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Lytgobi (futibatinib)
Lytgobi (futibatinib) is a small molecule drug developed by Taiho Oncology, targeting fibroblast growth factor receptor 2 (FGFR2) in intrahepatic cholangiocarcinoma. It was FDA-approved in 2022 for this indication. Lytgobi is a patented medication with no generic manufacturers available. Key safety considerations include the potential for adverse effects such as diarrhea, nausea, and fatigue. Lytgobi's commercial status is patented, with Taiho Oncology as the current owner.
At a glance
| Generic name | futibatinib |
|---|---|
| Sponsor | Taiho Oncology |
| Target | Fibroblast growth factor receptor 2 |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2022 |
Approved indications
- Intrahepatic cholangiocarcinoma
Common side effects
- Nail toxicity
- Musculoskeletal pain
- Constipation
- Diarrhea
- Fatigue
- Dry mouth
- Alopecia
- Stomatitis
- Abdominal pain
- Dry skin
- Arthralgia
- Dysgeusia
Serious adverse events
- Pyrexia
- Gastrointestinal hemorrhage
- Ascites
- Musculoskeletal pain
- Bile duct obstruction
- Retinal pigment epithelial detachment
Key clinical trials
- A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma (PHASE2)
- TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (PHASE2)
- Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy. (PHASE2,PHASE3)
- Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements
- Study of the CHK1 Inhibitor BBI-355, an ecDNA-directed Therapy (ecDTx), and the RNR Inhibitor BBI-825, in Subjects With Tumors With Oncogene Amplifications (PHASE1)
- European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors (PHASE1,PHASE2)
- Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma (PHASE2)
- Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lytgobi CI brief — competitive landscape report
- Lytgobi updates RSS · CI watch RSS
- Taiho Oncology portfolio CI