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

patents (14)

Apr 16, 2033method-of-use (U-3762)US 10039766
Apr 16, 2033method-of-use (U-3762)US 10039766
Apr 16, 2033compositionUS 9487525
Apr 16, 2033compositionUS 9487525
Mar 10, 2030compositionUS 81016233.6y
Mar 10, 2030compositionUS 81016233.6y
Oct 10, 2028compositionUS 100597142.2y
Oct 10, 2028compositionUS 100597142.2y
Oct 10, 2028method-of-use (U-3762)US 106548552.2y
Oct 10, 2028method-of-use (U-3762)US 106548552.2y
Oct 10, 2028method-of-use (U-3762)US 117607602.2y
Oct 10, 2028method-of-use (U-3762)US 117607602.2y
Oct 10, 2028method-of-use (U-3762)US 122524952.2y
Oct 10, 2028method-of-use (U-3762)US 122524952.2y

FDA exclusivities (2)

Nov 16, 2028NCENew Chemical Entity (5y)2.3y
Nov 16, 2028NCENew Chemical Entity (5y)2.3y

News(5)

Vaderis hauls in $152M to test an AKT-targeting drug
The startup is one of at least a few young companies zeroing in on the rare bleeding disorder, hereditary hemorrhagic telangiectasia, with a more precise AKT blocker.
biopharma_dive · 3d ago
‘Unlikely’ AstraZeneca-BMS mega-merger would be largest pharma deal ever
If AstraZeneca and Bristol Myers Squibb were to successfully become one company, analysts say it could reset the current deal environment, which has picked up greatly in the first half of the year.
biospace · 11d ago
Celcuity breast cancer drug misses ‘lofty’ expectations in ASCO-spotlighted trial
Gedatolisib could “establish a new standard of care” for PIK3CA-mutated breast cancer, an investigator said, but the results nonetheless appeared to disappoint investors.
biopharma_dive · 2mo ago
Capivasertib/Fulvestrant Yields Numerical OS Advantage in PIK3CA/AKT1/PTEN–Altered Breast Cancer
Capivasertib plus fulvestrant generated a numerical OS benefit vs placebo plus fulvestrant in PIK3CA/AKT1/PTEN-altered advanced breast cancer.
onclive · 3mo ago
Celcuity strengthens case for ASCO-spotlighted breast cancer drug
The new data could support a broader approval submission for a therapy that is already under review and set to be showcased at the year’s biggest meeting for cancer research.
biopharma_dive · 3mo ago

Data sources

openFDA · ClinicalTrials.gov · OpenTargets

last refreshed 36m ago

Found something off?

comments(0)

5-min edit window · permanent after that

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drug · small molecule

save

capivasertib

Marketedupdated 3mo ago

by $AZN ASTRAZENECA PLC🔗 ChEMBL

Approved

community read0 votes

🐶 often sniffed alongside

top 7

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 3 approved and 7 investigational indications.

targets

Serine/threonine-protein kinase AKT

all catalysts(5)

approval · 4

TRUQAP (CAPIVASERTIB) — FDA approval

TRUQAP (CAPIVASERTIB) — FDA approval

TRUQAP (CAPIVASERTIB) — FDA approval

TRUQAP (CAPIVASERTIB) — FDA approval

capivasertib

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fda advisory committee meeting · 1

Apr 30, 2026

fda advisory committee meeting

$AZN156.45-0.50%

4mo ago

AstraZeneca Plc — capivasertib (FDA Advisory Committee Meeting)

capivasertib

→

Trials studying capivasertib

phase2Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancerrecruitingn=315
phase1A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Canceractive not recruitingn=138
phase3Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancerrecruitingn=540
phase2Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Canceractive not recruitingn=435
phase2Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumorsrecruitingn=92
phase2A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Canceractive not recruitingn=243
phase3Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)recruitingn=895
phase1A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Dextromethorphan (CYP2D6 Substrate) in Healthy Participantsrecruitingn=42

more trials →

Patent cliff

source: FDA Orange Book

first barrier falls

Oct 10, 2028

~2.2 years out

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

patents (14)

Apr 16, 2033method-of-use (U-3762)US 10039766
Apr 16, 2033method-of-use (U-3762)US 10039766
Apr 16, 2033compositionUS 9487525
Apr 16, 2033compositionUS 9487525
Mar 10, 2030compositionUS 81016233.6y
Mar 10, 2030compositionUS 81016233.6y
Oct 10, 2028compositionUS 100597142.2y
Oct 10, 2028compositionUS 100597142.2y
Oct 10, 2028method-of-use (U-3762)US 106548552.2y
Oct 10, 2028method-of-use (U-3762)US 106548552.2y
Oct 10, 2028method-of-use (U-3762)US 117607602.2y
Oct 10, 2028method-of-use (U-3762)US 117607602.2y
Oct 10, 2028method-of-use (U-3762)US 122524952.2y
Oct 10, 2028method-of-use (U-3762)US 122524952.2y

FDA exclusivities (2)

Nov 16, 2028NCENew Chemical Entity (5y)2.3y
Nov 16, 2028NCENew Chemical Entity (5y)2.3y

News(5)

Vaderis hauls in $152M to test an AKT-targeting drug
The startup is one of at least a few young companies zeroing in on the rare bleeding disorder, hereditary hemorrhagic telangiectasia, with a more precise AKT blocker.
biopharma_dive · 3d ago
‘Unlikely’ AstraZeneca-BMS mega-merger would be largest pharma deal ever
If AstraZeneca and Bristol Myers Squibb were to successfully become one company, analysts say it could reset the current deal environment, which has picked up greatly in the first half of the year.
biospace · 11d ago
Celcuity breast cancer drug misses ‘lofty’ expectations in ASCO-spotlighted trial
Gedatolisib could “establish a new standard of care” for PIK3CA-mutated breast cancer, an investigator said, but the results nonetheless appeared to disappoint investors.
biopharma_dive · 2mo ago
Capivasertib/Fulvestrant Yields Numerical OS Advantage in PIK3CA/AKT1/PTEN–Altered Breast Cancer
Capivasertib plus fulvestrant generated a numerical OS benefit vs placebo plus fulvestrant in PIK3CA/AKT1/PTEN-altered advanced breast cancer.
onclive · 3mo ago
Celcuity strengthens case for ASCO-spotlighted breast cancer drug
The new data could support a broader approval submission for a therapy that is already under review and set to be showcased at the year’s biggest meeting for cancer research.
biopharma_dive · 3mo ago

Data sources

openFDA · ClinicalTrials.gov · OpenTargets

last refreshed 36m ago

Found something off?

comments(0)

5-min edit window · permanent after that

no comments yet — first sniff?

capivasertib

🐶 often sniffed alongside

targets

all catalysts(5)

Trials studying capivasertib

Patent cliff

patents (14)

FDA exclusivities (2)

News(5)

Report a data issue

comments(0)

capivasertib

🐶 often sniffed alongside

targets

all catalysts(5)

Trials studying capivasertib

Patent cliff

patents (14)

FDA exclusivities (2)

News(5)

Report a data issue

comments(0)