Lytgobi

(Futibatinib)

Phase 3Small molecule

Lytgobi is a small molecule that works as a FGFR Inhibitor.[2] It is being investigated across 8 indications, with its most advanced program in Phase 3.[1]

Lytgobi is one of 176 small molecule programs targeting Biliary Tract Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

175

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Biliary Tract CancerRecruiting

Pediatric CancerRecruiting

Advanced/metastatic CancerActive, not recruiting

Biliary Tract Cancer (BTC)Not yet recruiting

Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal CancerActive, not recruiting

CancerRecruiting

Biliary CancerRecruiting

Bladder CancerRecruiting

Biliary Tract CancerPhase 3

Recruiting

Pediatric CancerPreclinical

Recruiting

Advanced/metastatic CancerPreclinical

Active, not recruiting

Biliary Tract Cancer (BTC)Phase 3

Not yet recruiting

Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal CancerPhase 2

Active, not recruiting

CancerPhase 2

Recruiting

Biliary CancerPhase 3

Recruiting

Bladder CancerPhase 2

Recruiting

Competition

Competitive Landscape

118 competitors in Bladder Cancer

#DrugCompanyPhaseTrials

Gemzar

Johnson & Johnson

Phase 3

52 2

Keytruda

Merck & Co.

Phase 3

27 3

Opdivo

Bristol-Myers Squibb

Phase 3

20 4

Platinol

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Phase 3

57 5

Tecentriq

Roche

Phase 3

16 6

Imfinzi

AstraZeneca

Phase 3

16 7

Trexall

Jazz Pharmaceuticals

Phase 3

12 8

Padcev

Pfizer

Phase 3

8 9

Imjudo

AstraZeneca

Phase 3

8 10

Gemzar

GGynecologic Oncology Group

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Cancer

NCT03767075

Phase 2Recruiting

Bladder Cancer

NCT06263153

Q1 2027

Phase 2Active, not recruiting

Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer

NCT05945823

Q2 2027

PreclinicalActive, not recruiting

Advanced/metastatic Cancer

NCT06506955

Q2 2028

Phase 3Recruiting

Biliary Cancer

NCT05615818

Clinical

Trials by Indication[1]

Bladder Cancer1 trial

Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy

Recruiting·YYuanquan Yang·Phase 2·NCT06263153·24 enrolled

Endometrial Carcinoma1 trial

A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT05036681·9 enrolled

Patients With Advanced Solid Tumors1 trial

A Study of TAS-120 in Patients With Advanced Solid Tumors

Completed· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 1/2·NCT02052778·407 enrolled

Cholangiocarcinoma1 trial

Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements

Terminated· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 3·NCT04093362·10 enrolled

Biliary Cancer1 trial

Personalized Medicine for Advanced Biliary Cancer Patients

Recruiting·UUNICANCER·Phase 3·NCT05615818·800 enrolled

12 more indications

Liver Cancer1 trial

Futibatinib and Pembrolizumab for Treatment of Advanced or Metastatic FGF19 Positive BCLC Stage A, B, or C Liver Cancer

Completed·MMayo Clinic·Phase 2·NCT04828486·14 enrolled

Breast Cancer1 trial

A Study of TAS-120 in Patients With Metastatic Breast Cancer

Terminated· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 2·NCT04024436·64 enrolled

Urothelial Carcinoma1 trial

Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma

Terminated· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 2·NCT04601857·43 enrolled

Cancer1 trial

A Modular Multi-Basket Trial to Improve Personalized Medicine in Cancer Patients (Basket of Baskets)

Recruiting·VVall d'Hebron Institute of Oncology·Phase 2·NCT03767075·1,000 enrolled

Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer1 trial

A Phase 2 Study of Futibatinib in Combination With PD-1 Antibody-based Standard of Care Therapy in Patients With Solid Tumors.

Active, not recruiting· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 2·NCT05945823·53 enrolled

Lymphoma, Non-Hodgkin1 trial

Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Recruiting·AAmerican Society of Clinical Oncology·Phase 2·NCT02693535·4,200 enrolled

Triple Negative Breast Cancer (TNBC)1 trial

An Open-Label, Multicenter, First-in-Human, Dose-Escalation and Dose-Expansion, Phase 1/2 Study of BBI-355 and BBI-355 in Combination With Select Targeted Therapies in Subjects With Locally Advanced or Metastatic Solid Tumors With Oncogene Amplifications

Terminated·BBoundless Bio, Inc.·Phase 1·NCT05827614·85 enrolled

Biliary Tract Cancer (BTC)1 trial

Investigating Precision Medicine in the Adjuvant Setting: a Phase 3 Clinical Trial in Biliary Tract Cancer

Not yet recruiting·UUNICANCER·Phase 3·NCT07745296·990 enrolled

Advanced/Metastatic Cancer1 trial

An Open-label, Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib Study

Active, not recruiting· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Preclinical·NCT06506955·15 enrolled

Biliary Tract Cancer1 trial

A Phase 3, Randomized-Controlled, Open-Label, Multi-Regional, International Study of Futibatinib (TAS-120) and Zimberelimab (AB122) in Combination With Gemcitabine Plus Cisplatin Versus Durvalumab or Pembrolizumab in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers

Recruiting· Taiho Pharmaceutical Co., Ltd. logo

Taiho Pharmaceutical Co., Ltd.·Phase 3·NCT07710885·784 enrolled

Pediatric Cancer1 trial

European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors

Recruiting·GGustave Roussy, Cancer Campus, Grand Paris·Preclinical·NCT02813135·472 enrolled

Unspecified1 trial

Futibatinib in Patients With Specific FGFR Aberrations

Terminated· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 2·NCT04189445·115 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 30, 2022

LYTGOBI

NDA NDA214801

Sep 30, 2022

LYTGOBI

NDA NDA214801

Apr 17, 2024

LYTGOBI

NDA NDA214801

Oct 15, 2025

LYTGOBI

NDA NDA214801

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Futibatinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Futibatinib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Futibatinib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA214801). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Lytgobi. U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Futibatinib. U.S. National Library of Medicine.
[7]
SEC EDGAR — Taiho Oncology, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: FGFR Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Taiho Oncology, Inc.

Patent Landscape[5]

Patent Cliff

Feb 13, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9108973Feb 13, 2033

10434103Mar 31, 2036

11833151Nov 5, 2039

Key Publications[6]

Futibatinib in Intrahepatic Cholangiocarcinoma: FOENIX-CCA2

N Engl J MedJan 5, 2023DOI: 10.1056/NEJMoa2206834

Lytgobi

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q2 2028

Trials by Indication[1]

Bladder Cancer1 trial

Endometrial Carcinoma1 trial

Patients With Advanced Solid Tumors1 trial

Cholangiocarcinoma1 trial

Biliary Cancer1 trial

Liver Cancer1 trial

Breast Cancer1 trial

Urothelial Carcinoma1 trial

Cancer1 trial

Locally Advanced Unresectable or Metastatic Solid Tumors Including Esophageal Cancer1 trial

Lymphoma, Non-Hodgkin1 trial

Triple Negative Breast Cancer (TNBC)1 trial

Biliary Tract Cancer (BTC)1 trial

Advanced/Metastatic Cancer1 trial

Biliary Tract Cancer1 trial

Pediatric Cancer1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Key Publications[6]

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