darolutamide (Nubeqa) Report issue

Small molecule Approved FDA Fast Track FDA Priority Review FDA
AACT ChEMBL DrugBank MeSH PubChem

Active Ingredient History

NOW
  • Now
ODM-201 (also known as BAY-1841788) is a non-steroidal antiandrogen, specifically, a full and high-affinity antagonist of the androgen receptor (AR), that is under development by Orion and Bayer HealthCare for the treatment of advanced, castration-resistant prostate cancer (CRPC). ODM-201 appears to negligibly cross the blood-brain-barrier. This is beneficial due to the reduced risk of seizures and other central side effects from off-target GABAA receptor inhibition that tends to occur in non-steroidal antiandrogens that are structurally similar to enzalutamide. Moreover, in accordance with its lack of central penetration, ODM-201 does not seem to increase testosterone levels in mice or humans, unlike other non-steroidal antiandrogens. Another advantage is that ODM-201 has been found to block the activity of all tested/well-known mutant ARs in prostate cancer, including the recently-identified clinically-relevant F876L mutation. ODM-201 has been studied in phase I and phase II clinical trials and has thus far been found to be effective and well-tolerated, with the most commonly reported side effects including fatigue, nausea, and diarrhea. No seizures have been observed.   NCATS

Chemistry

  • SMILES: C[C@@H](CN1C=CC(=N1)C2=CC(Cl)=C(C=C2)C#N)NC(=O)C3=NNC(=C3)C(C)O
  • InChIKey: BLIJXOOIHRSQRB-PXYINDEMSA-N
  • Mol. Mass: 398.846
  • ALogP: 2.67
  • ChEMBL Molecules:
    odm-201  
    darolutamide  
More Chemistry

Pharmacology

  • Mechanism of Action:
  • Multi-specific: Missing data
  • Black Box: No
  • Availability: Prescription Only
  • Delivery Methods: Missing data
  • Pro Drug: No

Drug Pricing (per unit)

United States

$62.4824 - $86.6251
More Pricing Detail

Note: This drug pricing data is preliminary, incomplete, and may contain errors.

Alternative names

bay 1841788 | bay-1841788 | darolutamide | odm-201 | orm-16497 | orm-16555

Organizations (63)

Research & Development (63)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Marketing (1)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Indications (17)

Approved Indications (2)


 

Prostatic Neoplasms

Prostatic Neoplasms, Castration-Resistant (approved 2019)

Experimental Indications - Clinical Trial Phases 1-4 (17)


 

Biological Availability (Phase 1)

Breast Neoplasms (Phase 2)

Carcinoma (Phase 2)

Cerebrovascular Circulation (Phase 1)

Drug Interactions (Phase 1)

Drug Therapy (Phase 2)

Healthy Volunteers (Phase 1)

Hepatic Insufficiency (Phase 1)

Neoadjuvant Therapy (Phase 2)

Neoplasm Metastasis (Phase 2)

Neoplasms (Phase 3)

Pharmacokinetics (Phase 1)

Prostatic Neoplasms (Phase 3)

Prostatic Neoplasms, Castration-Resistant (Phase 3)

Renal Insufficiency (Phase 1)

Salivary Gland Neoplasms (Phase 2)

Triple Negative Breast Neoplasms (Phase 2)

Overview

  • Highest Phase: Phase 4
  • # of Trials: 61
  • # of Trial Organizations: 63

Trials by Phase

Trial Phase Start Date Organizations Indications

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