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Rinzimetostat

Phase 3

Metastatic Castration Resistant Prostate Cancer | Small molecule | Oncology |Oric Pharmaceuticals, Inc.|Last Updated: Sep 3, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment600

FDA Designations

No designations recorded

Clinical trial landscape

Rinzimetostat · 1 trial · 1 indication

Phase 3 1
NCT07723248A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)Metastatic Castration Resistant Prostate Cancer
RECRUITING600 Analytics
PHASE3RECRUITING
A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)
Metastatic Castration Resistant Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Radiographic Progression Free Survival assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
Randomization up to ~2 years

Radiographic Progression Free Survival is defined as the time from the date of randomization to first evidence of radiographic progression as assessed in soft tissue by RECIST 1.1 or in bone per PCWG3 guideline by BICR, or death, whichever occurs first

Secondary Endpoints

Overall Survival (OS)
5 years
Objective response rate (ORR)
Randomization up to ~2 years
Duration of Response (DoR)
Randomization up to ~2 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Investigational ArmACTIVE_COMPARATORRinzimetostat + darolutamide
Physician's ChoiceACTIVE_COMPARATORControl Arm

Interventions

NameTypeDescription
RinzimetostatDRUG400 mg once daily (QD)
DarolutamideDRUG600 mg twice daily (BID)
EnzalutamideDRUG160 mg once daily (QD)
DocetaxelDRUG75 mg/m2 intravenously (IV) every 21 days for up to 10 cycles
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features * Progressive disease in the setting of surgical or medical castration with evidence of disease progression on treatment with abiraterone acetate in the mCSPC setting or first ...

Countries:United States
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Recent Changes (Last 90 Days)

LOWSep 3, 2026NCT07723248startDate: changed
LOWSep 3, 2026NCT07723248startDate: changed
LOWJul 24, 2026NCT07723248NEW_TRIAL: changed
LOWJul 24, 2026NCT07723248NEW_TRIAL: changed

Frequently asked questions about Rinzimetostat

What is Rinzimetostat used for in metastatic castration resistant prostate cancer?

Rinzimetostat is an investigational small molecule being studied for the treatment of metastatic castration resistant prostate cancer (mCRPC). It is currently in Phase 3 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in patients who were previously treated with abiraterone acetate.

What does Rinzimetostat target?

Rinzimetostat is a small molecule enzyme inhibitor, as indicated by its '-stat' suffix, which typically denotes enzyme inhibition. The specific molecular target has not been disclosed in available information. The drug is being investigated for its potential role in treating metastatic castration resistant prostate cancer.

Who makes Rinzimetostat?

Rinzimetostat is being developed by Oric Pharmaceuticals, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol ORIC. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with metastatic castration resistant prostate cancer.

What phase is Rinzimetostat in?

Rinzimetostat is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval for commercial use. The Phase 3 trial is actively recruiting participants to further assess the drug's effectiveness in treating metastatic castration resistant prostate cancer.

What clinical trials is Rinzimetostat in?

Rinzimetostat is being studied in a Phase 3 clinical trial registered as NCT07723248, titled 'A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)'. The trial is actively recruiting 600 male participants aged 18 years and older in the United States.

Is Rinzimetostat the same as ORIC-944?

Yes, Rinzimetostat is also known as ORIC-944. The clinical trial NCT07723248 refers to the drug as 'Rinzimetostat (ORIC-944)', confirming that both names refer to the same investigational compound being developed by Oric Pharmaceuticals for metastatic castration resistant prostate cancer.