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Aprepitant+Tropisetron
Aprepitant+Tropisetron is a NK1 receptor antagonist + 5-HT3 receptor antagonist combination Small molecule drug developed by Sun Yat-sen University. It is currently in Phase 3 development for Chemotherapy-induced nausea and vomiting (CINV) prevention in patients receiving highly emetogenic chemotherapy.
Aprepitant blocks neurokinin-1 (NK1) receptors while tropisetron blocks 5-HT3 receptors, together preventing chemotherapy-induced nausea and vomiting through dual antiemetic pathways.
Aprepitant blocks neurokinin-1 (NK1) receptors while tropisetron blocks 5-HT3 receptors, together preventing chemotherapy-induced nausea and vomiting through dual antiemetic pathways. Used for Chemotherapy-induced nausea and vomiting (CINV) prevention in patients receiving highly emetogenic chemotherapy.
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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.
| 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 | Aprepitant+Tropisetron |
|---|---|
| Sponsor | Sun Yat-sen University |
| Drug class | NK1 receptor antagonist + 5-HT3 receptor antagonist combination |
| Target | NK1 receptor (aprepitant); 5-HT3 receptor (tropisetron) |
| Modality | Small molecule |
| Therapeutic area | Oncology / Supportive Care |
| Phase | Phase 3 |
Mechanism of action
Aprepitant is a selective antagonist of substance P/neurokinin-1 receptors in the chemoreceptor trigger zone and vomiting center, addressing delayed emesis. Tropisetron is a 5-HT3 receptor antagonist that blocks serotonin signaling in the chemoreceptor trigger zone, addressing acute emesis. The combination targets complementary pathways to provide comprehensive antiemetic coverage across multiple phases of chemotherapy-induced nausea and vomiting.
Approved indications
- Chemotherapy-induced nausea and vomiting (CINV) prevention in patients receiving highly emetogenic chemotherapy
Common side effects
- Headache
- Constipation
- Fatigue
- Diarrhea
Key clinical trials
- Electroacupuncture for Chemotherapy-Induced GI Symptom Clusters in Breast Cancer (PHASE3)
- Electroacupuncture for the Prevention of Chemotherapy-induced Nausea and Vomiting in Patients With Breast Cancer (PHASE3)
- Emesis Control Study in Non-Hodgkin Lymphoma Patients Receiving R-CHOP (NA)
- Incidence of Chemotherapy-Induced Nausea and Vomiting Associated With Docetaxel-Cyclophosphamide in Early Breast Cancer. (PHASE4)
- Aprepitant Without Steroid in Preventing Chemotherapy-induced Nausea and Vomiting in Patients With Colorectal Cancer (PHASE3)
- Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis (NA)
- A Korean Study of Efficacy and Safety of Aprepitant-based Triple Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapy (Non-doxorubicin Hydrochloride [Adriamycin] and Cyclophosphamide Regimens) (MK-0869-225) (KMEC) (PHASE4)
- Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031) (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:
- Aprepitant+Tropisetron CI brief — competitive landscape report
- Aprepitant+Tropisetron updates RSS · CI watch RSS
- Sun Yat-sen University portfolio CI
Frequently asked questions about Aprepitant+Tropisetron
What is Aprepitant+Tropisetron?
How does Aprepitant+Tropisetron work?
What is Aprepitant+Tropisetron used for?
Who makes Aprepitant+Tropisetron?
What drug class is Aprepitant+Tropisetron in?
What development phase is Aprepitant+Tropisetron in?
What are the side effects of Aprepitant+Tropisetron?
What does Aprepitant+Tropisetron target?
Related
- Drug class: All NK1 receptor antagonist + 5-HT3 receptor antagonist combination drugs
- Target: All drugs targeting NK1 receptor (aprepitant); 5-HT3 receptor (tropisetron)
- Manufacturer: Sun Yat-sen University — full pipeline
- Therapeutic area: All drugs in Oncology / Supportive Care
- Indication: Drugs for Chemotherapy-induced nausea and vomiting (CINV) prevention in patients receiving highly emetogenic chemotherapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing