Last update 21 Jun 2024
Fevipiprant
Last update 21 Jun 2024
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms Fevipiprant (JAN/USAN/INN), NVP-QAW-039, QAW-039 + [3] |
Target |
Mechanism CRTH2 antagonists(Prostaglandin D2 receptor 2 antagonists), PGD2 receptor antagonists(Prostaglandin D2 receptor antagonists) |
Therapeutic Areas |
Active Indication- |
Inactive Indication |
Originator Organization |
Active Organization- |
Drug Highest PhaseSuspendedPhase 3 |
First Approval Date- |
Regulation- |
Structure
Molecular FormulaC19H17F3N2O4S |
InChIKeyGFPPXZDRVCSVNR-UHFFFAOYSA-N |
CAS Registry872365-14-5 |
Related
31
Clinical Trials associated with FevipiprantA multi-center, proof-of-mechanism study of multiple, oral doses of fevipiprant (QAW039) in COPD patients with eosinophilia
Randomized, Subject and Investigator Blinded, Placebo-controlled Study to Demonstrate the Anti-inflammatory Effect of Fevipiprant (QAW039) in Moderate to Severe Asthma Patients With High Sputum and Blood Eosinophils.
Randomized, subject and investigator blinded, placebo-controlled study to demonstrate the anti-inflammatory effect of fevipiprant (QAW039) in moderate-severe asthma patients with high sputum and blood eosinophils
100 Clinical Results associated with Fevipiprant
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100 Translational Medicine associated with Fevipiprant
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100 Patents (Medical) associated with Fevipiprant
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43
Literatures (Medical) associated with Fevipiprant01 Feb 2023Biotechnology and applied biochemistryQ4 · ENGINEERING & TECHNOLOGY
Pharmacological evaluation of the effects of enzymatically liberated fish oil on eosinophilic inflammation in animal models
Q4 · ENGINEERING & TECHNOLOGY
Article
Author: Framroze, Bomi ; Currie, Crawford ; Bjerknes, Christian ; Singh, Dave ; Hermansen, Erland ; Sharma, Deepali
Abstract:
The inappropriate activation of eosinophils is a well‐recognized driver of various human inflammatory diseases including asthma, chronic rhinitis, and various gastrointestinal diseases, including eosinophilic esophagitis. Steroids, both topical and systemic, remain a cornerstone of treatment and can be highly effective. However, some individuals suffer side effects, unresolved symptoms, or both. OmeGo, an enzymatically liberated fish oil, has demonstrated anti‐inflammatory and antioxidant properties as well the reduction of the activation, migration, and survival of eosinophils. Two animal models of eosinophilic inflammation were used to further assess OmeGo's profile. A house dust mite model of induced asthma showed a significant reduction in eosinophilic lung inflammation compared to the negative control, linoleic acid. The CRTH2 antagonist fevipiprant showed a similar eosinophilic inhibitory profile to OmeGo. In contrast, cod liver oil had no impact on any measure of inflammation. A guinea pig model of mild intraperitoneal eosinophilia showed a significant reduction in eosinophil activity by OmeGo, assessed by chemotaxis and chemokinesis. Apolipoprotein A‐IV, an endogenous human protein with anti‐inflammatory actions, showed a similar but numerically lower effect. OmeGo therefore combines a consistent antieosinophilic action with the known anti‐inflammatory effects of polyunsaturated fatty acids. Proof‐of‐concept studies in asthma are warranted.
04 May 2022Drug development and industrial pharmacy
Commercial scale transfer of a twin-screw melt granulation process for high drug load fevipiprant tablets
Article
Author: Häcker, Hans-Georg ; Rogue, Vincent ; Hirsch, Stefan ; Spickermann, Dirk ; Steib-Lauer, Caroline ; Vicente Martin, Claudia ; Bautista, Manel ; Dhareshwar, Sundeep S. ; Stocker, Stephan
OBJECTIVE:
This work summarizes select methodology of twin-screw melt granulation (TSMG) and process analytical technology that were used in the successful scaling-up and commercial transfer of high drug load (80.5% w/w) immediate release fevipiprant tablets.
SIGNIFICANCE:
The unique and compelling learnings from this industry work are (1) insights into Novartis AG's commercial scale transfer using TSMG and (2) rapid, nondestructive NIR methodology as a PAT tool for RTR testing. No prior literature combines these two aspects at the level of detail we present/disclose.
METHODS:
Scaling up of TSMG was guided by specific energy values obtained for the 27 mm (pilot scale) and 50 mm (commercial scale) twin-screw extruders (TSE). Proven acceptable ranges (PARs) were confirmed by varying the critical process parameters (CPPs) for granulation (screw speed) and tableting (dwell time and crushing strength) at three process levels (upper, target, and lower). An at-line NIR method was developed and validated for real-time release testing (RTRT).
RESULTS:
The combination of CPPs were selected to have the same effect on critical quality attributes (CQAs), that is, lower (-) and upper (+) process level challenged tablet aspect/appearance and dissolution, respectively. TSMG was performed using a 50 mm extruder at constant feed rate. Compression of the six final blends (∼300 kg) showed no impact of varied granulation and compression process conditions on both CQAs. A near-infrared spectroscopy method was validated to determine content uniformity, assay, identity, and to predict CQAs on uncoated tablets in preparation for a real RTRT of future batches.
01 May 2022The Journal of allergy and clinical immunology
Fevipiprant in CRSwNP and comorbid asthma: Wrong target population or wrong PGD2 receptor?
Communications
Author: Cahill, Katherine N
1
News (Medical) associated with Fevipiprant100 Deals associated with Fevipiprant
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D10631 | Fevipiprant | - |
R&D Status
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Nasal Polyps | Phase 3 | US | 26 Mar 2019 | |
| Nasal Polyps | Phase 3 | AR | 26 Mar 2019 | |
| Nasal Polyps | Phase 3 | BE | 26 Mar 2019 | |
| Nasal Polyps | Phase 3 | CA | 26 Mar 2019 | |
| Nasal Polyps | Phase 3 | CZ | 26 Mar 2019 | |
| Nasal Polyps | Phase 3 | DE | 26 Mar 2019 | |
| Nasal Polyps | Phase 3 | IT | 26 Mar 2019 | |
| Nasal Polyps | Phase 3 | NL | 26 Mar 2019 | |
| Nasal Polyps | Phase 3 | PL | 26 Mar 2019 | |
| Severe asthma | Phase 3 | US | 11 Dec 2015 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
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Phase 3 | 877 | (QAW039 150 mg) | glsdyfcmrd(kpfpjfrvqt) = qciyukcuvh zovlrbyvnd (kzwphqmwah, zvdkvfymms - emjfotsurf) View more | - | 03 May 2021 | ||
(QAW039 450 mg) | glsdyfcmrd(kpfpjfrvqt) = opywuxhwzz zovlrbyvnd (kzwphqmwah, qowhgmwlbw - wrcjdpnvzd) View more | ||||||
Phase 3 | 662 | ssvtakiqap(enjvfvdwot) = whsvfcmqzg pekmhfcpak (ynnctgvxba ) | Negative | 25 Apr 2021 | |||
Placebo | ssvtakiqap(enjvfvdwot) = phzmurvwxb pekmhfcpak (ynnctgvxba ) | ||||||
Phase 3 | 604 | (QAW039 150 mg) | fcbgymkdyh(ixgqogngad) = owxgiueefa xqatbffcmu (vpigqcncch, awuvyuzzlz - einuoogmvg) View more | - | 02 Feb 2021 | ||
(QAW039 450 mg) | fcbgymkdyh(ixgqogngad) = jmdauhxtxm xqatbffcmu (vpigqcncch, qgcmkschzb - cioalhuynb) View more | ||||||
Phase 2 | 9 | (QAW039 450 mg) | xcaaffnfcu(nvvbxxsuil) = nnldvhirxq qwtlytwqqd (aeetqbybcz, lykjgkseju - sneuqjtoxr) View more | - | 25 Jan 2021 | ||
Placebo (Placebo) | xcaaffnfcu(nvvbxxsuil) = iatschcvjx qwtlytwqqd (aeetqbybcz, ybzthojpgm - lzgfasxlbt) View more | ||||||
Phase 3 | 98 | (Fevipiprant 150 mg) | xcturmrcdp(vmrgvzunlx) = arksntlpow omdulbqenv (zjjhufcguj, kugtbidzsh - cpkzafyrov) View more | - | 05 Jan 2021 | ||
(Fevipiprant 450 mg) | xcturmrcdp(vmrgvzunlx) = pzbnpwidrf omdulbqenv (zjjhufcguj, vpfdnncsfo - iqmznozpmk) View more | ||||||
Phase 3 | 2,538 | (QAW039 150mg) | jkjeeifvby(crabkkroug) = iyfuqchwfu zekmdogjew (ryorkwrttc, gcgareyoft - nmmynhxtgy) View more | - | 12 Oct 2020 | ||
(QAW039 450 mg) | jkjeeifvby(crabkkroug) = csyygtayvz zekmdogjew (ryorkwrttc, tawrcxfmlh - peyjlmgalr) View more | ||||||
Phase 2 | 11 | (Cohort A Fevipiprant 75 mg) | nwxywrzgfj(juqnfyqcbe) = pnlmrwnubi mprreiogxg (gwyprabovz, fzqgxjxafx - evcbrygwmh) View more | - | 20 Jul 2020 | ||
(Cohort B Feviprant 375 mg) | wdtzlhugmy(kvojqdxtrj) = hepgzhrrbj qwxsoqnipi (jbpxvaelou, nqqsvyeogp - lxulerwutp) View more | ||||||
Phase 3 | 894 | (QAW039 150 mg) | jhidpldpek(izamqkjdqb) = ppxappcgbw vhyktgnafr (nqjtzxyacy, jlooavhuvr - nfgnnnadka) View more | - | 18 May 2020 | ||
(QAW039 450 mg) | jhidpldpek(izamqkjdqb) = fjdovuicbz vhyktgnafr (nqjtzxyacy, qojhrvsnwp - gvzgahuarp) View more | ||||||
Phase 3 | 704 | (QAW039) | hqxnzwkrhy(maymznwjhz) = acahqusnnj pwwsstkuqa (zqzirntpgw, befesqacky - oniiamsdvu) View more | - | 28 Feb 2020 | ||
Placebo (Placebo) | hqxnzwkrhy(maymznwjhz) = apvkupbahz pwwsstkuqa (zqzirntpgw, lukoekbdyq - ecpujuhcdb) View more | ||||||
Phase 3 | 675 | (QAW039) | wzuvmncwfe(gkcoyzclxf) = iysebsbgux gocrhvkbxx (wgfuhhwjrr, wxtegekmpb - aoggipfncc) View more | - | 12 Feb 2020 | ||
Placebo (Placebo) | wzuvmncwfe(gkcoyzclxf) = fbubzjotnk gocrhvkbxx (wgfuhhwjrr, nwflnguubu - kfqufjkenc) View more |
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