Overview
Aceclofenac is an oral non-steroidal anti-inflammatory drug (NSAID) with marked anti-inflammatory and analgesic properties used to treat osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. It is reported to have a higher anti-inflammatory action or at least comparable effects than conventional NSAIDs in double-blind studies . Aceclofenac potently inhibits the cyclo-oxygenase enzyme (COX) that is involved in the synthesis of prostaglandins, which are inflammatory mediators that cause pain, swelling, inflammation, and fever. Aceclofenac belongs to BCS Class II as it possesses poor aqueous solubility . It displays high permeability to penetrate into synovial joints where in patients with osteoarthritis and related conditions, the loss of articular cartilage in the area causes joint pain, tenderness, stiffness, crepitus, and local inflammation . Aceclofenac is also reported to be effective in other painful conditions such as dental and gynaecological conditions . In 1991, aceclofenac was developed as an analog of a commonly prescribed NSAID, Diclofenac, via chemical modification in effort to improve the gastrointestinal tolerability of the drug. It is a more commonly prescribed drug in Europe.
Indication
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Associated Conditions
- Ankylosing Spondylitis (AS)
- Osteoarthritis (OA)
- Rheumatoid Arthritis
Research Report
Aceclofenac (DB06736): A Comprehensive Monograph on its Pharmacology, Clinical Efficacy, and Therapeutic Positioning
1. Introduction and Molecular Profile
Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) belonging to the phenylacetic acid class, developed as a chemical analog of the widely used NSAID, diclofenac.[1] It functions as a potent non-narcotic analgesic and anti-inflammatory agent, primarily indicated for the symptomatic relief of pain and inflammation associated with chronic musculoskeletal disorders.[1] The development of aceclofenac, patented in 1983 and approved for medical use in 1992, represents a strategic effort in rational drug design.[2] By modifying the structure of diclofenac, the goal was to create a therapeutic agent that retained the potent anti-inflammatory efficacy of the parent compound while offering a significantly improved gastrointestinal (GI) tolerability profile, a major limitation of traditional NSAIDs.[1] This monograph provides an exhaustive review of aceclofenac, synthesizing data on its molecular characteristics, complex pharmacology, clinical evidence base, safety profile, and its distinct position within the contemporary therapeutic armamentarium for inflammatory conditions.
1.1. Nomenclature, Classification, and Key Identifiers
Aceclofenac is classified as a small molecule drug that functions as an inhibitor of the enzyme prostaglandin-endoperoxide synthase (EC 1.14.99.1), more commonly known as cyclooxygenase (COX).[1] Its therapeutic classification falls under Anti-Inflammatory Agents, Non-Steroidal.[1] For regulatory and research purposes, it is identified by a comprehensive set of unique codes and numbers across various international databases.
Key identifiers for aceclofenac include:
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/09/28 | Phase 1 | Completed | Il-Yang Pharm. Co., Ltd. | ||
2022/04/21 | Phase 1 | Completed | |||
2022/02/14 | Phase 1 | Completed | Il-Yang Pharm. Co., Ltd. | ||
2020/11/23 | Phase 1 | Completed | |||
2019/10/30 | Phase 4 | Completed | |||
2017/11/07 | Phase 2 | Completed | |||
2017/05/10 | Phase 2 | Completed | |||
2017/04/25 | Phase 1 | UNKNOWN | Dong Wha Pharmaceutical Co. Ltd. | ||
2016/02/15 | Phase 4 | Completed | |||
2008/03/13 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| United Douglas Pharm., Inc. | 65697-450 | ORAL | 200 mg in 1 1 | 10/31/2011 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| AIRTAL FILM COATED TABLETS 100mg | SIN15700P | TABLET, FILM COATED | 100mg | 5/29/2019 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ARACENAC 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Arafarma Group S.A. | 69551 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ACECLOFENACO ARAFARMA GROUP 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Arafarma Group S.A. | 69552 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| ACECLOFENACO ARISTO 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Aristo Pharma Iberia S.L. | 70560 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| ACECLOFENACO VIR 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Industria Quimica Y Farmaceutica Vir S.A. | 74653 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ACECLOFENACO NORMON 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Normon S.A. | 71437 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ACECLOFENACO ALPROFARMA 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Almirall S.L. | 59242 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| ACECLOFENACO AUROVITAS SPAIN 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Aurovitas Spain, S.A.U. | 70982 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| ACECLOFENACO CUVE 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Pharmex Advanced Laboratories S.L. | 68942 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| AIRTAL DIFUCREM 15 mg/g CREMA | 60191 | CREMA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| GERBIN 100 MG COMPRIMIDOS RECUBIERTOS CON PELICULA | Laboratorios Almirall S.L. | 59026 | COMPRIMIDO RECUBIERTO | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.