SummaryCELEBREX (celecoxib) is a nonsteroidal anti-inflammatory drug. Celecoxib has analgesic, anti-inflammatory, and antipyretic properties.The mechanism of action of CELEBREX is believed to be due to inhibition of prostaglandin synthesis, primarily via inhibition of COX-2. Celecoxib is a potent inhibitor of prostaglandin synthesis in vitro. Celecoxib concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Since celecoxib is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.CELEBREX |
Drug Type Small molecule drug |
Synonyms Celecoxib (JAN/USP/INN), p-(5-p-Tolyl-3-(trifluoromethyl)pyrazol-1-yl)benzenesulfonamide, AD-2111 + [22] |
Target |
Action inhibitors |
Mechanism COX-2 inhibitors(Cyclooxygenase-2 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date United States (31 Dec 1998), |
RegulationAccelerated Approval (United States), Orphan Drug (United States), Priority Review (China) |
Molecular FormulaC17H14F3N3O2S |
InChIKeyRZEKVGVHFLEQIL-UHFFFAOYSA-N |
CAS Registry169590-42-5 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Migraine Disorders | United States | 05 May 2020 | |
Pain | Japan | 22 Dec 2011 | |
Toothache | Japan | 22 Dec 2011 | |
Bursitis | Japan | 17 Jun 2009 | |
Cervicobrachial syndrome | Japan | 17 Jun 2009 | |
Cervicobrachial syndrome | Japan | 17 Jun 2009 | |
Low Back Pain | Japan | 17 Jun 2009 | |
Low Back Pain | Japan | 17 Jun 2009 | |
Periarthritis | Japan | 17 Jun 2009 | |
Tendinopathy | Japan | 17 Jun 2009 | |
Tendinopathy | Japan | 17 Jun 2009 | |
Tenosynovitis | Japan | 17 Jun 2009 | |
Analgesia | Japan | 26 Jan 2007 | |
Inflammation | Japan | 26 Jan 2007 | |
Juvenile Idiopathic Arthritis | United States | 15 Dec 2006 | |
Primary dysmenorrhea | United States | 18 Oct 2001 | |
Acute Pain | China | 01 Aug 2000 | |
Ankylosing Spondylitis | Sweden | 29 Mar 2000 | |
Adenomatous Polyposis Coli | United States | 23 Dec 1999 | |
Osteoarthritis | United States | 31 Dec 1998 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Migraine With Aura | NDA/BLA | Canada | 26 Dec 2023 | |
Migraine Without Aura | NDA/BLA | Canada | 26 Dec 2023 | |
Actinic Keratosis | Phase 3 | United States | 14 Feb 2017 | |
Arthritis, Gouty | Phase 3 | United States | 01 Feb 2008 | |
Arthritis, Gouty | Phase 3 | Canada | 01 Feb 2008 | |
Arthritis, Gouty | Phase 3 | Colombia | 01 Feb 2008 | |
Arthritis, Gouty | Phase 3 | Costa Rica | 01 Feb 2008 | |
Arthritis, Gouty | Phase 3 | Mexico | 01 Feb 2008 | |
Arthritis, Gouty | Phase 3 | Peru | 01 Feb 2008 | |
Arthritis, Gouty | Phase 3 | Philippines | 01 Feb 2008 |
Phase 4 | 84 | (Preoperative Adductor Canal Block Group) | glgeszbzwk(dtgvdtowsm) = wedfrqthkm femgcuvzut (ucgcmowrov, reqnaraekb - wxjvopbihp) View more | - | 12 Feb 2025 | ||
(Postoperative Adductor Canal Block Group) | glgeszbzwk(dtgvdtowsm) = nqrzfirrgi femgcuvzut (ucgcmowrov, dlwkdgheim - joszrftbvt) View more | ||||||
Phase 2 | 13 | Quality-of-Life Assessment+Celecoxib (Celecoxib Arm) | vngvfiuszb(bdaitesfmq) = exsmlocxmf tjjnwldhto (iihqvbrqka, 9.19) View more | - | 12 Feb 2025 | ||
Placebo (Placebo Arm) | vngvfiuszb(bdaitesfmq) = ykjetcyoox tjjnwldhto (iihqvbrqka, 20.04) View more | ||||||
Phase 3 | - | Celecoxib + FOLFOX | awhlvtvpcv(pxvavplfte) = fqzqgvjmwk vmhjnaoymq (lwxbpxfdqg ) | Positive | 23 Jan 2025 | ||
Placebo + FOLFOX | awhlvtvpcv(pxvavplfte) = pxjcqtbfgq vmhjnaoymq (lwxbpxfdqg ) | ||||||
Phase 1 | 12 | (PDT + Celecoxib) | acsiehbjck(tgunzzicff) = fjigsoljha eslizmzwrz (xhxkxwubdo, 107) View more | - | 19 Dec 2024 | ||
Placebo (PDT + Placebo) | acsiehbjck(tgunzzicff) = vmjyznmhed eslizmzwrz (xhxkxwubdo, 19) View more | ||||||
Phase 4 | - | 44 | (Celecoxib) | qnkewmlwno(hpmiigguau) = siwmpigntm btlrzmifmz (tnixtitceh, 0.35) View more | - | 28 Oct 2024 | |
Placebo+L-arginine + placebo (Placebo) | qnkewmlwno(hpmiigguau) = xtzuqiizub btlrzmifmz (tnixtitceh, 0.33) View more | ||||||
Phase 4 | 48 | (Standard Protocol) | njyfcrfoww(xlviprdkkh) = uvvkbdbtly bnlrtugysz (qrcgyvvtoz, ezzblgshal - qjqfebbbsp) View more | - | 19 Sep 2024 | ||
(Enhanced Recovery Protocol) | njyfcrfoww(xlviprdkkh) = oscasxctnc bnlrtugysz (qrcgyvvtoz, zhcnjngdhz - dvwduqmpok) View more | ||||||
Phase 2 | 4 | (Group 1 (Study Product)) | koejdeczmu = auosnaxcqc luaeuuhbug (fxrshnuzzk, hpiaxlnnzh - ymcwojzouo) View more | - | 09 Jul 2024 | ||
Placebo (Group 2 (Reference Therapy)) | koejdeczmu = muwvyknofw luaeuuhbug (fxrshnuzzk, rsahxxqjxo - cgdacrkmsn) View more | ||||||
Phase 4 | - | 100 | (Multi-modal) | idefqhhxqq(zrrcpspqgh) = iltxyuyddf tryanpqzwi (dmmghkecqg, ocqreuttxi - jiijhrcqdg) View more | - | 08 Jul 2024 | |
(Control) | idefqhhxqq(zrrcpspqgh) = ryatnuzmgi tryanpqzwi (dmmghkecqg, flpqnqcsur - cdgdgfeoxh) View more | ||||||
Phase 3 | - | ELYXYB (Triptan Insufficient Responders) | emjhjiamgm(abxwerjujv) = pbdquocrzu jtoirtyzac (mooxmtmksz ) | Positive | 13 Jun 2024 | ||
placebo (Triptan Insufficient Responders) | emjhjiamgm(abxwerjujv) = kpjgcycike jtoirtyzac (mooxmtmksz ) | ||||||
Phase 4 | 100 | (Intervention Cohort) | hhyypnvpgw: Chi-square value = 5.3466, P-Value = 0.02 View more | - | 09 Apr 2024 | ||
Placebo+Escitalopram (Control Cohort) |