Lytgobi

(Futibatinib)

Phase 3Small molecule

Lytgobi is a small molecule that works as a FGFR Inhibitor.[2] It is being investigated across 7 indications, with its most advanced program in Phase 3.[1]

Lytgobi is one of 210 small molecule programs targeting Liver Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

209

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Liver CancerActive, not recruiting

Endometrial CarcinomaActive, not recruiting

Breast CancerActive, not recruiting

Bladder CancerActive, not recruiting

CholangiocarcinomaActive, not recruiting

Pediatric CancerRecruiting

Urothelial CarcinomaActive, not recruiting

Liver CancerPhase 2

Active, not recruiting

Endometrial CarcinomaPhase 2

Active, not recruiting

Breast CancerPhase 2

Active, not recruiting

Bladder CancerPhase 2

Active, not recruiting

CholangiocarcinomaPhase 3

Active, not recruiting

Pediatric CancerPreclinical

Recruiting

Urothelial CarcinomaPhase 2

Active, not recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Lytgobi

Taiho Oncology, Inc.

Phase 3

1 2

Halaven

Eisai

Preclinical

38 3

Adriamycin

GGynecologic Oncology Group

Preclinical

87 4

DATROWAY

Daiichi Sankyo

Preclinical

4 5

Aquasol E

NNational Eye Institute (NEI)

Preclinical

—6

Vit D

PPost Graduate Institute of Medical Education and Research, Chandigarh

Preclinical

1 7

Motexafin Gadolinium

PPharmacyclics LLC.

Preclinical

1 8

Naltrexone/bupropion

Novo Nordisk

Preclinical

1 9

Iniparib

Sanofi

Preclinical

6 10

Ablavar

LLantheus Medical Imaging

Preclinical

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

Pd-1antibody

NCT05945823

Phase 1Active, not recruiting

Tumors

NCT05827614

Q2 2028

Phase 3Recruiting

Biliary Cancer

NCT05615818

Q4 2028

Phase 2Recruiting

Advanced Stage Cancer

NCT02693535

Clinical

Trials by Indication[1]

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

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

PD-1antibody1 trial

Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors

Active, not recruiting· Taiho Oncology, Inc. logo

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

10 more indications

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

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

Advanced Stage Cancer1 trial

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

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

Combination Therapy1 trial

Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy.

Enrolling by invitation· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 2/3·NCT06506955·15 enrolled

Tumors1 trial

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

Active, not recruiting·BBoundless Bio, Inc.·Phase 1·NCT05827614·85 enrolled

Biliary Cancer1 trial

Personalized Medicine for Advanced Biliary Cancer Patients

Recruiting·UUNICANCER·Phase 3·NCT05615818·800 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

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

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

Sources

References

[1]
ClinicalTrials.gov — 15 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 2028

Q4 2028

Trials by Indication[1]

Endometrial Carcinoma1 trial

Bladder Cancer1 trial

PD-1antibody1 trial

Breast Cancer1 trial

Urothelial Carcinoma1 trial

Cancer1 trial

Liver Cancer1 trial

Advanced Stage Cancer1 trial

Combination Therapy1 trial

Tumors1 trial

Biliary Cancer1 trial

Cholangiocarcinoma1 trial

Patients With Advanced Solid Tumors1 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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