Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CAL-101 · 2 trials · 5 indications
| Arm | Type | Description |
|---|---|---|
| CAL-101 | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| one arm | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| CAL-101 | DRUG | CAL-101 100mg capsules administered orally twice a day (BID) for 7 days |
| Placebo | DRUG | Placebo capsules administered orally BID for 7 days |
Inclusion Criteria: 1. Age \> or = 18 and \< or = 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 (\> or = class 2) for grass polle...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150, Standard therapy for INCS |
| Polyrizon Ltd. | PLRZ | 1 | N/A | Undisclosed |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | - | Undisclosed |
CAL-101 is an investigational small molecule being studied for Chronic Lymphocytic Leukemia (CLL), allergic rhinitis, and other conditions. In clinical trials, it has been evaluated in patients with relapsed or refractory hematologic malignancies, including CLL, lymphoma, acute myeloid leukemia, and multiple myeloma, as well as in subjects with allergic rhinitis.
CAL-101 is being developed by Gilead Sciences, Inc. (NASDAQ: GILD). The company has conducted clinical trials of CAL-101 in the United States and Austria.
CAL-101 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in hematologic malignancies and one in allergic rhinitis. CAL-101 is investigational and has not been approved by the FDA.
CAL-101 has been studied in two completed Phase 1 trials. NCT00710528 was a dose escalation study in relapsed or refractory hematologic malignancies with 192 participants. NCT00836914 investigated CAL-101 in subjects with allergic rhinitis exposed to allergen in an environmental chamber, with 41 participants.
CAL-101 is also known as idelalisib. It is a small molecule being developed by Gilead Sciences. In clinical trials, it has been studied for conditions such as Chronic Lymphocytic Leukemia and allergic rhinitis.