Drugs / rofecoxib
rofecoxib
also known as
MK0966 · Vioxx · M01AH02 · MK-966 · NSC-720256 · NSC-758705 · TRM-201 · Vioxx (Registered Trademark)
Small molecule targets PTGS2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | VIOXX | — | 2002-04-11 – 2004-08-19 | fda.gov ↗ |
| Approved | US (FDA) | VIOXX | — | 1999-05-20 | fda.gov ↗ |
Trials 26
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT00038389 | Oct 2001 → Oct 2004 | brain neoplasm, glioma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT00050362 | Dec 2002 → Oct 2004 | — | National Institute of Dental and Craniofacial Research (NIDCR) | Completed | No outcome recorded |
| Phase 2 | NCT00026819 | Nov 2001 → Nov 2003 | — | National Institute of Dental and Craniofacial Research (NIDCR) | Completed | No outcome recorded |
| Phase 2/32 trials · 2 missed | ||||||
| Phase 2/3 | NCT00385606 | Jan 2003 → Dec 2005 | non-small cell lung carcinoma | National Cancer Institute, Naples | Completed | Missed primary |
| Phase 2/3 | NCT00004845 | ? → Dec 2001 | Alzheimer disease | National Institute on Aging (NIA) | Completed | Missed primary |
| Phase 315 trials | ||||||
| Phase 3 | NCT04684511 | Jun 2021 → Sep 2022 | hemophilic arthropathy | Tremeau Pharmceuticals, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00165048 | Oct 2004 → ? | gastric cancer | Chinese University of Hong Kong | Unknown | No outcome recorded |
| Phase 3 | NCT00164892 | Oct 2004 → ? | gastric cancer | Chinese University of Hong Kong | Unknown | No outcome recorded |
| Phase 3 | NCT00092378 | Sep → Dec 2003 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00092352 | Apr → Dec 2003 | osteoarthritis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00092365 | Apr → Nov 2003 | osteoarthritis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00140933 | Apr 2003 → ? | — | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 3 | NCT00060476 | Jan 2003 → Dec 2004 | prostate cancer | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00092339 | Aug → Sep 2002 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00092326 | Jun → Sep 2002 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00092313 | Jun → Sep 2002 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00092300 | May → Sep 2002 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00390260 | Feb 2002 → Feb 2003 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00031863 | Feb 2001 → Sep 2007 | colorectal cancer | Cancer Research Campaign Clinical Trials Centre | Completed | No outcome recorded |
| Phase 3 | NCT00282386 | Dec 1999 → Sep 2004 | colorectal adenoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT00140920 | May → Sep 2004 | — | Merck Sharp & Dohme LLC | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00157872 | Jan → Jul 2004 | rheumatoid arthritis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 4 | NCT00140894 | Aug 2002 → Oct 2004 | classic or attenuated familial adenomatous polyposis | Merck Sharp & Dohme LLC | Terminated | No outcome recorded |
| Phase 4 | NCT00261586 | ? → Mar 2004 | — | Johnson & Johnson Consumer and Personal Products Worldwide | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT00263094 | Sep → Nov 2004 | headache disorder | Sheba Medical Center | Completed | No outcome recorded |
| — | NCT01762891 | Mar 2003 → Jul 2006 | antiphospholipid syndrome | Hospital Universitario Pedro Ernesto | Completed | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| Phase 2/3 | NCT00844727 Comparator | Sep 2003 → Apr 2004 | polyposis | Oslo University Hospital | Terminated | No outcome recorded |
| Phase 3 | NCT00637949 Comparator | Dec 2000 → Mar 2001 | osteoarthritis | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT00568295 Comparator | Oct 1999 → Oct 2000 | osteoarthritis, knee | Johnson & Johnson Consumer and Personal Products Worldwide | Completed | No outcome recorded |
| Phase 4 | NCT00657449 Comparator | Jun 2003 → Oct 2004 | — | Pfizer | Terminated | No outcome recorded |
| Phase 4 | NCT00637988 Comparator | Apr 2002 → Jun 2003 | Barrett esophagus | AstraZeneca | Completed | No outcome recorded |
Press releases naming this drug 7 releases
| Date | Issuer | Release |
|---|---|---|
| 2016-01-15 | Merck Sharp & Dohme LLC | Merck Resolves Previously Disclosed Securities Class Action Lawsuit Related to Vioxx merck.com ↗ |
| 2012-11-01 | Merck Sharp & Dohme LLC | Merck Resolves Previously Disclosed Missouri Consumer Class Action Lawsuit Related to Vioxx merck.com ↗ |
| 2012-02-10 | Merck Sharp & Dohme LLC | Kentucky Court Of Appeals Reverses Certification of a Class of Plaintiffs Seeking Reimbursement for Vioxx® Costs merck.com ↗ |
| 2012-01-19 | Merck Sharp & Dohme LLC | Merck Resolves Vioxx® Litigation in Canada merck.com ↗ |
| 2011-11-22 | Merck Sharp & Dohme LLC | Merck Resolves Previously Disclosed Seven-Year Investigation Led by U.S. Attorney’s Office for the District of Massachusetts Related to Vioxx® merck.com ↗ |
| 2011-10-12 | Merck Sharp & Dohme LLC | Full Federal Court Rules in MSD Australia’s Favour in Vioxx® Case merck.com ↗ |
| 2011-08-26 | Merck Sharp & Dohme LLC | Texas Supreme Court Finds for Merck in VIOXX® Case merck.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 33 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Rofecoxib | “Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Rofecoxib 50 mg and Hydrocodone 7.5 mg With Acetaminophen 750 mg in Patients With Postoperative Arthroscopic Pain” NCT00390260 ↗ |
| Known as | M01AH02 | ChEMBL registry synonym — accepted as the source's own label CHEMBL122 ↗ |
| Known as | MK-966 | ChEMBL registry synonym — accepted as the source's own label CHEMBL122 ↗ |
| Known as | MK0966 | “MK0966; rofecoxib / Duration of Treatment: 24 weeks” NCT00140894 ↗10“MK0966, rofecoxib” NCT00092339 ↗ “MK0966, rofecoxib” NCT00092378 ↗ “MK0966, rofecoxib” NCT00092326 ↗ “MK0966; rofecoxib” NCT00157872 ↗ “MK0966, rofecoxib” NCT00092365 ↗ “MK0966, rofecoxib” NCT00092352 ↗ “MK0966; rofecoxib” NCT00140920 ↗ “MK0966, rofecoxib” NCT00092300 ↗ “MK0966; rofecoxib” NCT00140933 ↗ “MK0966, rofecoxib” NCT00092313 ↗ |
| Known as | NSC-720256 | ChEMBL registry synonym — accepted as the source's own label CHEMBL122 ↗ |
| Known as | NSC-758705 | ChEMBL registry synonym — accepted as the source's own label CHEMBL122 ↗ |
| Known as | TRM-201 | “TRM-201 (Rofecoxib)” NCT04684511 ↗ |
| Known as | Vioxx | “Oral Vioxx (Rofecoxib)” NCT00164892 ↗ |
| Known as | Vioxx (Registered Trademark) | “potent selective COX-2 inhibitor, rofecoxib (Vioxx® (Registered Trademark)), given prior to and following third molar extractions to reduce postoperative pain” NCT00026819 ↗ |
| Action | Inhibit | “selective cyclooxygenase (COX) -2 inhibitor (rofecoxib)” PMID 12783912 ↗ Jun 20031“Cyclooxygenase-2 inhibitor” CHEMBL122 ↗ |
| Modality | Small molecule | — CHEMBL122 ↗ |
| Route | Oral | “Rofecoxib 50 mg will be administered PO 90 minutes before surgery” NCT00026819 ↗ |
| Target | PTGS2 | “Cyclooxygenase-2 inhibitor” CHEMBL122 ↗ |