Overview
Diclofenac is a phenylacetic acid derivative and non-steroidal anti-inflammatory drug (NSAID). NSAIDs inhibit cyclooxygenase (COX)-1 and-2 which are the enzyme responsible for producing prostaglandins (PGs). PGs contribute to inflammation and pain signalling. Diclofenac, like other NSAIDs, is often used as first line therapy for acute and chronic pain and inflammation from a variety of causes. Diclofenac was the product of rational drug design based on the structures of phenylbutazone, mefenamic acid, and indomethacin. The addition of two chlorine groups in the ortho position of the phenyl ring locks the ring in maximal torsion which appears to be related to increased potency. It is often used in combination with misoprostol to prevent NSAID-induced gastric ulcers. Diclofenac was first approved by the FDA in July 1988 under the trade name Voltaren, marketed by Novartis (previously Ciba-Geigy).
Background
Diclofenac is a phenylacetic acid derivative and non-steroidal anti-inflammatory drug (NSAID). NSAIDs inhibit cyclooxygenase (COX)-1 and-2 which are the enzyme responsible for producing prostaglandins (PGs). PGs contribute to inflammation and pain signalling. Diclofenac, like other NSAIDs, is often used as first line therapy for acute and chronic pain and inflammation from a variety of causes. Diclofenac was the product of rational drug design based on the structures of phenylbutazone, mefenamic acid, and indomethacin. The addition of two chlorine groups in the ortho position of the phenyl ring locks the ring in maximal torsion which appears to be related to increased potency. It is often used in combination with misoprostol to prevent NSAID-induced gastric ulcers. Diclofenac was first approved by the FDA in July 1988 under the trade name Voltaren, marketed by Novartis (previously Ciba-Geigy).
Indication
Diclofenac is indicated for use in the treatment of pain and inflammation from varying sources including inflammatory conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, as well as injury-related inflammation due to surgery and physical trauma. It is often used in combination with misoprostol as a gastro-protective agent in patients with high risk of developing NSAID-induced ulcers.
Associated Conditions
- Actinic Keratosis (AK)
- Acute Arthritis
- Acute Gouty Arthritis
- Acute Migraine
- Acute Musculoskeletal Pain
- Ankylosing Spondylitis (AS)
- Common Cold
- Fever
- Gout
- Inflammation
- Inflammatory Disease of the Oral Cavity
- Inflammatory Disease of the throat
- Inflammatory Reaction of the Nerve
- Joint Pain
- Juvenile Idiopathic Arthritis (JIA)
- Menstrual Distress (Dysmenorrhea)
- Muscle Inflammation
- Myalgia
- Neuropathic Pain
- Ocular Inflammation
- Osteoarthritis (OA)
- Osteoarthritis of the Knee
- Pain
- Pain caused by Rheumatism
- Pericarditis
- Photophobia
- Postoperative Inflammatory Response
- Postoperative pain
- Primary Dysmenorrhoea
- Radicular Pain
- Rheumatism
- Rheumatoid Arthritis
- Seasonal Allergic Conjunctivitis
- Spinal pain
- Tendon pain
- Vertebral column pain
- Acute Musculoskeletal injury
- Acute, moderate, severe Pain, Inflammatory
- Localized soft tissue rheumatism
- Mild to moderate joint pain
- Mild to moderate pain
- Minor pain
- Perioperative miosis
Research Report
Diclofenac: A Comprehensive Pharmacological and Clinical Review
1. Introduction to Diclofenac
1.1. Overview and Summary
Diclofenac is a well-established phenylacetic acid derivative classified as a non-steroidal anti-inflammatory drug (NSAID).[1] It is primarily utilized for the management of signs and symptoms associated with various arthritic conditions, including osteoarthritis and rheumatoid arthritis.[1] Its therapeutic applications extend to ankylosing spondylitis and a range of other painful states, such as menstrual cramps (primary dysmenorrhea) and acute migraine attacks.[2] The pharmacological profile of diclofenac is characterized by its potent anti-inflammatory, analgesic (pain-relieving), and antipyretic (fever-reducing) activities.[3]
The broad spectrum of indications for diclofenac underscores its efficacy in conditions where prostaglandins play a significant pathogenic role. Prostaglandins are key mediators in inflammation, pain sensitization, and fever development. By inhibiting their synthesis, diclofenac offers relief across a diverse array of clinical scenarios. Its utility in both chronic inflammatory diseases like arthritis and acute painful conditions such as migraines highlights its versatility as a therapeutic agent.[1] This versatility is a direct consequence of its fundamental mechanism of action as an NSAID, which targets the cyclooxygenase (COX) enzymes responsible for prostaglandin production. However, this same mechanism also underpins its potential for adverse effects, particularly concerning the gastrointestinal and cardiovascular systems, which are significant enough to warrant boxed warnings from regulatory authorities like the U.S. Food and Drug Administration (FDA).[3] The widespread and long-standing use of diclofenac implies a considerable clinical impact in pain and inflammation management. Concurrently, this extensive use necessitates a comprehensive understanding and careful consideration of its
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2017/03/27 | Phase 2 | Completed | |||
2017/03/08 | Phase 1 | Completed | |||
2017/03/07 | Phase 1 | Completed | Anne Chang | ||
2017/02/03 | Phase 2 | Completed | Clinical Research Centre, Malaysia | ||
2017/02/01 | Phase 4 | Completed | |||
2017/01/13 | Not Applicable | Terminated | |||
2016/12/07 | Phase 3 | UNKNOWN | Ache Laboratorios Farmaceuticos S.A. | ||
2016/11/02 | Phase 3 | Completed | Balmoral Medical company | ||
2016/09/29 | Phase 4 | UNKNOWN | Bayero University Kano, Nigeria | ||
2016/09/23 | Phase 3 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Proficient Rx LP | 82804-074 | TOPICAL | 20 mg in 1 g | 3/1/2024 | |
| Alembic Pharmaceuticals Inc. | 62332-487 | TOPICAL | 20 mg in 1 g | 1/10/2024 | |
| A-S Medication Solutions | 50090-0542 | ORAL | 50 mg in 1 1 | 7/14/2017 | |
| Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 70934-122 | ORAL | 50 mg in 1 1 | 1/5/2023 | |
| RPK Pharmaceuticals, Inc. | 53002-5360 | ORAL | 75 mg in 1 1 | 7/14/2017 | |
| REMEDYREPACK INC. | 70518-4044 | ORAL | 100 mg in 1 1 | 4/5/2024 | |
| Proficient Rx LP | 71205-995 | ORAL | 50 mg in 1 1 | 7/1/2022 | |
| DIRECTRX | 61919-608 | ORAL | 100 mg in 1 1 | 5/9/2023 | |
| Asclemed USA, Inc. | 76420-332 | TRANSDERMAL | 0.0125 g in 1 g | 6/7/2025 | |
| Alembic Pharmaceuticals Inc. | 62332-581 | TOPICAL | 30 mg in 1 g | 3/1/2023 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Diclofenac Sodium Enteric-coated Tablets | 国药准字H62021184 | 化学药品 | 片剂 | 1/10/2020 | |
| Diclofenac Sodium Enteric-coated Tablets | 国药准字H14020064 | 化学药品 | 片剂 | 4/20/2020 | |
| Diclofenac Sodium Enteric-coated Tablets | 国药准字H22023942 | 化学药品 | 片剂(肠溶) | 7/29/2020 | |
| Diclofenac Sodium Enteric-coated Tablets | 国药准字H65020322 | 化学药品 | 片剂 | 11/5/2020 | |
| Diclofenac Sodium Enteric-coated Tablets | 国药准字H51021629 | 化学药品 | 片剂(肠溶片) | 3/2/2020 | |
| Diclofenac Sodium Enteric-coated Tablets | 国药准字H22021913 | 化学药品 | 片剂(肠溶) | 5/15/2020 | |
| Diclofenac Sodium Enteric-coated Tablets | 国药准字H22020504 | 化学药品 | 片剂 | 4/28/2021 | |
| Diclofenac Sodium Enteric-coated Tablets | 国药准字H22025261 | 化学药品 | 片剂(肠溶) | 4/27/2020 | |
| Diclofenac Sodium Enteric-coated Tablets | 国药准字H64020067 | 化学药品 | 片剂 | 11/14/2019 | |
| Diclofenac Sodium Enteric-coated Tablets | 国药准字H41021932 | 化学药品 | 片剂 | 3/30/2020 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||