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Balversa

(Erdafitinib)

ApprovedSmall molecule

Johnson & Johnson

Erdafitinib is used to treat a type of bladder cancer (urothelial carcinoma) that has a specific genetic mutation. It works by blocking proteins that help cancer cells grow and divide.[2] Balversa is currently approved and in use across 21 indications[4].[1]

Balversa is one of 529 small molecule programs targeting Urinary Bladder Carcinoma. It is currently in Approved.

21

Indications

30

Total Trials

15

Active Trials

528

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

8

Patents

Pipeline

Status by Indication[4][1]

Indication

Urinary Bladder CarcinomaActive, not recruiting

Prostate AdenocarcinomaApproved

Prostate CarcinomaApproved

Tic DisorderActive, not recruiting

LymphomaApproved

Brain CancerActive, not recruiting

Bladder TumorApproved

Metastatic Prostate CancerApproved

Liver DiseaseApproved

Breast CancerActive, not recruiting

Urinary Bladder CarcinomaApproved

Active, not recruiting

Prostate AdenocarcinomaApproved

Approved

Prostate CarcinomaApproved

Approved

Tic DisorderPhase 2

Active, not recruiting

LymphomaApproved

Approved

Brain CancerPhase 2

Active, not recruiting

Bladder TumorApproved

Approved

Metastatic Prostate CancerApproved

Approved

Liver DiseaseApproved

Approved

Breast CancerPhase 1

Active, not recruiting

Showing 10 of 21 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Balversa

Johnson & Johnson

Zolymbus

Methylthioninium Chloride

PProvepharm SAS

Spravato

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Aquasol E

NNational Eye Institute (NEI)

Vfend

PPrism Pharmaceuticals

Systemic Therapy

Bristol-Myers Squibb

Zoladex

Luye Pharma Group Ltd.

Beta Blocker

WWeill Medical College of Cornell University

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

Timeline

Expected Milestones

Q3 2026

Phase 2Active, not recruiting

Bladder Cancer

NCT04917809

Phase 1Active, not recruiting

Urinary Bladder Neoplasms

NCT05567185

Q4 2026

Phase 2Recruiting

Brain Cancer

NCT05859334

Phase 1Active, not recruiting

Bladder Cancer

NCT04963153

Phase 2Active, not recruiting

Tic Disorder

NCT03210714

Phase 2Active, not recruiting

Growth

NCT04083976

Clinical

Trials by Indication[1]

Bladder Cancer6 trials

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1/2·NCT05316155·235 enrolled

Drug Screening Using IMD in Bladder Cancer

Unknown status·—·Phase 1·NCT06204614·18 enrolled

A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04172675·107 enrolled

Show 3 more trials

Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04963153·24 enrolled

Testing Anti-Cancer Drugs Erdafitinib With or Without Atezolizumab in Patients With Localized Bladder Cancer Not Able to Receive Cisplatin Chemotherapy, NERA Trial

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT05564416

A Study of Oral Erdafitinib in People With Recurrent Non-Invasive Bladder Cancer

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04917809·20 enrolled

Adult2 trials

A Study to Evaluate the Effect of Fluconazole and Itraconazole on Erdafitinib Pharmacokinetics in Healthy Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03135106·54 enrolled

A Study of Steady-state Carbamazepine on the Single-dose of Erdafitinib Tablets in Healthy Adult Participants

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT04330248·15 enrolled

Growth2 trials

A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04083976·316 enrolled

Expanded Access Program (EAP) for Participants With Advanced Cancers and Fibroblast Growth Factor Receptor (FGFR) Genetic Alterations Who Have Exhausted All Treatment Options

Approved for marketing· Johnson & Johnson logo

Johnson & Johnson··NCT03825484

Tic Disorder2 trials

Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03155620·1,376 enrolled

Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03210714·20 enrolled

Prostate Cancer2 trials

Erdafitinib for the Treatment of Patients With Castration-Resistant Prostate Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT04754425·11 enrolled

Erdafitinib and Abiraterone Acetate or Enzalutamide in Treating Patients With Double Negative Prostate Cancer

Terminated·UUniversity of Washington·Phase 2·NCT03999515·3 enrolled

14 more indications

Treatment2 trials

Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Mutations or Fusions (MATCH - Subprotocol K2)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06351371·35 enrolled

Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Amplifications (MATCH-Subprotocol K1)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06308822·35 enrolled

Urothelial Cancer2 trials

A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03390504·629 enrolled

A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a Pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With FGFR Genomic Alterations

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02365597·239 enrolled

Tics1 trial

A Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03066687·16 enrolled

Hepatic Impairment1 trial

A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03587363·26 enrolled

Cancer1 trial

FGFR Inhibitor in FGFR Dysregulated Cancer

Terminated·LLung Cancer Group Cologne·Phase 2·NCT03827850·22 enrolled

Trial1 trial

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Advanced Solid Cancers1 trial

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of JNJ-63723283, an Anti-Programmed Cell Death (PD)-1 Monoclonal Antibody, as Monotherapy or in Combination With Erdafitinib in Japanese Participants With Advanced Solid Cancers

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03547037·22 enrolled

Advanced Urothelial Cancer1 trial

A Study of Erdafitinib in Participants With Metastatic or Locally Advanced Urothelial Cancer

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1/2·NCT03473743·125 enrolled

Ovarian Cancer1 trial

Erdafitinib in Metastatic Steroid-cell Ovarian Cancer

Completed·UUniversity Health Network, Toronto·N/A·NCT06328491·1 enrolled

Breast Cancer1 trial

Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer

Completed·VVanderbilt-Ingram Cancer Center·Phase 1·NCT03238196·35 enrolled

Cholangiocarcinoma1 trial

A Study to Evaluate the Clinical Efficacy of JNJ-42756493 (Erdafitinib), A Pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, In Asian Participants With Advanced Non-Small-Cell Lung Cancer, Urothelial Cancer, Esophageal Cancer Or Cholangiocarcinoma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02699606·35 enrolled

Brain Cancer1 trial

Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05859334·30 enrolled

Advanced Lymphoma1 trial

Molecular Analysis for Therapy Choice (MATCH)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02465060·6,452 enrolled

Urinary Bladder Neoplasms1 trial

A Phase 1 Study to Evaluate the Tolerability, Safety, and Pharmacokinetics of TAR-210 in Japanese Participants With Bladder Cancer and Selected FGFR Mutations or Fusions

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05567185·5 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 12, 2019

BALVERSA

NDA NDA212018

Sources

References

[1]
ClinicalTrials.gov — 30 trial records for Erdafitinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Balversa drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Erdafitinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Erdafitinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA212018). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Balversa. U.S. Food & Drug Administration.
[7]
PubMed — 1 publication indexed for Erdafitinib. U.S. National Library of Medicine.
[8]
SEC EDGAR — Johnson & Johnson company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: FGFR Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Johnson & Johnson

Patent Landscape[6]

Patent Cliff

Apr 28, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9464071Apr 28, 2031

8895601Apr 12, 2033

9902714Mar 26, 2035

12037644Oct 18, 2035

11684620Feb 9, 2036

3 more patents

10898482Feb 9, 2036

10478494Aug 13, 2036

11077106Feb 2, 2038

Key Publications[7]

Erdafitinib in FGFR-Altered Advanced Urothelial Carcinoma: THOR

N Engl J MedMay 4, 2023DOI: 10.1056/NEJMoa2308849

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