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 18 indications[4].[1]
Nubeqa is one of 246 small molecule programs targeting Prostate Adenocarcinoma. It is currently in Approved.
18
Indications
91
Total Trials
67
Active Trials
245
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
10
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 18 indications
Competition
Competitive Landscape
2828 competitors in Breast Cancer
#DrugCompanyPhaseTrials
1Nubeqa
BayerApproved
Tykerb
GSKPreclinical
Prolia
AmgenPreclinical
Cymbalta
Alnylam PharmaceuticalsPreclinical
Feraheme
AAzurity Pharmaceuticals
Preclinical
Aquasol E
NNational Eye Institute (NEI)
Preclinical
Apatinib Mesylate
BBukwang Pharmaceutical
Preclinical
Metfomin
UUniversity of Texas Southwestern Medical Center
Preclinical
Iniparib
SanofiPreclinical
Promestriene
UUniversity of Sao Paulo General Hospital
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Prostate Cancer42 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 39 more trials
Darolutamide ± ADT as Neoadjuvant Therapy in High-Risk/Very High-Risk Localized Prostate Cancer
Not yet recruiting·—·Phase 2·NCT07476677·60 enrolled
COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer
Active, not recruiting·—·Phase 4·NCT06627530·144 enrolled
Metastatic Prostate Cancer7 trials
Show 4 more trials
Non-metastatic Castration-resistant Prostate Cancer3 trials
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)3 trials
31 more indications
Trial2 trials
INTREPId (INTermediate Risk Erection PreservatIon Trial)
Active, not recruiting·—·Phase 2·NCT04025372·234 enrolled
Prostatic Neoplasms2 trials
Metastatic Castration-Resistant Prostate Cancer2 trials
Survival1 trial
Imaging1 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
Radiation Therapy1 trial
First Line Therapy1 trial
Testosterone1 trial
Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response
Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT07142551·60 enrolled
Cancer of the Prostate1 trial
Progression-Free Survival1 trial
Salivary Gland Carcinoma1 trial
Neoadjuvant1 trial
Observational Study1 trial
Ovarian Granulosa Cell Tumor1 trial
Cognitive Function1 trial
Salivary Gland Cancer1 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
Metastatic Hormone Sensitive Prostate Cancer1 trial
Metastatic Castration-resistant Prostate Neoplasms1 trial
Prostate Carcinoma1 trial
Advanced Solid Tumor1 trial
Prostate Adenocarcinoma1 trial
Localized Prostate Cancer1 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]