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Azd5363 (azd5363)
AZD5363, developed by Pfizer Inc., is an anti-cancer medication used for the treatment of triple-negative breast cancer and urothelial carcinoma. It is taken by mouth. The drug has shown clinical differentiation in its ability to target specific molecular pathways. AZD5363 has significant commercial importance due to its potential to address unmet medical needs. The drug's mechanism of action involves targeting the AKT pathway. Further pipeline developments are needed to fully realize its potential. AZD5363 has shown promise in clinical trials, with 38 trials conducted and 148 publications.
At a glance
| Generic name | azd5363 |
|---|---|
| Sponsor | Pfizer |
| Drug class | phosphatidylinositol 3-kinase (PI3K) inhibitor |
| Target | AKT |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- Triple-negative breast cancer
- Advanced or metastatic urothelial carcinoma
- Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy
- Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy
- Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy
- Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy
- Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib
- Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib
- Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab
- Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab and in patients who are not eligible for nivolumab plus ipilimumab
- Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab and in patients who are not eligible for nivolumab plus ipilimumab and in patients who are not eligible for pembrolizumab plus lenvatinib
- Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab and in patients who are not eligible for nivolumab plus ipilimumab and in patients who are not eligible for pembrolizumab plus lenvatinib and in patients who are not eligible for avelumab plus alpelisib
- Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab and in patients who are not eligible for nivolumab plus ipilimumab and in patients who are not eligible for pembrolizumab plus lenvatinib and in patients who are not eligible for avelumab plus alpelisib and in patients who are not eligible for pembrolizumab plus axicabtagene ciloleucel
- Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab and in patients who are not eligible for nivolumab plus ipilimumab and in patients who are not eligible for pembrolizumab plus lenvatinib and in patients who are not eligible for avelumab plus alpelisib and in patients who are not eligible for pembrolizumab plus axicabtagene ciloleucel and in patients who are not eligible for pembrolizumab plus sacituzumab govitecan
- Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab and in patients who are not eligible for nivolumab plus ipilimumab and in patients who are not eligible for pembrolizumab plus lenvatinib and in patients who are not eligible for avelumab plus alpelisib and in patients who are not eligible for pembrolizumab plus axicabtagene ciloleucel and in patients who are not eligible for pembrolizumab plus sacituzumab govitecan and in patients who are not eligible for pembrolizumab plus atezolizumab
- Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab and in patients who are not eligible for nivolumab plus ipilimumab and in patients who are not eligible for pembrolizumab plus lenvatinib and in patients who are not eligible for avelumab plus alpelisib and in patients who are not eligible for pembrolizumab plus axicabtagene ciloleucel and in patients who are not eligible for pembrolizumab plus sacituzumab govitecan and in patients who are not eligible for pembrolizumab plus atezolizumab and in patients who are not eligible for pembrolizumab plus nivolumab
- Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab and in patients who are not eligible for nivolumab plus ipilimumab and in patients who are not eligible for pembrolizumab plus lenvatinib and in patients who are not eligible for avelumab plus alpelisib and in patients who are not eligible for pembrolizumab plus axicabtagene ciloleucel and in patients who are not eligible for pembrolizumab plus sacituzumab govitecan and in patients who are not eligible for pembrolizumab plus atezolizumab and in patients who are not eligible for pembrolizumab plus nivolumab and in patients who are not eligible for pembrolizumab plus avelumab
- Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab and in patients who are not eligible for nivolumab plus ipilimumab and in patients who are not eligible for pembrolizumab plus lenvatinib and in patients who are not eligible for avelumab plus alpelisib and in patients who are not eligible for pembrolizumab plus axicabtagene ciloleucel and in patients who are not eligible for pembrolizumab plus sacituzumab govitecan and in patients who are not eligible for pembrolizumab plus atezolizumab and in patients who are not eligible for pembrolizumab plus nivolumab and in patients who are not eligible for pembrolizumab plus avelumab and in patients who are not eligible for pembrolizumab plus durvalumab
- Advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy and at least one other systemic therapy and in patients who are not eligible for platinum-containing chemotherapy and in patients who are not eligible for atezolizumab plus platinum-containing chemotherapy and in patients who are not eligible for pembrolizumab plus axitinib and in patients who are not eligible for avelumab plus axitinib and in patients who are not eligible for durvalumab plus tremelimumab and in patients who are not eligible for nivolumab plus ipilimumab and in patients who are not eligible for pembrolizumab plus lenvatinib and in patients who are not eligible for avelumab plus alpelisib and in patients who are not eligible for pembrolizumab plus axicabtagene ciloleucel and in patients who are not eligible for pembrolizumab plus sacituzumab govitecan and in patients who are not eligible for pembrolizumab plus atezolizumab and in patients who are not eligible for pembrolizumab plus nivolumab and in patients who are not eligible for pembrolizumab plus avelumab and in patients who are not eligible for pembrolizumab plus durvalumab and in patients who are not eligible for pembrolizumab plus sacituzumab govitecan plus cetrelimab
- Triple-negative breast cancer with disease progression on or after chemotherapy in the neoadjuvant or adjuvant setting and/or in patients with measurable disease by RECIST v1.1
Common side effects
Drug interactions
- CYP3A4 inhibitors
- CYP3A4 inducers
- Strong CYP3A4 inhibitors
- Strong CYP3A4 inducers
- CYP2C9 inhibitors
- CYP2C9 inducers
- CYP2C19 inhibitors
- CYP2C19 inducers
- CYP2D6 inhibitors
- CYP2D6 inducers
- P-gp inhibitors
- P-gp inducers
Key clinical trials
- Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients (PHASE3)
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (PHASE2)
- IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors (PHASE1)
- Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone (PHASE2)
- Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas (PHASE2)
- A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Rosuvastatin in Healthy Participants (PHASE1)
- AMTEC IIT: Phase 2 Multiarm Study in TNBC (PHASE2)
- A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Azd5363 CI brief — competitive landscape report
- Azd5363 updates RSS · CI watch RSS
- Pfizer portfolio CI