TheraRadar
Data updated: May 26, 2026

NUBEQA (darolutamide)

Trial Activity: Growth 39 active trials
Priority Review Fast Track
Oncology Approved 2019-07-30

NUBEQA is indicated for the treatment of Prostate Cancer.

Source: FDA Label • Bayer
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How NUBEQA Works

This drug works by blocking androgen receptors, which prevents male hormones from binding to cancer cells and moving into the cell nucleus. By inhibiting this hormonal signaling and the resulting gene transcription, the medication decreases the proliferation of prostate cancer cells and reduces tumor volume.

Source: FDA Label

Development Insights

AstraZeneca conducting 3 trials (6%)
102 indications explored (Broad Platform)
→ prostate cancer (17 trials)
→ metastatic castration-resistant prostate cancer (6 trials)
→ metastatic prostate cancer (5 trials)
4
Indications
--
Phase 3 Trials
3
Priority Reviews
6
Years on Market

Details

Status
Prescription
First Approved
2019-07-30
Patent Cliff
2042

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET

Companies

Bayer
Active Ingredient: DAROLUTAMIDE

NUBEQA Approval History

2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2019 to 2025 · 3 indication expansions
Jun 2025 SUPPL
Efficacy
FDA Letter Label
Oct 2023 SUPPL
Label · Labeling
FDA Letter Label
Aug 2022 SUPPL Priority
Efficacy
FDA Letter Label

What NUBEQA Treats

1 indications

NUBEQA is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Prostate Cancer
Source: FDA Label

NUBEQA Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

5

Same target(s) AND same indication — head-to-head.

APALUTAMIDE
ZYDUS
2025 2 indic.
ERLEADA
Johnson &
2018 2 indic.

MoA expansion candidates

4

Same target(s), different indications — where else is this mechanism being explored?

MYFEMBREE
SUMITOMO PHARMA
2021 3 indic.
MIFEPRISTONE
Teva
2019 5 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

CONJUGATED ESTROGENS
NOVAST LABS
2025 6 indic.
BILDYOS
SHANGHAI HENLIUS
2025 4 indic.
Unlock 13 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in NUBEQA's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications NUBEQA treats. First-in-class if their pivotal trials read out positive.

Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca
ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials

Drugs Similar to NUBEQA

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AKEEGA
ABIRATERONE ACETATE
1 shared
Johnson & Johnson
Shared indications:
Prostate Cancer
AMICAR
AMINOCAPROIC ACID
1 shared
EPIC PHARMA LLC
Shared indications:
Prostate Cancer
AMINOCAPROIC ACID
AMINOCAPROIC ACID
1 shared
AJENAT PHARMS
Shared indications:
Prostate Cancer
View all 20 similar drugs Pro
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Clinical Trial Registry

47 trials
Trial Sponsor ID Phase Status Title
NCT06169124 NCI-2023-06524 NCI-2023-06524, NRG-GY033 Ph 2 active not recruiting Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors
NCT07450599 CHINANEO 22982 Ph 2 recruiting A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.
NCT05669664 NCI-2022-10701 NCI-2022-10701, 10553 Ph 2 active not recruiting Testing the Anti-cancer Drug Darolutamide in Patients With Testosterone-Driven Salivary Gland Cancers
NCT07190300 TulmiSTAR-02 CDZR123C12101 2025-521873-15-00 Ph 1, Ph 2 recruiting TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
NCT05818683 CR109321 78278343PCR1003, 2022-503132-14-00 Ph 1 recruiting A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer
NCT04136353 DASL-HiCaP ANZUP1801 U1111-1239-0771 Ph 3 active not recruiting Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate
NCT04484818 EA8183 NCI-2020-02383, EA8183 Ph 3 active not recruiting Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study
NCT07140900 20240361 Ph 1 recruiting Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer
NCT05050084 NRG-GU010 NCI-2021-08760, NRG-GU010 Ph 3 active not recruiting Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial
NCT04925648 PICASSO PICASSO Ph 2 completed Psma Intensity Can be Altered by Androgen and Phospho-SrC Obstruction
NCT06378866 DIVINE MC230502 R01CA286127, 23-012176 Ph 2 recruiting Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial
NCT06220864 SNV1521-101 Ph 1 recruiting SNV1521 in Participants With Advanced Solid Tumors
NCT06190899 CELC-G-201 Ph 1, Ph 2 recruiting Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer
NCT05694819 YCU19003 jRCT2031190241 Ph 2 completed Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma (DISCOVARY)
NCT06120491 EvoPAR-PR01 D9723C00001 2023-504214-30-00 Ph 3 recruiting Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents
NCT06401980 SAKK 08/23 Ph 2 recruiting Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
NCT06282588 THUNDER CTO21042GZA Ph 2, Ph 3 recruiting Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers
NCT07027124 STUDY-23-01400 Ph 2 recruiting Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer
NCT07476677 ANDARP 24/605-4885 Ph 2 not yet recruiting Darolutamide ± ADT as Neoadjuvant Therapy in High-Risk/Very High-Risk Localized Prostate Cancer
NCT06173362 UCDCC315 NCI-2023-09814, UCDCC315 Ph 2 recruiting Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer
NCT07142551 J2564 IRB00509292 Ph 2 recruiting Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response
NCT06463457 24-217 Ph 2 active not recruiting Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)
NCT05999968 18714 I3Y-MC-JPEI, 2023-503919-15-00 Ph 1 completed Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment
NCT05617885 22-422 Ph 1 active not recruiting Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer
NCT05938270 ASCERTAIN D9721C00002 2023-503691-25-00 Ph 1 recruiting A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.
NCT04558866 ExBAT LACOG 0620 Ph 2 active not recruiting Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial)
NCT06631521 IIR-US-00295 2077841 Ph 1 recruiting Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
NCT07244341 DS3201-343 2025-522512-16-00 Ph 1 recruiting A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)
NCT05519449 PSMA-007-001 ENGAGER-PSMA-01 Ph 1 recruiting Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)
NCT06660862 IRB24-0691 Ph 4 not yet recruiting Evaluating Treatment Outcomes Using Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer.
NCT04025372 19-202 Ph 2 active not recruiting INTREPId (INTermediate Risk Erection PreservatIon Trial)
NCT05367440 PETRANHA D9720C00003 2023-508536-64-00, 2021-006289-19 Ph 1, Ph 2 active not recruiting Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer
NCT04335682 ARACOG AFT-47 Ph 2 active not recruiting Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide
NCT07016399 VICC-VCBRE23490 NCI-2025-03600, VICC-VCBRE23490 Ph 2 recruiting Neoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBC
NCT04319783 DECREASE TROG 19.06 U1111-1242-9233 Ph 2 active not recruiting Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA
NCT03385655 I234 Ph 2 active not recruiting Prostate Cancer Biomarker Enrichment and Treatment Selection
NCT03568656 CCS1477-01 Ph 1, Ph 2 completed Study to Evaluate CCS1477 in Advanced Tumours
NCT06625970 PEACE 7 UC-GTG-2310 2023-509787-15-00 Ph 3 recruiting Study Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse
NCT03903835 ProBio EudraCT No 2018-002350-78 Ph 3 recruiting ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer
NCT06575257 KY20242118-C-1 Ph 2 recruiting Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer
NCT05762536 DAROTAXEL NL83539.078.23 Ph 2 recruiting Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC
NCT05272709 CURATE CRUKD/21/005 2021-001062-37 Ph 1, Ph 2 recruiting TT-702 in Patients With Advanced Solid Tumours.
NCT03878524 STUDY00015588 NCI-2020-02743, STUDY00015588 Ph 1 terminated Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial
NCT04176081 SChLAP/IDC SChLAP/IDC Study Ph 2 not yet recruiting Study of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate Cancer
NCT04737109 ADDItion results posted BTCRC-GU19-404 Ph 1, Ph 2 terminated Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate Cancer
NCT05771896 CARE 00019_CARE Ph 3 withdrawn Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With mCSPC
NCT03383679 START UC-0140/1711 - UCBG3-06 2017-002284-18 Ph 2 completed Study on Androgen Receptor and Triple Negative Breast Cancer
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

NUBEQA FDA Label Details

Indications & Usage

FDA Label (PDF)

NUBEQA is indicated for the treatment of Prostate Cancer.

View full patent landscape →
9 OB patents · 4 families · 187 international docs across 39 countries

NUBEQA Patents & Exclusivity

Latest Patent: Jun 2042
Exclusivity: Jun 2028

Patents (9 active)

US12329742 Expires Jun 17, 2042
US11168058 Expires Feb 27, 2038
US10835515 Expires Jan 28, 2036
US10010530 Expires Jan 28, 2036
US10383853 Expires Jan 28, 2036
US8975254 Expires Mar 25, 2033
US9657003 Expires Oct 27, 2030
US11046713 Expires Oct 27, 2030
US10711013 Expires Oct 27, 2030

Exclusivity

I-971 Until Jun 2028
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for NUBEQA

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2042
  • • 16 active patents

Trial Analysis

  • • 47 total trials
  • • Stage: Growth

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA212099 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment