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Granisetron plus dexamethasone
Granisetron plus dexamethasone is a Small molecule drug developed by Shanghai Children's Medical Center. It is currently in Phase 1 development.
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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 | Granisetron plus dexamethasone |
|---|---|
| Sponsor | Shanghai Children's Medical Center |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer (PHASE3)
- A Prospective, Multicenter, Study of APF530 (Granisetron) SC for Prevention of CINV in Patients Receiving HEC (PHASE3)
- Granisetron Combined With Dexamethasone or Metoclopramide for PONV Prevention After Laparoscopic Cholecystectomy (PHASE4)
- BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron (PHASE4)
- Antiemetic Therapy With or Without Olanzapine in Preventing Chemotherapy-Induced Nausea and Vomiting in Patients With Cancer Receiving Highly Emetogenic Chemotherapy (PHASE3)
- Emesis Control Study in Non-Hodgkin Lymphoma Patients Receiving R-CHOP (NA)
- The Effect of Music Therapy on Nausea, Vomiting and Anxiety Levels in Children (NA)
- Aprepitant Plus Granisetron and Dexamethasone for the Prevention of Vomiting in Patients With HAIC Therapy for HCC (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:
- Granisetron plus dexamethasone CI brief — competitive landscape report
- Granisetron plus dexamethasone updates RSS · CI watch RSS
- Shanghai Children's Medical Center portfolio CI
Frequently asked questions about Granisetron plus dexamethasone
What is Granisetron plus dexamethasone?
Who makes Granisetron plus dexamethasone?
What development phase is Granisetron plus dexamethasone in?
Related
- Manufacturer: Shanghai Children's Medical Center — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing