> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/capivasertib-935ebe6a-a1c8-413b-8259-07e301a25a61
> Record changed: 2026-10-13

# Capivasertib

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2325741)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2325741)

First approval year

2023

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2325741)

## Development status

**First approval year**

2023

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2325741)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2325741)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2325741)

**Drug name**

Capivasertib

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2325741)

**Molecular weight**

428.92

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2325741)

**Structure (SMILES)**

NC1(C(=O)N\[C@@H\](CCO)c2ccc(Cl)cc2)CCN(c2nc\[nH\]c3nccc2-3)CC1

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2325741)

### Brand names (2)

- truqap
- Truqap

### Other names (28)

- \[14C\]AZD5363 (Capivasertib)
- 14c azd5363 capivasertib
- azc5363
- AZC5363
- azd 5363
- Azd 5363
- AZD 5363
- Azd-5363
- AZD-5363
- azd5363
- AZD5363
- capivasertib
- Capivasertib
- CAPIVASERTIB
- CAPIVASERTIB (AZD5363)
- capivasertib \[INN\]
- CAPIVASERTIB \[JAN\]
- Capivasertib \[MI\]
- CAPIVASERTIB \[USAN\]
- Capivasertib \[WHO-DD\]
- capivasertib azd5363
- capivasertib inn
- capivasertib jan
- capivasertib mi
- capivasertib usan

And 3 more, listed on the interactive page.

## Identifiers

**ATC classification codes**

- L01EX27

Sources for recorded values

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2325741)

**CAS registry numbers**

- 1143532-39-1

**ChEMBL ID**

CHEMBL2325741

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2325741)

**InChIKey**

JDUBGYFRJFOXQC-KRWDZBQOSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2325741)

**PubChem compound IDs**

- 25227436

**RxNorm IDs (RxCUI)**

- 2669967

**FDA ingredient codes (UNII)**

- WFR23M21IE

## Regulatory information

### United States

**Applicant**

ASTRAZENECA

**Approval date**

16 Nov 2023

**Application number**

NDA218197

### European Union

**Status**

Authorised

**Status date**

17 Jun 2024

**Authorisation date**

17 Jun 2024

**Approved indications**

Truqap is indicated in combination with fulvestrant for the treatment of adult patients with oestrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following recurrence or progression on or after an endocrine-based regimen. In pre- or perimenopausal women, Truqap plus fulvestrant should be combined with a luteinising hormone releasing hormone (LHRH) agonist. For men, administration of LHRH agonist according to current clinical practice standards should be considered.

**Product number**

EMEA/H/C/006017

**Authorisation holder**

AstraZeneca AB

**Priority medicines scheme**

No

**Generic**

No

**Biosimilar**

No

**Generic medicines**

0

**Biosimilar medicines**

0

**Advanced therapy**

No

**Conditional approval**

No

**Additional monitoring**

Yes

**Accelerated assessment**

No

**Exceptional circumstances**

No

#### Therapeutic areas

- Breast Neoplasms

European medicines record

Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/truqap)

### Other regulatory facts

**Patents**

7

**Designations**

2

**Earliest recorded loss of exclusivity**

16 Apr 2033

**First in class**

Yes

**Fast track**

Yes

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

Yes

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

**Pharmacology name**

capivasertib

**Type**

Synthetic organic

**Drug name stem**

\-sertib

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Oral

### Mechanisms of action (6)

- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
AKT serine/threonine kinase 1

**Gene symbol**  
AKT1

**Protein identifier**  
P31749

**Median affinity**

8.52

**Affinity units**  
pIC50

**Primary target**  
Yes
- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
AKT serine/threonine kinase 2

**Gene symbol**  
AKT2

**Protein identifier**  
P31751

**Median affinity**

8.1

**Affinity units**  
pIC50

**Primary target**  
Yes
- **Action**  
Inhibition

**Action type**  
Inhibitor

**Target**  
AKT serine/threonine kinase 3

**Gene symbol**  
AKT3

**Protein identifier**  
Q9Y243

**Median affinity**

8.1

**Affinity units**  
pIC50

**Primary target**  
Yes
- **Mechanism**  
Serine/threonine-protein kinase AKT inhibitor

**Action type**  
Inhibitor

**Target**  
Serine/threonine-protein kinase AKT

**Protein identifier**  
P31749
- **Mechanism**  
Serine/threonine-protein kinase AKT inhibitor

**Action type**  
Inhibitor

**Target**  
Serine/threonine-protein kinase AKT

**Protein identifier**  
P31751
- **Mechanism**  
Serine/threonine-protein kinase AKT inhibitor

**Action type**  
Inhibitor

**Target**  
Serine/threonine-protein kinase AKT

**Protein identifier**  
Q9Y243

### Open Targets mechanisms

- **Mechanism**  
Serine/threonine-protein kinase AKT inhibitor

**Action type**  
Inhibitor

**Target**  
Serine/threonine-protein kinase AKT

### Investigated indications (19)

- **Condition**  
Lymphoma, Follicular

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000096

**Subject identifier**  
D008224
- **Condition**  
Adenocarcinoma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000228

**Subject identifier**  
D000230
- **Condition**  
Stomach Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000503

**Subject identifier**  
D013274
- **Condition**  
Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0000616

**Subject identifier**  
D009369
- **Condition**  
Prostatic Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000673

**Subject identifier**  
D011471
- **Condition**  
Carcinoma, Squamous Cell

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0000707

**Subject identifier**  
D002294
- **Condition**  
Multiple Myeloma

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0001378

**Subject identifier**  
D009101
- **Condition**  
Hematologic Neoplasms

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0001642

**Subject identifier**  
D019337
- **Condition**  
Carcinoma, Non-Small-Cell Lung

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0003060

**Subject identifier**  
D002289
- **Condition**  
Uterine Neoplasms

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0003859

**Subject identifier**  
D014594
- **Condition**  
Breast Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
EFO:0003869

**Subject identifier**  
D001943
- **Condition**  
Triple Negative Breast Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
EFO:0005537

**Subject identifier**  
D064726
- **Condition**  
Stomach Neoplasms

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0001056

**Subject identifier**  
D013274
- **Condition**  
Uterine Cervical Neoplasms

**Highest recorded phase**  
1

**Condition identifier**  
MONDO:0002974

**Subject identifier**  
D002583
- **Condition**  
Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
MONDO:0004992

**Subject identifier**  
D009369
- **Condition**  
Breast Neoplasms

**Highest recorded phase**  
4

**Condition identifier**  
MONDO:0007254

**Subject identifier**  
D001943
- **Condition**  
Prostatic Neoplasms, Castration-Resistant

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0008315

**Subject identifier**  
D064129
- **Condition**  
Meningioma

**Highest recorded phase**  
2

**Condition identifier**  
MONDO:0850302

**Subject identifier**  
D008579
- **Condition**  
Hereditary Breast and Ovarian Cancer Syndrome

**Highest recorded phase**  
1

**Condition identifier**  
Orphanet:145

**Subject identifier**  
D061325

### Open Targets indications (29)

- **Condition identifier**  
EFO\_0000096

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0000616
- **Condition identifier**  
EFO\_0000673

**Highest recorded phase**  
2
- **Condition identifier**  
EFO\_0001642

**Highest recorded phase**  
1
- **Condition identifier**  
EFO\_0003869
- **Condition identifier**  
EFO\_0005537

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0000873

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0001416

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0002974

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0004967

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0004992

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005036

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005062

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005070

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0005233

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0005494

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0007254
- **Condition identifier**  
MONDO\_0007254

**Highest recorded phase**  
4
- **Condition identifier**  
MONDO\_0008170

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0008315

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0009693

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0011962

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0016642

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0017604

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0018876

**Highest recorded phase**  
2

And 4 more, listed on the interactive page.

### Reported adverse events

- **Event**  
hyperglycaemia

**Reports**  
3

**Reporting signal score**

9.01811

### Trial references (34)

- NCT01226316  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01226316)
- NCT01353781  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01353781)
- NCT01895946  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01895946)
- NCT02338622  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02338622)
- NCT02576444  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02576444)
- NCT03772561  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03772561)
- NCT04742036  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04742036)
- NCT04958226  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04958226)
- NCT01625286  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01625286)
- NCT01992952  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01992952)
- NCT02077569  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02077569)
- NCT02299999  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02299999)
- NCT03182634  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03182634)
- NCT04305496  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04305496)
- NCT04862663  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04862663)
- NCT01692262  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01692262)
- NCT02121639  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02121639)
- NCT04087174  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04087174)
- NCT04493853  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04493853)
- NCT05348577  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05348577)
- NCT05593497  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05593497)
- NCT02117167  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02117167)
- NCT02664935  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02664935)
- NCT02208375  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02208375)
- NCT03801369  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03801369)

And 9 more, listed on the interactive page.

## Dosing

**Dose**

400 mg

**Route**

Oral

**How often**

Twice daily for 4 days followed by 3 days off

### Conditions of use

- Take with or without food

## Chemical properties

**Hydrogen bond acceptors**

6

**Hydrogen bond donors**

4

**Polar surface area**

120.16

**Calculated partition coefficient (ALogP)**

2.1

**Calculated partition coefficient (XLogP)**

1.7

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Rule-of-five violations**

0

**Rotatable bonds**

6

**Heavy atoms**

30

**Molecular formula**

C21H25ClN6O2

**Monoisotopic mass**

428.1727518

**Natural product**

Yes

## National Drug Codes

- 0310-9500
- 0310-9501

## Evidence counts

**Recorded assays**

1,025

**Active assays**

241

### Active assay types (3)

- Confirmatory
- Other
- Screening

## Pharmacologic actions

- Antineoplastic Agents  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000970.html)
- Protein Kinase Inhibitors  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D047428.html)

## Biological measurements

These details could not be displayed.

## Related records

### Trials (62)

- A Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of Capivasertib (AZD5363) in Combination With Novel Agents in Patients With Metastatic Prostate Cancer
- A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer
- A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment
- A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain
- A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss
- A Study of Enzalutamide in Combination With AZD5363 in Patients With mCRPC
- A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer
- A Study to Assess How Itraconazole Affects the Uptake and Elimination of Capivasertib in the Body
- A Study to Assess the Effect of Capivasertib on Midazolam in Patients With Advanced Solid Tumours
- A Study to Investigate the Absolute Bioavailability, Absorption, Metabolism, Distribution and Excretion of \[14C\]AZD5363 (Capivasertib)
- A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Dextromethorphan (CYP2D6 Substrate) in Healthy Participants
- A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Rosuvastatin in Healthy Participants
- AKT Inhibitor in Oestrogen Positive Breast Cancer
- AMTEC IIT: Phase 2 Multiarm Study in TNBC
- AZD5363 in Patients With Advanced Solid Tumors Harboring AKT Mutations
- Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)
- Capivasertib China PK Study
- Capivasertib Plus Fulvestrant vs. Fulvestrant in Primary High-risk Lobular Breast Cancer
- CApivasertib, Venetoclax And Low-intensity chemotheRapY for Adults With ALL/LBL
- Capivasertib+Abiraterone as Treatment for Patients With Metastatic Hormone-sensitive Prostate Cancer and PTEN Deficiency

### Approved for (4)

- [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md)
- [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md)
- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md)
- Neoplasm

### In development for (15)

- [Adenocarcinoma](https://trialight.com/data/condition/adenocarcinoma-b5c321d1-7c49-5bf9-abd0-dfa99dbd5f29.md) Phase 2
- [Cervical cancer](https://trialight.com/data/condition/cervical-cancer-10fb8f6c-5aac-5281-8f06-7238adeec443.md) Phase 1
- [Gastric adenocarcinoma](https://trialight.com/data/condition/gastric-adenocarcinoma-6bb74a55-7ba6-53e3-a113-22296a84d6ae.md) Phase 2
- [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) Phase 2
- Hereditary breast ovarian cancer syndrome Phase 1
- Intracranial meningioma Phase 2
- Lymphoid neoplasm Phase 1
- Neoplasm of mature B-cells Phase 2
- [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Phase 2
- [Plasma cell myeloma](https://trialight.com/data/condition/plasma-cell-myeloma-37186689-2591-5775-9042-2f2bf046a2b5.md) Phase 2
- [Prostate adenocarcinoma](https://trialight.com/data/condition/prostate-adenocarcinoma-84e3e3af-1ae1-5760-8157-8d9fc0cff608.md) Phase 2
- [Prostate cancer](https://trialight.com/data/condition/prostate-cancer-3659fc70-617b-5868-a093-ae819ffc6755.md) Phase 3
- [Squamous cell carcinoma](https://trialight.com/data/condition/squamous-cell-carcinoma-44944de3-3c1f-5714-9da2-a28db7d896c2.md) Phase 2
- [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) Phase 2
- [Tumor of uterus](https://trialight.com/data/condition/tumor-of-uterus-0e35fef4-f54a-5086-aa67-9cd577110fd7.md) Phase 1

### Targets (3)

- [AKT1](https://trialight.com/data/target/akt1-ee1ed739-5355-5e13-89ff-29c18f0d904d.md) Serine/threonine-protein kinase AKT inhibitor
- [AKT2](https://trialight.com/data/target/akt2-672212dc-1224-540d-85af-2e61b6ce7cf1.md) Serine/threonine-protein kinase AKT inhibitor
- [AKT3](https://trialight.com/data/target/akt3-e83fd71b-7a8b-5c2d-b511-96cdd2ed530e.md) Serine/threonine-protein kinase AKT inhibitor

---

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