Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ruxolitinib IR · 2 trials · 1 indication
INCB018424 concentration in plasma.
| Arm | Type | Description |
|---|---|---|
| Period 1: Dose Treatment A | EXPERIMENTAL | Ruxolitinib IR will be administered at protocol defined dose. |
| Period 1: Dose Treatment B | EXPERIMENTAL | Ruxolitinib XR will be administered at protocol defined dose. |
| Period 2: Dose Treatment A | EXPERIMENTAL | Ruxolitinib IR will be administered at protocol defined dose. |
| Period 2: Dose Treatment B | EXPERIMENTAL | Ruxolitinib XR will be administered at protocol defined dose. |
| Cohort 1: Dose Treatment A | EXPERIMENTAL | Ruxolitinib IR will be administered at protocol defined dose. |
| Cohort 1: Dose Treatment B | EXPERIMENTAL | Ruxolitinib XR will be administered at protocol defined dose. |
| Cohort 2: Dose Treatment A | EXPERIMENTAL | Ruxolitinib IR will be administered at protocol defined dose. |
| Cohort 2: Dose Treatment B | EXPERIMENTAL | Ruxolitinib XR will be administered at protocol defined dose. |
| Name | Type | Description |
|---|---|---|
| Ruxolitinib IR | DRUG | Tablet |
| Ruxolitinib XR | DRUG | Tablet |
Inclusion Criteria: * Ability to comprehend and willingness to sign a written ICF for the study. * Healthy adult participants aged 18 to 55 years, inclusive at screening. * Body mass index between 18.0 and 32.0 kg/m2, inclusive, at screening. Note: Only up to 25% of the participants may be enrolled...
Ruxolitinib IR is an immediate release formulation of ruxolitinib being studied in healthy participants. It is currently in Phase 1 clinical development and is not approved for any indication. The studies evaluate its relative bioavailability and bioequivalence compared with a ruxolitinib extended release tablet.
Ruxolitinib IR is being developed by Incyte Corporation, which trades under the ticker INCY. The company is conducting Phase 1 clinical trials to evaluate the pharmacokinetics of this immediate release formulation in healthy participants.
Ruxolitinib IR is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both involving healthy participants, with no active trials currently ongoing.
Ruxolitinib IR has two completed Phase 1 trials: NCT06310304, which evaluated relative bioavailability of extended release versus immediate release tablets in 24 healthy participants, and NCT06555081, which assessed bioequivalence in 168 healthy participants. Both were conducted in the United States.
Ruxolitinib IR is the immediate release formulation, while Ruxolitinib XR is the extended release formulation. They are different versions of the same drug, ruxolitinib, and the clinical trials are designed to compare their bioavailability and bioequivalence when administered orally.