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Erdafitinib

Alternative Names: erdafitinib, jnj-42756493, balversa
Latest Update: 2024-12-18
Latest Update Note: Clinical Trial Update

Product Description

Erdafitinib, a tyrosine kinase inhibitor of FGFR1–4, has shown antitumor activity in preclinical models and in a phase 1 study involving patients with FGFR alterations. (Sourced from: https://www.nejm.org/doi/full/10.1056/nejmoa1817323)

Mechanisms of Action: FGFR Antagonist

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: None *

Approval Status: Approved

Approved Countries: Bangladesh | Brazil | Canada | Chile | Egypt | Hong Kong | Israel | Jordan | Korea | Mexico | Peru | Philippines | Saudi Arabia | Singapore | Taiwan | Turkey | United States

Approved Indications: Transitional Cell Carcinoma | Oncology Unspecified

Known Adverse Events: Abdominal Pain | Dysgeusia | Labor Pain | Pain Unspecified | Alopecia | Onycholysis | Mouth Abnormalities | Stomatitis | Musculoskeletal Pain | Skin Abnormalities | Hyperphosphatemia | Keratoconjunctivitis Sicca | Dry Eye Syndromes | Contraception | Pregnancy Outcomes | Pregnancy, Abdominal | Constipation | Diarrhea

Company: Johnson & Johnson
Company Location: NEW BRUNSWICK NJ 08933
Company CEO: Joaquin Duato
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Erdafitinib

Countries in Clinic: Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Russia, Spain, Taiwan, Turkey, Ukraine, United Kingdom, United States

Active Clinical Trial Count: 23

Highest Development Phases

Phase 3: Bladder Cancer|Muscle Cancer|Transitional Cell Carcinoma

Phase 2: Cholangiocarcinoma|Oncology Solid Tumor Unspecified

Phase 1: Healthy Volunteers|Liver Cancer

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
SOGUG-NEOWIN TRIAL

P2

Active, not recruiting

Muscle Cancer|Bladder Cancer

2029-02-01

42756493BLC3004

P3

Unknown Status

Muscle Cancer|Bladder Cancer

2028-06-28

CR109115

P1

Recruiting

Muscle Cancer|Bladder Cancer|Liver Cancer

2028-03-30

TAR-210

P1

Recruiting

Liver Cancer|Bladder Cancer

2026-10-16

Recent News Events

Date

Type

Title

10/24/2024

News Article

 Tyra Biosciences Reports Interim Clinical Proof-of-Concept Data for TYRA-300, an Investigational Oral FGFR3-Selective Inhibitor, in Phase 1/2 SURF301 Study in Patients with Metastatic Urothelial Cancer (mUC)

10/15/2024

News Article

 Johnson & Johnson Reports Q3 2024 Results

07/17/2024

News Article

 Johnson & Johnson reports Q2 2024 results

06/14/2024

News Article

 2024 Urology Care Foundation Research Scholar Awardees Announced

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