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  1. pharmadog
  2. ›drugs
  3. ›Xtandi
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enzalutamide

Marketedupdated 5mo ago
by Alessa Therapeutics Inc
Approved
community read0 votes

🐶 often sniffed alongside

top 3
  • tagApproval112 co-mentions · 28 sources
  • drugXTANDI112 co-mentions · 28 sources
  • tagSmall Molecule56 co-mentions · 28 sources

indications

investigational
Prostate Cancer

all catalysts(28)

approval · 28
Aug 31, 2012
approval
14y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Mar 19, 2013
approval
14y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
May 23, 2014
approval
12y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Sep 10, 2014
approval
12y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Jul 21, 2015
approval
11y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Aug 5, 2015
approval
11y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Oct 1, 2015
approval
11y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Nov 6, 2015
approval
11y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Jul 14, 2016
approval
10y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Oct 20, 2016
approval
10y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Jul 24, 2017
approval
9y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Jul 13, 2018
approval
8y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Dec 16, 2019
approval
7y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Aug 4, 2020
approval
6y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Oct 23, 2020
approval
6y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
May 24, 2021
approval
5y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Jan 13, 2022
approval
5y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Jan 13, 2022
approval
5y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Sep 9, 2022
approval
4y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Sep 9, 2022
approval
4y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Nov 16, 2023
approval
3y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Nov 16, 2023
approval
3y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Jan 22, 2025
approval
2y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Jan 22, 2025
approval
2y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Mar 21, 2025
approval
2y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Mar 21, 2025
approval
2y ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Dec 11, 2025
approval
10mo ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
Dec 11, 2025
approval
10mo ago
XTANDI (ENZALUTAMIDE) — FDA approval
enzalutamide
→
view all 28 catalysts →

Trials studying enzalutamide

  • phase3A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Canceractive not recruitingn=960
  • phase3An Extension Study in Participants Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella C)active not recruitingn=49
  • phase2Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant Prostate Canceractive not recruitingn=15
  • phase3Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPCactive not recruitingn=1,054
  • phase3A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.recruitingn=900
  • phase2A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPCrecruitingn=123
  • phase2An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)active not recruitingn=168
  • phase2FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Canceractive not recruitingn=44

Patent cliff

source: FDA Orange Book
first barrier falls
Nov 17, 2026
47 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (17)

  • Feb 23, 2037method-of-use (U-4104)US 12161628
  • Feb 23, 2037method-of-use (U-4104)US 12161628
  • Feb 23, 2037method-of-use (U-4101)US 12161628
  • Sep 11, 2033formulationUS 11839689
  • Sep 11, 2033formulationUS 11839689
  • Sep 11, 2033method-of-use (U-4314)US 12447128
  • Sep 11, 2033method-of-use (U-4365)US 12502357
  • Sep 11, 2033method-of-use (U-4365)US 12502357
  • Aug 13, 2027compositionUS 7709517316d
  • Aug 13, 2027compositionUS 7709517316d
  • Aug 13, 2027compositionUS 7709517316d
  • Aug 24, 2026method-of-use (U-3763)US 8183274
  • Aug 24, 2026method-of-use (U-3763)US 8183274
  • Aug 24, 2026method-of-use (U-3763)US 8183274
  • May 15, 2026method-of-use (U-3763)US 9126941
  • May 15, 2026method-of-use (U-3763)US 9126941
  • May 15, 2026method-of-use (U-3763)US 9126941

FDA exclusivities (3)

  • Nov 17, 2026I-926Indication (3y)47d
  • Nov 17, 2026I-926Indication (3y)47d
  • Nov 17, 2026I-926Indication (3y)47d

News(3)

  • Earnings roundup: Gilead’s ‘uncertain’ future, Pfizer’s crossroads and Merck’s PCSK9 launch
    Some analysts see warning signs in crucial drug launches from Gilead and Merck, while an important trial readout could change Pfizer’s growth trajectory.
    biopharma_dive · 1mo ago
  • Alpha-Emitting Therapies in Metastatic Castration-Resistant Prostate Cancer
    Dr. Johann De Bono and Dr. Pedro Barata discuss the evolving role of alpha-emitting radiopharmaceutical therapies in metastatic castration-resistant prostate cancer (mCRPC), with a focus on radium…
    onclive · 4mo ago
  • GU Cancer Experts Highlight Top Abstracts to Watch During ASCO 2026
    We spoke with leading voices in GU oncology to see which presentations they are most looking forward to during the 2026 ASCO Annual Meeting.
    onclive · 4mo ago
brand
Xtandi
generic
enzalutamide
indication
Prostate Cancer
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 3h ago
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