Last reviewed · How we verify
Clindamycin 2-Palmitate (CLINDAMYCIN PALMITATE)
Clindamycin Palmitate, marketed by Pfizer, is an established antibiotic that inhibits bacterial protein synthesis, effectively treating a range of infections. Its key strength lies in its well-established mechanism and market presence, supported by a key composition patent expiring in 2028. The primary risk is the potential increase in competition as the patent approaches expiration.
At a glance
| Generic name | CLINDAMYCIN PALMITATE |
|---|---|
| Sponsor | Pfizer |
| Drug class | Lincosamide Antibacterial |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1986 |
Approved indications
Boxed warnings
- WARNING Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.difficile . Because clindamycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. C.difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C.difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.difficile , and surgical evaluation should be instituted as clinically indicated.
Common side effects
- Clostridium difficile colitis
- Pseudomembranous colitis
- Abdominal pain
- Nausea
- Vomiting
- Diarrhea
- Generalized mild to moderate morbilliform-like (maculopapular) skin rashes
- Vesiculobullous rashes
- Urticaria
- Toxic Epidermal Necrolysis
- Acute Generalized Exanthematous Pustulosis (AGEP)
- Erythema multiforme
Key clinical trials
- Immediate Restoration of a New Implant With High Primary Stability (NA)
- Utility of Single-dose Oral Antibiotic Prophylaxis in Prevention of Surgical Site Infection in Dermatologic Surgery (PHASE4)
- Preoperative Clindamycin Vaginal Cream Versus Vaginal Cleansing With Povidone-iodine on Postoperative Infections After Cesarean Section (PHASE4)
- Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib (PHASE2)
- Dual vs. Single-Antibiotic Impregnated Cement in Hemiarthroplasty for Femoral Neck Fracture (PHASE3)
- Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP (PHASE4)
- Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis (PHASE4)
- Evaluation of Topical Dutasteride as a Potential New Therapy for Facial Acne Vulgaris Versus the Triple Combination Therapy (Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel) (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:
- Clindamycin 2-Palmitate CI brief — competitive landscape report
- Clindamycin 2-Palmitate updates RSS · CI watch RSS
- Pfizer portfolio CI