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Cleocin (clindamycin)
Lincosamide antibiotic that binds the 50S ribosomal subunit, inhibiting bacterial protein synthesis with excellent anaerobic coverage.
Clindamycin (Cleocin), a lincosamide antibiotic originally developed by Upjohn/Pfizer and now available as a generic, holds a significant market position in the treatment of acne vulgaris. Its key strength lies in its mechanism of action, binding to the 50S ribosomal subunit to inhibit bacterial protein synthesis, providing excellent anaerobic coverage. The primary risk is the key composition patent expiry in 2028, which may increase competition from other generics.
At a glance
| Generic name | clindamycin |
|---|---|
| Also known as | Cleocin, Dalacin |
| Sponsor | Generic (originally Upjohn/Pfizer) |
| Drug class | Lincosamide antibiotic |
| Target | 50S ribosomal protein L10 |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1970-01-01 (United States) |
Mechanism of action
Clindamycin is notable for excellent penetration into bone and abscesses, and strong activity against anaerobes and gram-positive cocci. The topical formulation is widely used for acne. Its main limitation is the risk of Clostridioides difficile colitis, requiring careful patient selection.
Approved indications
- Acne vulgaris
- Anaerobic Endometritis
- Anaerobic Joint Infection
- Anaerobic Lung Abscess
- Anaerobic Pelvic Cellulitis
- Anaerobic Peritonitis
- Anaerobic Tubo-Ovarian Abscess
- Anaerobic septicemia
- Aspiration pneumonia
- Bacterial septicemia
- Bacterial vaginosis
- Bacteroides Endomyometritis
- Clostridium Perfringens Empyema
- Empyema of pleura
- Gas gangrene caused by clostridium perfringens
- Infection due to Staphylococcus aureus
- Infection due to anaerobic bacteria
- Infection of bone
- Infection of skin AND/OR subcutaneous tissue
- Infectious disease of abdomen
Common side effects
- Morbilliform-like (maculopapular) skin rashes
- Diarrhea
- Nausea
- Vomiting
- Abdominal pain
- Pruritus
- Unpleasant or metallic taste
- Urticaria
- Vesiculobullous rashes
- Vaginitis
- Transient neutropenia (leukopenia)
- Eosinophilia
Serious adverse events
- Clostridioides difficile colitis
- Pseudomembranous colitis
- Toxic Epidermal Necrolysis
- Stevens-Johnson syndrome
- Acute Generalized Exanthematous Pustulosis (AGEP)
- Anaphylactic shock
- Anaphylactic reaction
- Acute kidney injury
- Agranulocytosis
- Drug reaction with eosinophilia and systemic symptoms (DRESS)
Key clinical trials
- Vaginal Colonization After Treatment With Lactobacillus in Women With BV or Candida Will That Increase the Cure Rate After Treatment With Clindamycin for BV and Flucnazole for Candida (N/A)
- Comparison Between Laying Open and Sinus Excision of Pilonidal Sinus - a Randomized Study (NA)
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of GDC 268 and Clindamycin Phosphate Topical Lotion, 1% in Subject (Phase 3)
- Clindamycin to Reduce Preterm Birth in a Low Resource Setting: A Randomized Placebo-controlled Trial (Phase 4)
- A Randomized, Controlled Study to Investigate the Efficacy and Safety of a Topical Gentamicin-Collagen Sponge in Combination With Systemic Antibiotic Therapy in Diabetic Patients With a Moderate or Se (Phase 4)
- A Single-Center, Evaluator-Blinded, Randomized, Placebo Controlled, Phase 1 Clinical Trial Evaluating The Phototoxic Potential Of Topically Applied Clindamycin 1.0% - Tretinoin 0.025% Gel (Ct Gel) In (Phase 1)
- Comparative Antimicrobial Efficacy of Two Topical Acne Therapies for the Treatment of Moderate to Moderately Severe Facial Acne Vulgaris (Phase 4)
- A Randomized, Placebo Controlled Trial of the Effect of Prophylactic Antibiotics on Surgical Site Infection Lower Limb Skin Excisions (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cleocin CI brief — competitive landscape report
- Cleocin updates RSS · CI watch RSS
- Generic (originally Upjohn/Pfizer) portfolio CI