Drugs / Piroxicam
Piroxicam
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | FELDENE | — | 1982-04-06 | fda.gov ↗ |
Trials 16
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03612323 | Nov 2018 → May 2019 | pulpitis | Cairo University | Unknown | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT01320709 | Mar 2011 → Mar 2012 | — | Bayer | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04124822 | May 2018 → Jul 2019 | acute apical periodontitis | Dow University of Health Sciences | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07449299 | Mar 2027 → Jun 2031 expected | — | University of Utah | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06727734 | Jan 2025 → Sep 2027 expected | — | The University of Hong Kong | Recruiting | No outcome recorded |
| Phase 3 | NCT03153657 | Dec 2016 → Apr 2017 | dental abscess, dentin sensitivity | Federal University of Sergipe | Completed | No outcome recorded |
| Phase 45 trials · 1 met primary | ||||||
| Phase 4 | NCT07281807 | Jan → Dec 2026 expected | periapical periodontitis | RANA AHMAD | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05488925 | Jun 2021 → Feb 2022 | pulpitis | Farjad Zafar | Completed | Met primary |
| Phase 4 | NCT02253446 | May 2013 → Jul 2014 | primary dysmenorrhea | Pamukkale University | Completed | No outcome recorded |
| Phase 4 | NCT02450487 | Oct 2012 → Oct 2015 | impacted teeth, multiple | University of Sao Paulo | Completed | No outcome recorded |
| Phase 4 | NCT00631514 | Jan 2005 → Sep 2006 | hypertensive disorder | University of Split | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT06943092 | Jan → Jun 2020 | — | Federal Teaching Hospital Abakaliki | Completed | No outcome recorded |
| — | NCT03998826 | Sep 2019 → Sep 2020 | — | Cairo University | Unknown | No outcome recorded |
| — | NCT03745105 | Dec 2018 → Dec 2019 | — | Cairo University | Unknown | No outcome recorded |
| — | NCT02382653 | Dec 2014 → Apr 2015 | metastatic neoplasm | Tanta University | Completed | No outcome recorded |
| — | NCT00530387 | Jul 2008 → Jul 2011 | photoallergic dermatitis | NHS Tayside | Completed | No outcome recorded |
| Comparator or background therapy14 trials | ||||||
| Phase 0 | NCT04062591 Comparator | Aug 2019 → Apr 2022 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 1 | NCT05104931 Comparator | Dec 2020 → Feb 2021 | — | Nanoform Finland Plc | Completed | No outcome recorded |
| Phase 2 | NCT05722782 Comparator | Jul 2023 → Jun 2027 expected | urinary tract obstruction | University of Monastir | Recruiting | No outcome recorded |
| Phase 2 | NCT00670475 Comparator | Apr 2008 → May 2009 | osteoarthritis, knee | Ardabil University of Medical Sciences | Completed | No outcome recorded |
| Phase 2/3 | NCT04201249 Comparator | Dec 2019 → Dec 2021 | epicondylitis | Hospital de Santa Maria, Portugal | Unknown | No outcome recorded |
| Phase 2/3 | NCT03614494 Comparator | Aug 2018 → Oct 2022 | — | Dr. Hang Wun Raymond Li | Completed | No outcome recorded |
| Phase 2/3 | NCT03626753 Comparator | Jan → Jun 2015 | puerperal infection | Centre de Maternité de Monastir | Completed | No outcome recorded |
| Phase 3 | NCT07475663 Comparator | Nov 2025 → Feb 2026 | epicondylitis, osteoarthritis, knee, patellofemoral pain syndrome, tenosynovitis of foot and ankle | Taisho Pharmaceutical Indonesia | Completed | No outcome recorded |
| Phase 3 | NCT06404177 Comparator | Jul 2023 → Aug 2024 | — | Riadh Boukef | Unknown | No outcome recorded |
| Phase 3 | NCT03222518 Comparator | Mar 2017 → Nov 2018 | — | University of Monastir | Completed | No outcome recorded |
| Phase 3 | NCT02304783 Comparator | Jan 2014 → Jun 2021 | — | University of Monastir | Completed | No outcome recorded |
| Phase 4 | NCT00649415 Comparator | Jan → Jul 2003 | primary dysmenorrhea | Pfizer | Completed | No outcome recorded |
| — | NCT04296422 Comparator | Jan 2019 → Sep 2020 | premenstrual tension | Taipei City Hospital | Unknown | No outcome recorded |
| — | NCT03881319 Comparator | Jun 2018 → Dec 2019 | dysmenorrhea, premenstrual tension | Taipei City Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2018-07-19 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Piroxicam Capsules USP zyduslife.com ↗ |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2018-07-19 | Zydus Lifesciences Limited | Zydus receives final approval from the USFDA for Piroxicam Capsules USP zyduslife.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 31 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Piroxicam | “During this 3-month study, two antihypertensives, lisinopril/hydrochlorothiazide and amlodipine, were compared with three NSAIDs: ibuprofen, acetaminophen, and piroxicam.” PMID 18953082 ↗ Oct 200828“14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period” NCT03222518 ↗ “NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin.” NCT03881319 ↗ “NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam.” NCT04296422 ↗ “Oral Piroxicam Versus Buccal Fentanyl in Breakthrough Pain” NCT02382653 ↗ “Piroxicam 1%” NCT00530387 ↗ |
| Known as | BAYl1902 | “Piroxicam ( BAYl1902)” NCT01320709 ↗ |
| Known as | Brexidol (piroxicam) Tablets | “Drug: Brexidol (piroxicam) Tablets” NCT05104931 ↗ |
| Known as | Felden (piroxicam) Tablets | “Drug: Felden (piroxicam) Tablets” NCT05104931 ↗ |
| Known as | Feldene | “Pretreatment intraligamentary injection of 0.4 mL of 20 mg mL-1 piroxicam (Feldene, Pfizer, Egypt)” NCT03745105 ↗ |
| Known as | Nanoformed Piroxicam IR Tablet | “Drug: Nanoformed Piroxicam IR Tablet” NCT05104931 ↗ |
| Known as | Pirofel gel | “Piroxicam 0.5% (Brand name Pirofel® gel)” NCT07475663 ↗ |
| Known as | piroxan | “2 tablets of "piroxicam (piroxan)" administrated orally once per 24 hours.” NCT03626753 ↗ |
| Known as | Piroxicam-Beta-Cyclodextrin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03153657 ↗ |
| Action | Inhibit | “Piroxicam, a non-selective COX inhibitor drug” NCT02304783 ↗ |
| Route | Oral | “piroxicam (10-20 mg o.d. per os)” NCT00631514 ↗ |