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Mevrometostat

Phase 3

Metastatic Castration Sensitive Prostate Cancer (mCSPC) | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Aug 14, 2026

Target and mechanism

Target class-Stat (Enzyme)
ModalitySmall molecule

Also known as PF-06821497, Mervometostat (PF-06821497), Mervometostat

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment1,000

FDA Designations

No designations recorded

Clinical trial landscape

Mevrometostat · 1 trial · 4 indications

Phase 3 1
NCT07028853This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.Metastatic Castration Sensitive Prostate Cancer (mCSPC)
RECRUITING1,000 Analytics
PHASE3RECRUITING
This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.
Metastatic Castration Sensitive Prostate Cancer (mCSPC)Unlock trial analytics

Study Endpoints

Primary Endpoints

Radiographic Progression Free Survival (rPFS)
Randomization up to approximately 4 years

rPFS is defined as the time from randomization until PD based on BICR assessment per RECIST v1.1 (soft tissue disease) and PCWG3 (bone disease), or death due to any cause, whichever occurs first.

Secondary Endpoints

Overall survival (OS)
Randomization up to approximately 9 years
Objective response in measurable soft tissue disease
Randomization up to approximately 4 years
Duration of Response (DoR) in measurable soft tissue disease
Randomization up to approximately 4 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTALParticipants will receive mevrometostat/PF-06821497 (875 mg) BID (twice daily) + enzalutamide 160 mg QD (once daily)
Arm BACTIVE_COMPARATORParticipants will receive Placebo BID (twice daily) + enzalutamide 160 mg QD (once daily)

Interventions

NameTypeDescription
MevrometostatDRUGOral continuous
PlaceboDRUGOral continuous
EnzalutamideDRUGOral continuous
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites337

Inclusion Criteria * Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening. * Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features. * Metastatic prostate cancer documented by positive bone s...

Countries:United StatesArgentinaAustraliaBelgiumBrazilBulgariaCanadaChinaCzechiaFinlandFranceGermanyGreeceIsraelItalyJapanNetherlandsNew ZealandPolandSlovakiaSouth KoreaSpainSwitzerlandTaiwanTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)

LOWAug 14, 2026NCT07028853lastUpdatePostDate: changed
LOWAug 14, 2026NCT07028853lastUpdatePostDate: changed
LOWJul 30, 2026NCT07028853lastUpdatePostDate: changed
LOWJul 30, 2026NCT07028853lastUpdatePostDate: changed
LOWJul 9, 2026NCT07028853lastUpdatePostDate: changed
LOWJul 9, 2026NCT07028853lastUpdatePostDate: changed
LOWJun 30, 2026NCT07028853lastUpdatePostDate: changed
LOWJun 30, 2026NCT07028853lastUpdatePostDate: changed
LOWJun 30, 2026NCT07028853lastUpdatePostDate: changed
LOWJun 23, 2026NCT07028853lastUpdatePostDate: changed
LOWJun 23, 2026NCT07028853lastUpdatePostDate: changed
LOWJun 10, 2026NCT07028853lastUpdatePostDate: changed
LOWJun 10, 2026NCT07028853lastUpdatePostDate: changed

Frequently asked questions about Mevrometostat

What is Mervometostat used for?

Mervometostat is an investigational small molecule being developed by Pfizer for metastatic castration-resistant prostate cancer (mCRPC) and metastatic castration-sensitive prostate cancer (mCSPC). It is also being studied in healthy participants to understand how the drug is processed by the body.

How does Mervometostat work?

Mervometostat is a small molecule enzyme inhibitor, classified under the -stat (enzyme) target class. It is being studied to treat prostate cancer by targeting specific enzymes involved in cancer growth, though the exact molecular target is not disclosed in the available information.

Who makes Mervometostat?

Mervometostat is developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is also known by the code name PF-06821497.

What phase is Mervometostat in?

Mervometostat is in Phase 1 clinical development for metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer. It is also being studied in healthy participants. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Mervometostat in?

Mervometostat is being studied in several clinical trials. NCT03460977 is a Phase 1 trial in mCRPC, small cell lung cancer, and follicular lymphoma. NCT06392230 is a completed Phase 1 trial in healthy participants. NCT06629779 is a Phase 3 trial in mCRPC, and NCT07028853 is a Phase 3 trial in mCSPC.

Is Mervometostat the same as PF-06821497?

Yes, Mervometostat is also known as PF-06821497. The drug is referred to by both names in clinical trial registries and scientific literature, with PF-06821497 being the code name used during early development.