REGRANEX (becaplermin) Gel

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved December 1997

Specific Treatments:

diabetic foot ulcers

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General Information

REGRANEX (becaplermin) Gel .01% has been approved for the treatment of diabetic foot ulcers that extend into the subcutaneous tissue or beyond, and have an adequate blood supply. This new topical gel, which contains genetically engineered platelet-derived growth factor, is the first prescription biologic that actively stimulates the body to grow new tissue to heal these wounds.

Clinical Results

Clinical trials demonstrated that a once daily topical application of REGRANEX Gel plus good ulcer care healed more diabetic ulcers than placebo gel plus good ulcer care.

Side Effects

REGRANEX Gel was well tolerated in all clinical trials. Incidence of adverse events was similar in patients treated with REGRANEX, placebo gel, or good ulcer care alone.

Mechanism of Action

The active ingredient in REGRANEX Gel is becaplermin, a genetically engineered platelet-derived growth factor that mimics a protein that occurs naturally in the body. The growth factor stimulates the migration of cells to the ulcer site, encouraging the patient's body to grow new tissue that heals these open wounds.