PI3Kalpha Inhibitors
1 drugsAbout PI3Kalpha
Phosphatidylinositol 3-kinase alpha (PI3Kalpha) is an intracellular signaling enzyme involved in cell growth, proliferation, survival, and metabolism. It phosphorylates phosphoinositides, lipids in the cell membrane, activating downstream signaling pathways. As a key regulator of cell function, PI3Kalpha has emerged as a drug development target, particularly in oncology.
Currently, there is no genetic evidence data available linking PI3Kalpha to specific diseases. However, its role in fundamental cellular processes makes it a compelling target for therapeutic intervention, especially in cancers driven by PI3K pathway activation.
There is one FDA-approved drug targeting PI3Kalpha: ITOVEBI (Roche), a small molecule approved in 2024 for oncology indications. Roche is the only company with an approved PI3Kalpha-targeting drug, marking an early stage in the target's drug development.
Strategic Insights
ℹ️ How we calculate- White space opportunity in Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer with only 1 trials.
Top Drugs
Roche is currently the only company with an approved drug targeting PI3Kalpha.
First-mover advantage for Roche creates a high barrier to entry, requiring differentiated clinical or commercial strategy.
Drug Modality Landscape
Modalities
Routes of Administration
Only one approved drug targets PI3Kalpha, using small molecule modality.
Explore opportunities for novel modalities like antibodies or PROTACs to differentiate from existing therapies.
Clinical Trials 42 trials
Completion by Phase
| Phase | Total | Completed | Failed | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 16 | 7 | 0 | 9 | 100% |
| Phase 2 | 18 | 3 | 2 | 13 | 60% |
| Phase 3 | 6 | 2 | 0 | 4 | 100% |
| Phase 4 | 2 | 1 | 1 | 0 | 50% |
Top Sponsors
By Modality
Top Conditions
Top Drugs
Phase 3 Readout Calendar Pro
1 Phase 3 trial testing approved PI3Kalpha drugs across all sponsors.
Coverage: trials whose intervention is an approved drug targeting PI3Kalpha. Pre-approval candidates with development codes (e.g. AZD0901, MK-7240) are not yet linked. Anchored on CT.gov primary completion date.
Drug Approval Timeline (2024 - 2024)
The first and only drug targeting PI3Kalpha, ITOVEBI, was approved in 2024.
Recent approval indicates growing interest, but also suggests potential for market saturation if new drugs follow quickly.
Pro Intelligence Preview
Deep insights for drug target analysis
Competitive Landscape
- • 1 companies competing
- • Market share by company
Full Drug Portfolio
- • All 1 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 1-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Competition: High (15 sponsors)
- • White space: 10 underexplored indications
- • Success rates by condition
Full summary • All drugs • Genetic evidence • Trials • Timeline
How We Calculate These Metrics
Target Attractiveness Score
A 0-100 score based on trial activity, sponsor diversity, and completion rates. Calculated from 34 clinical trials targeting PI3Kalpha.
Completion rate: Percentage of trials that reached their planned endpoint. Trials terminated early, withdrawn, or suspended are not counted—these often indicate safety issues, lack of efficacy, or strategic pivots.
- Highly Attractive (80+): High trial activity, many sponsors, strong completion rates
- Attractive (60-79): Good trial activity and validation
- Moderate (40-59): Moderate interest from sponsors
- Low (under 40): Limited trial activity or validation concerns
Strategic Insights
Auto-generated insights based on trial analytics including competition intensity, white space opportunities, modality shifts, and failure patterns. We analyze trial sponsors, phases, indications, and outcomes.
Risk Signals
- High Competition: Many sponsors competing for this target (may reduce market opportunity)
- High Failure Risk: Low trial completion rates suggest development challenges
- Low Validation: Limited trial activity or poor outcomes indicate uncertain viability
- White Space Available: Underexplored indications present opportunities