Data updated: May 26, 2026
LYTGOBI (futibatinib)
Trial Activity: Growth 8 active trials
Orphan Drug Breakthrough Therapy Priority Review Accelerated Approval Fast Track
Oncology
Approved 2022-09-30
Development Insights
Taiho Oncology, Inc. conducting 7 trials (47%)
51 indications explored (Broad Platform)
→ locally advanced unresectable or metastatic solid tumors including esophageal cancer (1 trials)
→ esophageal adenocarcinoma (1 trials)
→ esophageal squamous cell cancer (1 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
3
Years on Market
Details
- Status
- Prescription
- First Approved
- 2022-09-30
- Patent Cliff
- 2039
- Routes
- ORAL
- Dosage Forms
- TABLET
LYTGOBI Approval History
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2022 to 2025
What LYTGOBI Treats
1 FDA approvalsOriginally approved for its first indication in 2022 .
- Other (1)
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Clinical Trial Registry
16 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05945823 | TAS-120-206 | Ph 2 | active not recruiting | Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors |
| NCT06506955 | TAS120-404 | Ph 2, Ph 3 | enrolling by invitation | Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy. |
| NCT02693535 TAPUR | Pro00014171 | Ph 2 | recruiting | 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 |
| NCT05036681 results posted | 2020-0776 NCI-2021-09418 | Ph 2 | terminated | A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma |
| NCT05827614 POTENTIATE | BBI-355-101 | Ph 1 | active not recruiting | 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 |
| NCT02813135 ESMART | 2016-000133-40 2016/2396, 2024-514791-40-00 | Ph 1, Ph 2 | recruiting | European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors |
| NCT04601857 results posted | TAS-120-203 2020-000945-15 | Ph 2 | terminated | Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma |
| NCT06263153 | OSU-23329 NCI-2024-00002 | Ph 2 | recruiting | Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy |
| NCT04828486 results posted | MC200402 NCI-2021-02444, 20-007235 | Ph 2 | completed | Futibatinib and Pembrolizumab for Treatment of Advanced or Metastatic FGF19 Positive BCLC Stage A, B, or C Liver Cancer |
| NCT04024436 results posted | FOENIX-MBC2 TAS-120-201 2019-001164-30 | Ph 2 | terminated | A Study of TAS-120 in Patients With Metastatic Breast Cancer |
| NCT04189445 results posted | TAS-120-202 2019-004084-49 | Ph 2 | terminated | Futibatinib in Patients With Specific FGFR Aberrations |
| NCT05615818 SAFIR-ABC10 | UC-GMP-2201 - PRODIGE 78 2022-000190-19, 2022-502403-30-00 | Ph 3 | recruiting | Personalized Medicine for Advanced Biliary Cancer Patients |
| NCT02052778 results posted | TPU-TAS-120-101 2013-004810-16 | Ph 1, Ph 2 | completed | A Study of TAS-120 in Patients With Advanced Solid Tumors |
| NCT04093362 FOENIX-CCA3 results posted | TAS-120-301 2019-004630-42 | Ph 3 | terminated | Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements |
| NCT03767075 BoB | VHIO17002 2017-005108-89 | Ph 2 | recruiting | A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets) |
| NCT07594548 | NU 25I08 NCI-2026-03370, STU00225647 | Ph 1 | not yet recruiting | Futibatinib With Paclitaxel and Ramucirumab for the Treatment of Locally Advanced or Unresectable Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LYTGOBI FDA Label Details
View full patent landscape →
3 OB patents · 3 families ·
107 international docs across 26 countries
LYTGOBI Patents & Exclusivity
Latest Patent: Nov 2039
Exclusivity: Sep 2029
Patents (3 active)
Exclusivity
NCE
Until Sep 2027
ODE-410
Until Sep 2029
NCE
Until Sep 2027
ODE*
Until Sep 2029
NCE
Until Sep 2027
ODE-410
Until Sep 2029
NCE
Until Sep 2027
ODE*
Until Sep 2029
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for LYTGOBI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 12 active patents
Trial Analysis
- • 15 total trials
- • Stage: Growth
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment