Last reviewed · How we verify
GRAN®
GRAN®, marketed by EVIVE Biotechnology, is a small molecule indicated for chemotherapy-induced nausea and vomiting. The drug's key strength lies in its specific mechanism of action, which targets a unique pathway in the body, potentially offering a differentiated therapeutic profile. The primary risk to GRAN® is the expiration of its key composition patent in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | GRAN® |
|---|---|
| Also known as | Filgrastim |
| Sponsor | EVIVE Biotechnology |
| Target | 5-hydroxytryptamine receptor 3B, Multidrug and toxin extrusion protein 1, Solute carrier family 22 member 2 |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
- Chemotherapy-induced nausea and vomiting
- Post-Operative Nausea and Vomiting
- Prevention of Post-Operative Nausea and Vomiting
- Prevention of Radiation-Induced Nausea and Vomiting
Common side effects
- Menorrhagia
- Vomiting
Serious adverse events
- Discontinuation due to bleeding events (EINSTEIN Junior)
- Discontinuation due to bleeding events (UNIVERSE)
Key clinical trials
- Study to Compare the Efficacy and Safety of F-627 and GRAN® (PHASE3)
- Staccato® Granisetron Single Dose PK (PHASE1)
- Tick-borne Encephalitis and Borrelial Antibodies in Serum (NA)
- Granisetron 1 mg Tablets Under Fasting Conditions (PHASE1)
- Granisetron 1 mg Tablets, Non-fasting (PHASE1)
- Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 2 to 5 Years (PHASE1)
- Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years (PHASE1)
- An Investigation on the Effect of Age and BMI on the Pharmacokinetics of Transdermal Granisetron (PHASE1)
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 |