Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fevipiprant · 2 trials · 2 indications
Nasal Polyp Score (NPS) is the sum of the right and left nostril scores, as evaluated by means of nasal endoscopy. Total score ranges from 0 to 8 (scored 0 \[no polyp\] to 4 \[large polyps\] for each nostril), with a lower score indicating smaller-sized polyps. Baseline NPS is defined as the last measurement performed on or before the date of randomization. A negative change from baseline in NPS is considered a favorable outcome.
AUClast is the area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration
AUCinf is the area under the plasma concentration-time curve from time zero to infinity
Cmax is the observed maximum plasma concentration following drug administration
| Arm | Type | Description |
|---|---|---|
| Fevipiprant 150 mg | EXPERIMENTAL | Fevipiprant (QAW039) 150 mg once daily orally |
| Fevipiprant 450 mg | EXPERIMENTAL | Fevipiprant (QAW039) 450 mg once daily orally |
| Placebo | PLACEBO_COMPARATOR | Placebo once daily orally |
| Fevipiprant 450mg | EXPERIMENTAL | 450mg Film Coated Tablet |
| Name | Type | Description |
|---|---|---|
| Fevipiprant 150 mg | DRUG | Fevipiprant (QAW039) 150 mg once daily administered orally as tablet |
| Fevipiprant 450 mg | DRUG | Fevipiprant (QAW039) 450 mg once daily administered orally as tablet |
| Placebo | DRUG | Placebo once daily administered orally as tablet |
| Fevipiprant | DRUG | Single 450mg dose |
Inclusion Criteria: * Patients aged 18 years or more with a diagnosis of nasal polyps with Nasal polyp score \>= 4 with minimum score of 2 in each nostril. * Concomitant diagnosis of asthma for a period of at least 6 months prior to screening. * Patients on stable asthma treatment of at least inhal...
Fevipiprant is an investigational small molecule being studied for nasal polyps and hepatic impairment. It is developed by Novartis AG. The drug is not approved and remains in clinical development.
Fevipiprant is a small molecule, but its specific molecular target has not been disclosed in available information. It is being studied for its effects in conditions like nasal polyps and hepatic impairment.
Fevipiprant is developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker NVS. The drug is currently in clinical trials.
Fevipiprant has completed a Phase 1 trial for hepatic impairment and a Phase 3 trial for nasal polyps. It is not FDA approved and remains investigational.
Fevipiprant has completed two trials: NCT03048448, a Phase 1 pharmacokinetic study in patients with hepatic impairment, and NCT03681093, a Phase 3 efficacy study in patients with nasal polyposis and asthma.
Fevipiprant is also known as QAW039. The Phase 1 trial NCT03048448 refers to Fevipiprant (QAW039) in its title, confirming that QAW039 is an alternative name for the same drug.