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Also known as Diclofenac Sodium Topical Gel, 1%
Diclofenac, 1% · 1 trial · 1 indication
Mean change from baseline to week 4 in the Western Ontario McMaster Osteoarthritis (WOMAC) pain score: 5-point Likert scale: none=o, mild=1, moderate=2, severe=3, extreme=4
| Arm | Type | Description |
|---|---|---|
| Diclofenac Sodium Topical Gel, 1% | EXPERIMENTAL | Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks |
| Voltaren Topical Gel, 1% | ACTIVE_COMPARATOR | Voltaren Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks |
| Vehicle Diclofenac Sodium Topical Gel | PLACEBO_COMPARATOR | Vehicle Diclofenac Sodium Topical Gel. 4 gm, 4 times a day for 4 weeks |
| Name | Type | Description |
|---|---|---|
| Diclofenac Sodium Topical Gel, 1% | DRUG | Opaque, white gel |
| Voltaren Topical Gel, 1% | DRUG | Opaque, white gel |
| Vehicle Diclofenac Sodium Topical Gel | DRUG | Opaque, white gel |
Inclusion Criteria: * Healthy, ambulatory male or non-pregnant female subjects aged ≥ 35 years with a clinical diagnosis of OA of the knee. * Had an X-ray of the target knee, taken no more than 1 year before baseline, showing evidence of OA with Kellgren-Lawrence grade 1-3 disease. * After disconti...
Top 5 of 13 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 3 | PHASE3 | Eloralintide and Tirzepatide, Orforglipron, LY3016859, LY3556050, LY3526318 |
| Pacira Biosciences, Inc. | PCRX | 4 | PHASE3 | ZILRETTA, Enekinragene Inzadenovec, FX201 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 1 | PHASE3 | NNC0487-0111 |
| Bioventus, Inc. Class A | BVS | 1 | PHASE2 | PTP-001 |
| Enlivex Ltd. | ENLV | 2 | PHASE1 | Allocetra |
Diclofenac, 1% is a topical gel used to treat osteoarthritis, including osteoarthritis of the knee. It is applied to the skin over the affected joint to deliver the drug locally. Amneal Pharmaceuticals is developing it as a generic version of Voltaren gel for this musculoskeletal condition.
Diclofenac, 1% is a small molecule inhibitor of PTGS2 and PTGS1, the cyclooxygenase enzymes also known as COX-2 and COX-1. By inhibiting these targets, it reduces prostaglandin production, which decreases pain and inflammation in osteoarthritis. The topical formulation delivers the drug through the skin to the joint area.
Diclofenac, 1% is developed by Amneal Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker AMRX. The company is developing this topical gel as a generic alternative to Voltaren gel for osteoarthritis.
Diclofenac, 1% is in Phase 3 development. It is investigational and has not been approved by the FDA. The Phase 3 trial has been completed, and the program is focused on osteoarthritis.
Diclofenac, 1% has been studied in one completed Phase 3 trial, NCT02121002. This randomized, double-blind, placebo-controlled study compared a generic diclofenac sodium topical gel, 1% to Voltaren in 1,176 subjects with osteoarthritis of the knee. The trial was conducted in India.
Yes, Diclofenac, 1% is also known as Diclofenac Sodium Topical Gel, 1%. The two names refer to the same product, a topical gel formulation of diclofenac sodium at 1% strength developed by Amneal Pharmaceuticals for osteoarthritis.