PI3Kdelta Inhibitors
4 drugsAbout PI3Kdelta
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.
Top PI3Kdelta 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 | Company | Approved | Indications |
|---|---|---|---|
| IDELALISIB | NATCO | 2026 | 3 |
PI3Kdelta Drug Modality Landscape
Modalities
Routes of Administration
PI3Kdelta 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.
PI3Kdelta Clinical Trials 99 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on PI3Kdelta. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 40 | 13 | 19 | 8 | 41% |
| Phase 2 | 37 | 18 | 13 | 6 | 58% |
| Phase 3 | 20 | 3 | 10 | 7 | 23% |
| Phase 4 | 2 | 0 | 1 | 1 | 0% |
Top Sponsors
By Modality
Top Conditions
Top Drugs
Phase 3 Readout Calendar Pro
3 Phase 3 trials testing approved PI3Kdelta drugs across all sponsors.
Coverage: trials whose intervention is an approved drug targeting PI3Kdelta. Pre-approval candidates with development codes (e.g. AZD0901, MK-7240) are not yet linked. Anchored on CT.gov primary completion date.
PI3Kdelta Drug Approval Timeline (2014 - 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.
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Competitive Landscape
- • 4 companies competing
- • Market share by company
Full Drug Portfolio
- • All 4 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 4-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 42 (14 companies)
- • Completion rates by condition
Full summary • All drugs • Genetic evidence • Trials • Timeline
How We Count Trials
- Trials: phase 1-4 interventional trials on ClinicalTrials.gov that started in 2008 or later and test an FDA-approved drug acting on PI3Kdelta. A trial counts if an approved drug acting on PI3Kdelta is in any arm, including as a comparator, and a trial that tests two such drugs counts once. Trials that test only unapproved drugs are not counted. A trial listed as phase 1/2 counts as phase 1, and phase 2/3 as phase 2.
- Active: recruiting, not yet recruiting, enrolling by invitation, or active and no longer recruiting.
- Completion rate: of the trials that have ended, the share marked Completed rather than Terminated or Withdrawn. Completed means the trial ended as planned; it does not mean the drug worked. Suspended trials are not counted as ended.
- Stopped: terminated or withdrawn. Trials stop for many reasons, including slow enrolment and business decisions, not only safety or efficacy.
- Sponsors: the lead sponsor of each trial. Companies are the sponsors ClinicalTrials.gov classes as industry; the rest are universities, hospitals, cooperative groups, government bodies and individuals.