PI3K-delta Inhibitors
2 drugsAbout PI3K-delta
PI3K-delta is an intracellular signaling enzyme involved in cell growth, proliferation, survival, and immune cell function. It phosphorylates phosphatidylinositol lipids, initiating downstream signaling cascades that regulate these processes. As a member of the PI3K family, it plays a crucial role in various cellular activities.
Currently, there is no genetic evidence directly linking PI3K-delta to specific diseases. However, its involvement in fundamental cellular processes makes it a valuable target for therapeutic intervention, particularly in oncology and other immune-related disorders.
PI3K-delta is targeted by two FDA-approved small molecule drugs: COPIKTRA (SECURA) and JOENJA (PHARMING). COPIKTRA is used in oncology, while JOENJA is used in other therapeutic areas, highlighting the target's potential across different indications.
Strategic Insights
ℹ️ How we calculate- White space opportunity in Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8 with only 1 trials.
- phase3 represents biological uncertainty with 0% completion.
Top Drugs
The competitive landscape consists of two companies, SECURA and PHARMING, with approved drugs targeting PI3K-delta.
Low market concentration suggests relatively low barriers to entry for new companies targeting PI3K-delta.
Drug Modality Landscape
Modalities
Routes of Administration
PI3K-delta is amenable to small molecule drugs, with oral options available for convenient dosing.
The exclusive use of small molecules presents an opportunity to explore other modalities like antibodies or PROTACs.
Clinical Trials 66 trials
Completion by Phase
| Phase | Total | Completed | Failed | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 29 | 12 | 9 | 8 | 57% |
| Phase 2 | 23 | 12 | 3 | 7 | 80% |
| Phase 3 | 11 | 5 | 2 | 4 | 71% |
| Phase 4 | 3 | 2 | 1 | 0 | 67% |
Top Sponsors
By Modality
Phase 3 Readout Calendar Pro
1 Phase 3 trial testing approved PI3K-delta drugs across all sponsors.
Coverage: trials whose intervention is an approved drug targeting PI3K-delta. 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 (2018 - 2023)
The first drug targeting PI3K-delta was approved in 2018 (COPIKTRA), with the most recent approval in 2023 (JOENJA).
Recent approval indicates continued interest, but a 6-year span suggests potential saturation or challenges in development.
Pro Intelligence Preview
Deep insights for drug target analysis
Competitive Landscape
- • 2 companies competing
- • Market share by company
Full Drug Portfolio
- • All 2 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 2-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 46 clinical trials targeting PI3K-delta.
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