Hydrocortisone acetate
- Generic Name
- Hydrocortisone acetate
- Brand Names
- Alcortin A, Analpram HC, Anodan-HC, Anucort-HC, Anusol, Anusol HC, Cortifoam, Cortisporin, Cortisporin-TC, Diphen, Egozinc, Epifoam, Fucidin, Micort-HC, Neo-polycin HC, Nucort, Pramosone, Procort 1.85/1.15, Proctocort, Proctodan-HC, Proctofoam-HC, Rectacort-HC, Rectogel, Riva-sol HC, U-cort, Vagisil, Vytone
- Drug Type
- Small Molecule
- Chemical Formula
- C23H32O6
- CAS Number
- 50-03-3
- Unique Ingredient Identifier
- 3X7931PO74
- Background
Not Available
- Indication
For the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Also used to treat endocrine (hormonal) disorders (adrenal insufficiency, Addisons disease). It is also used to treat many immune and allergic disorders, such as arthritis, lupus, severe psoriasis, severe asthma, ulcerative colitis, and Crohn's disease.
- Associated Conditions
- Acute, Inflammatory Superficial Cutaneous Lesions caused by susceptible bacteria, Adrenocortical Insufficiency, Allergic Conjunctivitis (AC), Anal inflammation, Androgenital syndrome, Conjunctivitis, Dermatitis infected, Diaper Dermatitis, Eczema infected, Episcleritis, Fissure;Anal, Haemorrhoids, Iridocyclitis, Iritis, Keratitis, Ocular Inflammation, Ocular Irritation, Postoperative pain, Proctitis, Pruritus, Pruritus Ani, Radiation Induced Proctitis, Rheumatoid Arthritis, Scleritis, Skin Infections, Skin Irritation, Superficial ocular bacterial infections caused by susceptible bacteria, Thyroiditis, Ulcerative Colitis, Anal eczema, Bacterial blepharitis, Corneal clouding, Corticosteroid responsive Dermatosis of the anal region, Corticosteroid-responsive dermatoses, Cryptitis, Localized uninfected hemorrhoids, Mild Anal Fissures, Pruritus associated with bowel movements, Skin and skin-structure infections caused by susceptible bacteria
- Associated Therapies
- Postoperative Eye Care
Cristcot Announces Positive Phase 3 Results for Novel Hydrocortisone Acetate Suppository in Treating Ulcerative Colitis
Cristcot announced positive Phase 3 trial results for its hydrocortisone acetate suppository in treating ulcerative colitis, achieving clinical remission in 20.2% of patients by Day 29 and rapid clinical response by Day 15. The treatment was well-tolerated, with high patient compliance. NDA submission is planned for Q1 2025.
Cristcot's Phase III ulcerative colitis suppository trial meets endpoints
Cristcot's Phase III trial for a hydrocortisone suppository and applicator showed efficacy in treating ulcerative colitis, achieving clinical remission in 23.0% and 17.5% of patients with once-daily and twice-daily dosing, respectively, compared to 2.1% with placebo. The company plans to submit an NDA to the FDA by early 2025.
Related Clinical Trials:
Clinical Trials Register: Evaluating Hydrocortisone Acetate 90 mg Suppository Efficacy vs. Placebo for Ulcerative Colitis of the Rectum
The trial evaluates hydrocortisone acetate 90 mg suppository's efficacy vs. placebo for ulcerative colitis of the rectum, using the Modified Mayo Score. It includes a pharmacokinetic sub-study to assess drug exposure and HPA axis suppression. The study is double-blind, randomized, and involves multiple sites globally.
Drug Development Updates
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