Active Ingredient History
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) of the phenylacetic acid class with anti-inflammatory, analgesic, and antipyretic properties. Contrary to the action of many traditional NSAIDs, diclofenac inhibits cyclooxygenase (COX)-2 enzyme with greater potency than it does COX-1. In addition diclofenac can inhibit the thromboxane-prostanoid receptor, affect arachidonic acid release and uptake, inhibit lipoxygenase enzymes, and activate the nitric oxide-cGMP antinociceptive pathway. Other novel mechanisms of action may include the inhibition of substrate P, inhibition of peroxisome proliferator activated receptor gamma (PPARgamma), blockage of acid-sensing ion channels, alteration of interleukin-6 production, and inhibition of N-methyl-D-aspartate (NMDA) receptor hyperalgesia. Similar to other NSAIDs, diclofenac is associated with serious dose-dependent gastrointestinal, cardiovascular, and renal adverse effects. Since its introduction in 1973, a number of different diclofenac-containing drug products have been developed with the goal of improving efficacy, tolerability, and patient convenience. Delayed- and extended-release forms of diclofenac sodium were initially developed with the goal of improving the safety profile of diclofenac and providing convenient, once-daily dosing for the treatment of patients with chronic pain. New drug products consisting of diclofenac potassium salt were associated with faster absorption and rapid onset of pain relief. These include diclofenac potassium immediate-release tablets, diclofenac potassium liquid-filled soft gel capsules, and diclofenac potassium powder for oral solution. The advent of topical formulations of diclofenac enabled local treatment of pain and inflammation while minimizing systemic absorption of diclofenac. SoluMatrix diclofenac, consisting of submicron particles of diclofenac free acid and a proprietary combination of excipients, was developed to provide analgesic efficacy at reduced doses associated with lower systemic absorption. The drug's likely impact on the Asian vulture population was widely reported. The dramatic mortality was attributed largely to renal failure caused by exposure to diclofenac in livestock carcasses on which the birds fed. Although not the most endearing species, vultures are important environmental scavengers and, since veterinary use of diclofenac was stopped in the region in 2006, the decline in vulture numbers has slowed. NCATS
Drug Pricing (per unit)
Note: This drug pricing data is preliminary, incomplete, and may contain errors.
Combination drugs
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
| Organization | Org Type | FDA approvals | Clinical Trials involvement | Org ID | Force Sort |
|---|
Achilles Tendon (Phase 4)
Acute Pain (Phase 3)
Aging (Phase 1)
Analgesia (Phase 2/Phase 3)
Analgesics (Phase 1/Phase 2)
Analgesics, Opioid (Phase 4)
Anemia (Phase 3)
Anesthesia (Phase 4)
Anesthesia, Local (Phase 2/Phase 3)
Ankle Injuries (Phase 4)
Antipyretics (Phase 1/Phase 2)
Arthralgia (Phase 2)
Arthritis (Phase 3)
Arthroplasty (Phase 3)
Athletic Injuries (Phase 4)
Axial Spondyloarthritis (Phase 4)
Back Pain (Phase 4)
Biological Availability (Early Phase 1)
Bleeding Time (Phase 3)
Blood Loss, Surgical (Phase 3)
Brain Injuries, Traumatic (Phase 4)
Breast (Phase 2/Phase 3)
Breast Neoplasms (Phase 1)
Buprenorphine (Phase 2/Phase 3)
Candidiasis, Vulvovaginal (Phase 2/Phase 3)
Carcinoma, Basal Cell (Phase 2)
Carpal Tunnel Syndrome (Phase 1)
Cataract (Phase 4)
Cesarean Section (Phase 4)
Chest Pain (Phase 4)
Chronic Pain (Phase 3)
Chronic Periodontitis (Phase 1/Phase 2)
Colic (Phase 3)
Common Bile Duct Diseases (Phase 2/Phase 3)
COVID-19 (Phase 1)
Depression (Phase 1/Phase 2)
De Quervain Disease (Phase 2/Phase 3)
Dermatology (Phase 4)
Diabetes Mellitus (Phase 2)
Dietary Supplements (Phase 2)
Drugs, Generic (Phase 1)
Dysmenorrhea (Phase 4)
Elbow (Phase 2/Phase 3)
Empyema, Pleural (Phase 4)
Endoscopy (Phase 2/Phase 3)
Facial Pain (Phase 4)
Family Planning Services (Phase 4)
Fever (Phase 4)
Fissure in Ano (Phase 4)
General Surgery (Phase 4)
Glaucoma (Phase 4)
Gout (Phase 2)
Graves Disease (Phase 4)
Hallux Valgus (Phase 4)
Headache (Phase 4)
Healthy Volunteers (Phase 4)
Hematuria (Phase 4)
Hemorrhoids (Phase 4)
Hepatic Insufficiency (Phase 1)
Hip Fractures (Phase 4)
Hyperacusis (Phase 3)
Hyperemia (Phase 4)
Hypertrophy, Left Ventricular (Phase 1)
Hysteroscopy (Phase 3)
Infertility (Phase 3)
Infertility, Female (Phase 4)
Inflammation (Phase 3)
Intraocular Pressure (Phase 4)
Keratosis, Actinic (Phase 4)
Kidney Diseases (Phase 4)
Kidney Failure, Chronic (Phase 2)
Knee Injuries (Phase 3)
Leg Injuries (Phase 4)
Ligaments (Phase 4)
Limb Deformities, Congenital (Phase 4)
Low Back Pain (Phase 4)
Lower Urinary Tract Symptoms (Phase 4)
Lung Diseases (Phase 4)
Lung Neoplasms (Phase 4)
Macular Edema (Phase 4)
Mandibular Diseases (Phase 4)
Mastodynia (Phase 2/Phase 3)
Melanoma (Phase 2)
Migraine Disorders (Phase 4)
Multiple Sclerosis (Phase 4)
Musculoskeletal Diseases (Phase 4)
Musculoskeletal Pain (Phase 1)
Myalgia (Phase 3)
Myopia (Phase 3)
Neck Pain (Phase 4)
Neoplasms (Phase 2)
Neurofibroma (Phase 2)
Neurofibromatosis 1 (Phase 2)
Obstetrics (Phase 2)
Onychomycosis (Phase 2)
Osteoarthritis, Hip (Phase 4)
Osteoarthritis, Knee (Phase 4)
Otitis Externa (Phase 2)
Pain ()
Pain Management (Phase 4)
Pain, Postoperative (Phase 4)
Pain, Procedural (Phase 3)
Pancreatic Neoplasms (Phase 2)
Pancreatitis (Phase 4)
Paresthesia (Phase 4)
Pericardial Effusion (Phase 4)
Perineum (Phase 2)
Pharmacokinetics (Phase 1)
Pharyngitis (Phase 4)
Photophobia (Phase 3)
Photosensitivity Disorders (Phase 4)
Pleural Effusion (Phase 4)
Pleural Neoplasms (Phase 4)
Pneumothorax (Phase 4)
Poisoning (Phase 2)
Post-Dural Puncture Headache (Phase 4)
Postoperative Complications (Phase 4)
Prostatic Neoplasms (Phase 2)
Pulmonary Embolism (Phase 2/Phase 3)
Pulpitis (Phase 4)
Quality of Life (Phase 4)
Radiculopathy (Phase 3)
Rectal Fistula (Phase 4)
Renal Colic (Phase 4)
Renal Insufficiency, Chronic (Phase 1)
Respiratory Aspiration (Phase 4)
Respiratory Insufficiency (Early Phase 1)
Respiratory Tract Infections (Phase 4)
Rotator Cuff Injuries (Phase 2/Phase 3)
Seizures (Phase 4)
Shoulder Injuries (Phase 2/Phase 3)
Soft Tissue Injuries (Phase 3)
Spondylitis, Ankylosing (Phase 4)
Sprains and Strains (Phase 4)
Stomach Ulcer (Phase 3)
Subarachnoid Hemorrhage (Phase 4)
Sunburn (Phase 3)
Temporomandibular Joint Disorders (Phase 4)
Tendon Injuries (Phase 2/Phase 3)
Therapeutic Equivalency (Early Phase 1)
Thrombophlebitis (Phase 4)
Tooth Abnormalities (Phase 4)
Traumatology (Phase 3)
Urinary Bladder Neoplasms (Phase 4)
Urinary Calculi (Phase 4)
Urinary Tract Infections (Phase 4)
Uveitis (Phase 1)
| Trial | Phase | Start Date | Organizations | Indications |
|---|
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