Standard Darolutamide

Phase 3Small molecule

Standard Darolutamide is one of 10 small molecule programs targeting Metastatic Hormone-Sensitive Prostate Cancer (mHSPC). It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Metastatic Hormone-Sensitive Prostate Cancer (mhspc)Active, not recruiting

Metastatic Hormone-Sensitive Prostate Cancer (mhspc)Phase 3

Active, not recruiting

Competition

Competitive Landscape

9 competitors in Metastatic Hormone-Sensitive Prostate Cancer (mhspc)

#DrugCompanyPhaseTrials

Nubeqa

Bayer

Phase 3

6 2

Zytiga

Johnson & Johnson

Phase 3

3 3

Xtandi

Astellas

Phase 3

1 4

Taxotere

AAvyxa

Phase 3

1 5

Saruparib

AstraZeneca

Phase 3

1 6

Orgovyx

Sumitomo Pharma America, Inc.

Phase 2

1 7

Standard ADT

Bayer

Phase 3

1 8

Standard Darolutamide

JJena University Hospital

Phase 3

1 9

Xaluritamig

Amgen

Phase 1

1 10

Tulmimetostat

Novartis

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Metastatic Hormone-Sensitive Prostate Cancer (mhspc)

NCT05676203

Clinical

Trials by Indication[1]

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)1 trial

A Randomised, Phase 3 Trial Comparing 3-weekly Docetaxel 75 mg/m2 (in a 3 Week Cycle) Versus 2-weekly Docetaxel 50 mg/m2 (in a 4 Week Cycle) in Combination With Darolutamide + ADT in Patients With mHSPC

Active, not recruiting·JJena University Hospital·Phase 3·NCT05676203·250 enrolled

Sources

References

[1]
ClinicalTrials.gov — 1 trial record for Standard Darolutamide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Standard Darolutamide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Standard Darolutamide. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Jena University Hospital company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: JJena University Hospital

Standard Darolutamide

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)1 trial

References

Drug Info

Quick Facts

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