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Fatigue
Key clinical trials
- An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Depression (PHASE3)
- An Eight-week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive Disorder (PHASE3)
- An Eight-week Study Evaluating the Efficacy of a 100mg Dose of Saredutant Once Daily, in Elderly Patients With Major Depressive Disorder (PHASE3)
- An Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Generalized Anxiety Disorder (PHASE3)
- An Eight-week Study of Saredutant and Escitalopram as Combination Treatment for Major Depressive Disorder (PHASE3)
- An Eight-week Study to Evaluate the Efficacy and Safety of 2 Doses of Saredutant in Patients With Generalized Anxiety Disorder (PHASE3)
- A 24-52-week Study to Evaluate the Long-term Efficacy and Safety of Saredutant in Patients With Depression (MAGENTA) (PHASE3)
- A Study Evaluating the Safety and Tolerability of Abrupt Discontinuation of Saredutant in Patients With Depression (PHASE3)
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:
- saredutant (SR48968) CI brief — competitive landscape report
- saredutant (SR48968) updates RSS · CI watch RSS
- Sanofi portfolio CI
Frequently asked questions about saredutant (SR48968)
What is saredutant (SR48968)?
How does saredutant (SR48968) work?
What is saredutant (SR48968) used for?
Who makes saredutant (SR48968)?
What drug class is saredutant (SR48968) in?
What development phase is saredutant (SR48968) in?
What are the side effects of saredutant (SR48968)?
What does saredutant (SR48968) target?
Related
- Drug class: All NK1 receptor antagonist drugs
- Target: All drugs targeting NK1 receptor
- Manufacturer: Sanofi — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Chemotherapy-induced nausea and vomiting
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing