Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CAL-263 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | CAL-263 |
| 2 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| CAL-263 | DRUG | CAL-263 10 mg or placebo once daily for 7 days |
| Placebo | DRUG | CAL-263 10 mg or placebo once daily for 7 days |
Inclusion Criteria: 1. Age \>18 and \<55 years 2. Has a history of seasonal allergic rhinitis for at least 2 years 3. Has sensitivity to grass pollen demonstrated by a positive response to skin prick testing 4. Has a positive Radio Allergen Sorbent Test (class 2 or greater) for grass pollen during ...
Top 1 of 3 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150 |
CAL-263 is an investigational small molecule being studied for allergic rhinitis, a respiratory condition. It was tested in a Phase 1 environmental chamber study in which participants with allergic rhinitis were exposed to allergen. CAL-263 has not been approved for any use and remains in clinical development.
CAL-263 targets PIK3CD and PIK3CG, two phosphoinositide 3-kinase isoforms. It acts as an inhibitor of these targets. This mechanism was the basis for studying the compound in allergic rhinitis, where PI3K signaling is relevant to immune cell activation.
CAL-263 is being developed by Gilead Sciences, Inc., which trades on Nasdaq under the ticker GILD. Gilead is the sponsor associated with the clinical program for this compound in allergic rhinitis.
CAL-263 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 program evaluated the compound in patients with allergic rhinitis rather than healthy volunteers.
CAL-263 has been studied in one clinical trial, NCT01066611, titled a study to investigate effects of CAL-263 in subjects with allergic rhinitis exposed to allergen in an environmental chamber. The trial was Phase 1, completed, enrolled 48 participants, was randomized, double blind, and placebo controlled, and was conducted in Austria.