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BAY86-5300
BAY86-5300 is a selective inhibitor of phosphoinositide 3-kinase (PI3K) that blocks PI3K signaling to suppress tumor cell proliferation and survival.
BAY86-5300 is a selective inhibitor of phosphoinositide 3-kinase (PI3K) that blocks PI3K signaling to suppress tumor cell proliferation and survival. Used for Advanced or metastatic solid tumors with PI3K pathway alterations.
At a glance
| Generic name | BAY86-5300 |
|---|---|
| Sponsor | Bayer |
| Drug class | PI3K inhibitor |
| Target | PI3K (phosphoinositide 3-kinase) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
PI3K is a key enzyme in cell survival and proliferation pathways frequently dysregulated in cancer. By selectively inhibiting PI3K, BAY86-5300 reduces phosphorylation of downstream effectors like AKT, leading to decreased cell survival signals and increased apoptosis in cancer cells. This mechanism is particularly relevant in tumors with PI3K pathway activation or loss of PTEN.
Approved indications
- Advanced or metastatic solid tumors with PI3K pathway alterations
Common side effects
- Hyperglycemia
- Diarrhea
- Rash
- Fatigue
Key clinical trials
- YAZ Post Authorization Safety Study (PASS)/Post Authorization Efficacy Study (PAES) in China (PHASE4)
- YAZ Post-marketing Surveillance in Japan
- Comparative Study of BAY86-5300 With an Extended Flexible Regimen for Endometriosis (PHASE3)
- To Investigate Efficacy of YAZ in the Treatment of Dysmenorrhea (PHASE3)
- Comparative Study of BAY86-5300 With a Flexible Extended Regimen for Dysmenorrhea (PHASE3)
- GA YAZ ACNE in China Phase III (PHASE3)
- Regulatory Post Marketing Surveillance Study on YAZ
- Efficacy and Safety Oral Contraceptive Study (PHASE3)
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:
- BAY86-5300 CI brief — competitive landscape report
- BAY86-5300 updates RSS · CI watch RSS
- Bayer portfolio CI