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Talazoparib with enzalutamide

Phase 3
PFIZER (PFE)

Phase 3

Development Phase

0

Upcoming Catalysts

0

Historical Events

4

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

0 competitors in mCRPC

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Drug Information

Target Indication

mCRPC

Clinical Trial

NCT03395197

Last updated: 12/13/2025

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMAPending

Enzalutamide Accordpharma

Treatment of prostate cancer.

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EMA8/22/2024

Enzalutamide Viatris

Enzalutamide Viatris is indicated:• as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 5.1);• in combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1); • for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1);• for the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1);• for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.

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EMA6/20/2019

Talzenna

Treatment with Talzenna should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Patient selection Breast cancer: Patients should be selected for the treatment of breast cancer with Talzenna based on the presence of deleterious or suspected deleterious germline BRCA mutations determined by an experienced laboratory using a validated test method. Genetic counselling for patients with BRCA mutations should be performed according to local regulations, as applicable. Prostate cancer: There is no requirement for tumour mutation testing for selection of patients with mCRPC for treatment with Talzenna.

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EMA6/21/2013

Xtandi

Xtandi is indicated for: as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy (see section 5.1). the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1). the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1). the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.

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Drug Science
Mechanism of action & safety profile
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