Nubeqa
(Darolutamide)ApprovedSmall molecule
BayerDarolutamide is used to treat men with prostate cancer that hasn't spread to other parts of the body. It works by blocking male hormones that help prostate cancer grow.[2] Nubeqa is currently approved and in use across 29 indications[4].[1]
Nubeqa is one of 348 small molecule programs targeting Prostate Cancer. It is currently in Approved.
29
Indications
99
Total Trials
73
Active Trials
347
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
10
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 29 indications
Competition
Competitive Landscape
350 competitors in Treatment
#DrugCompanyPhaseTrials
1Nubeqa
BayerApproved
Dexilant
TakedaPreclinical
Theo-Dur
PfizerPreclinical
Levulan
Sun Pharmaceutical Industries, Inc.Preclinical
Valium
Akero TherapeuticsPreclinical
Clomid
FerringPreclinical
Aurlumyn
BBTG International Inc.
Preclinical
Lotemax
PPharmos
Preclinical
Norpramin
VValidus Pharmaceuticals
Preclinical
Barhemsys
Tibotec Pharmaceuticals, IrelandPreclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Prostate Cancer38 trials
Efficacy and Safety of Darolutamide Combined With ADT in High-risk/Very High-risk Localized Prostate Cancer
Unknown status·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Phase 2·NCT05249712·30 enrolled
Show 35 more trials
COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer
Active, not recruiting·—·Phase 4·NCT06627530·144 enrolled
Darolutamide ± ADT as Neoadjuvant Therapy in High-Risk/Very High-Risk Localized Prostate Cancer
Not yet recruiting·—·Phase 2·NCT07476677·60 enrolled
Metastatic Prostate Cancer7 trials
Show 4 more trials
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)6 trials
Show 3 more trials
Metastatic Castration-Resistant Prostate Cancer4 trials
36 more indications
Breast Cancer2 trials
Trial2 trials
INTREPId (INTermediate Risk Erection PreservatIon Trial)
Active, not recruiting·—·Phase 2·NCT04025372·234 enrolled
Metastatic Hormone Sensitive Prostate Cancer2 trials
Solid Tumor2 trials
Prostatic Neoplasms2 trials
Cancer of the Prostate1 trial
Imaging1 trial
Androgen Deprivation Therapy1 trial
Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)
Active, not recruiting·—·Phase 2·NCT06463457·33 enrolled
Progression-Free Survival1 trial
Treatment1 trial
Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC
Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 3·NCT06177015·200 enrolled
Survival1 trial
Salivary Gland Carcinoma1 trial
Radiation Therapy1 trial
Cognitive Function1 trial
Testosterone1 trial
Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response
Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT07142551·60 enrolled
Observational Study1 trial
Neoadjuvant1 trial
First Line Therapy1 trial
mHSPC1 trial
Metastatic Castration-resistant Prostate Neoplasms1 trial
Castration Sensitive Prostate Cancer1 trial
Prostate Adenocarcinoma1 trial
Localized Prostate Cancer1 trial
Locally Advanced Salivary Gland Carcinoma1 trial
High Risk Prostate Carcinoma1 trial
Metastatic Castration-sensitive Prostate Cancer1 trial
Adult Ovarian Granulosa Cell Tumor1 trial
Prostate Carcinoma1 trial
Recurrent Castration-Sensitive Prostate Carcinoma1 trial
Advanced Solid Tumor1 trial
Regulatory
FDA Approval Timeline[5]
Jul 30, 2019
NUBEQA
NDA NDA212099
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Nubeqa drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Darolutamide. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]FDA Orange Book — Patent and exclusivity data for Nubeqa. U.S. Food & Drug Administration.
- [7]