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Drug

Piroxicam

Approved medicine
ClassCyclooxygenase inhibitorResearchOngoing clinical research

Also known as Feldene, Pyroxycam, 4-Hydroxy-2-methyl-N-(2-pyridyl)-2H-1,2-benzothiazin-3-caboxyamid-1,1-dioxid, Piroxicamum.

RxNorm8356ChEMBLCHEMBL527ATCM01AC01ATCM02AA07ATCS01BC06UNII13T4O6VMAM
3
Active clinical trials
2
Protein targets
18
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: PIROXICAM (ANDA206152)

Regulatory2026-07-31FDA

Label change: PIROXICAM (ANDA206136)

Regulatory2026-06-25FDA

Label change: PIROXICAM (ANDA210347)

Regulatory2026-06-25FDA

Levonorgestrel-piroxicam Combination Versus Ulipristal Acetate for Emergency Contraception: a Randomised Double-blind Controlled Trial

Clinical trial2026-05-14Results expected Q3 2027 · ClinicalTrials.gov

Comparison of the Pain Levels of Single-Dose Premedication With Piroxicam and Prednisolone on Post-Endodontic Pain in Single-Visit Root Canal Treatment of Premolars

Clinical trial2025-12-15Results expected Q4 2026 · ClinicalTrials.gov

Dexketoprofen ® IV Versus Piroxicam® IM in Emergency Pain Management

Clinical trial2024-08-01Primary completion · ClinicalTrials.gov

Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception: Randomised Controlled Trial

Clinical trial2024-05-06Results posted · ClinicalTrials.gov

The Investigation of the Efficacity and Safety of Oral Non Steroidal Anti Inflammatory (NSAI) Drugs Such as Piroxicam as a Second Line Treatment of Patients Consulting the Emergency Department for Renal Colics

Clinical trial2023-11-14Results expected Q2 2027 · ClinicalTrials.gov

Label change: PIROXICAM (ANDA206136)

Regulatory2023-02-21FDA

Label change: PIROXICAM (ANDA206136)

Regulatory2023-02-21FDA

Label change: PIROXICAM (ANDA206152)

Regulatory2023-02-03FDA

Label change: PIROXICAM (ANDA206152)

Regulatory2023-02-03FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Piroxicam
Aliases & brands
FeldenePyroxycam4-Hydroxy-2-methyl-N-(2-pyridyl)-2H-1,2-benzothiazin-3-caboxyamid-1,1-dioxidPiroxicamum
RxNorm CUI
8356
ChEMBL ID
CHEMBL527
ATC codes
M01AC01M02AA07S01BC06
UNII
13T4O6VMAM
Primary mechanism
Cyclooxygenase inhibitor
Regulatory jurisdictions
mhrafda

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Prostaglandin G/H synthase 2
PTGS2 · P35354
INHIBITORCyclooxygenase inhibitor
Prostaglandin G/H synthase 1
PTGS1 · P23219
INHIBITORCyclooxygenase inhibitor

Regulatory timeline

18 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2017-06-20
Latest approval
2018-07-23
Authorities
FDA · MHRA
Total events
18
fdaU.S. Food and Drug Administration· 17 events
2026-07-31Label change
Label change: PIROXICAM (ANDA206152)
Evidence ↗
2026-06-25Label change
Label change: PIROXICAM (ANDA206136)
Evidence ↗
2026-06-25Label change
Label change: PIROXICAM (ANDA210347)
Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Piroxicam: new restrictions, including specialist initiation
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

17 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
17
registered trials across all phases
LATEST COMPLETION 2022
3
Active studies
3
Recruiting
13
Late-stage (III+)
12
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 17
Early Phase 11Phase 23Phase 2 / 32Phase 33Phase 46Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Comparison of the Pain Levels of Single-Dose Premedication With Piroxicam and Prednisolone on Post-Endodontic Pain in Single-Visit Root Canal Treatment of Premolars

Not yet recruitingPH IVRANA AHMADn=602027

Comparison of Preoperative Analgesics on the Efficacy of Inferior Alveolar Nerve Block on Patients With Symptomatic Irreversible Pulpitis: a Double Blinded, Randomized Controlled Trial.

CompletedPH IVFarjad Zafarn=1202022

Influence of Genotype of Cytochrome P450 (CYP2C9) on Clinical Efficacy and Pharmacokinetics of Piroxicam After Lower Third Molar Surgery

CompletedPH IVUniversity of Sao Paulon=1052015

A Comparison of Analgesic İmpacts of Piroxicam and Diclofenac Sodium in the Treatment of Primary Dysmenorrhea:A Double-Blind, Randomized Trial

CompletedPH IVPamukkale Universityn=4002014

Relevance of the Interaction Between Antihypertensive and Antirheumatic Drugs in a Family Practice

CompletedPH IVUniversity of Splitn=882006

Recent completions

Trials that read out recently, adding to the completed evidence base.

Efficacy of Piroxicam as a Perioperative Analgesic for Patients Undergoing Fixation of Maxillofacial Fractures

CompletedPH IAin Shams Universityn=722022

Piroxicam and Levonorgestrel Co-treatment for Emergency Contraception: Randomised Controlled Trial

CompletedPH II/IIIDr. Hang Wun Raymond Lin=8602022

Comparison of Preoperative Analgesics on the Efficacy of Inferior Alveolar Nerve Block on Patients With Symptomatic Irreversible Pulpitis: a Double Blinded, Randomized Controlled Trial.

CompletedPH IVFarjad Zafarn=1202022

The Investigation of the Efficacity and Safety of Oral Non Steroidal Anti Inflammatory (NSAI) Drugs Such as Piroxicam as a Second Line Treatment of Patients Consulting the Emergency Departement for Renal Colics.

CompletedPH IIIKey trialUniversity of Monastirn=1,4002021

Efficacy of Piroxicam Versus Diclofenac as Components of Multimodal Analgesic for Post Caesarean Section Analgesia.

CompletedN/AFederal Teaching Hospital Abakalikin=1082020

Effectiveness of Single Dose Pre Medication of Piroxicam and Prednisolone on Post Endodontic Pain After a One Visit Root Canal Treatment. Randomized Trial .

CompletedPH II/IIIDow University of Health Sciencesn=602019
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.