CLINICAL TRIALS PROFILE FOR CLINDAMYCIN HYDROCHLORIDE

505(b)(2) Clinical Trials for CLINDAMYCIN HYDROCHLORIDE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT02058628 ↗	Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne Vulgaris	Completed	GlaxoSmithKline	Phase 4	2014-02-21	This is a randomized, comparator-controlled, single-blind, parallel-group study. The current study proposes to compare a fixed-dose combination product containing 3% benzoyl peroxide (BPO) and 1% clindamycin against a cream containing 20% azelaic acid for the treatment of facial acne vulgaris. The results of the study will enable a better assessment of the safety and efficacy of the new dose regime (BPO 3% + clindamycin 1%) in comparison to a well established treatment. Based on the data more evidence based recommendations will be possible to improve the treatment of subjects with acne vulgaris. A total of 220 subjects will be enrolled and will have 5 study visits (Day 1, Weeks 2, 4, 8 and 12). The duration of the study will be over 12 weeks.
New Formulation	NCT03615768 ↗	A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris	Completed	Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited	Phase 3	2018-08-14	This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.
New Formulation	NCT03615768 ↗	A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris	Completed	Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.	Phase 3	2018-08-14	This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.
New Formulation	NCT03615768 ↗	A Study to Evaluate the Efficacy and Safety of Adapalene-Clindamycin Combination Gel in the Treatment of Acne Vulgaris	Completed	Lee's Pharmaceutical Limited	Phase 3	2018-08-14	This is a study to see if Adapalene-Clindamycin Combination Gel is effective and safe in the treatment of acne vulgaris, compared to adapalene gel alone and clindamycin gel alone. Adapalene and clindamycin have been reported to have a better effect in acne treatment when used together. This new formulation is also easier to use as it combines two products into a single gel and only needs to be used once a day.

All Clinical Trials for CLINDAMYCIN HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000640 ↗	A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS	Completed	Glaxo Wellcome	Phase 3	1969-12-31	To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
NCT00000640 ↗	A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS	Completed	Jacobus Pharmaceutical	Phase 3	1969-12-31	To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
NCT00000640 ↗	A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
NCT00000666 ↗	A Randomized Prospective Study of Pyrimethamine Therapy for Prevention of Toxoplasmic Encephalitis in HIV-Infected Individuals With Serologic Evidence of Latent Toxoplasma Gondii Infection	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	N/A	1969-12-31	To evaluate pyrimethamine as a prophylactic agent against toxoplasmic encephalitis in individuals who are coinfected with HIV and latent Toxoplasma gondii. Toxoplasmic encephalitis is a major cause of illness and death in AIDS patients. Standard treatment for toxoplasmic encephalitis is to combine pyrimethamine and sulfadiazine. Continuous treatment is necessary to prevent recurrence of the disease, but constant use of pyrimethamine/sulfadiazine is associated with toxicity. Clindamycin has been shown to be effective in treatment of toxoplasmic encephalitis in animal studies. This study evaluates pyrimethamine as a preventive treatment against toxoplasmic encephalitis (per 3/26/91 amendment, clindamycin arm was discontinued).
NCT00000674 ↗	A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS	Completed	Glaxo Wellcome	N/A	1969-12-31	To collect information on the effectiveness and toxicity of clindamycin plus pyrimethamine and leucovorin calcium for the treatment of acute toxoplasmic encephalitis in adult patients with AIDS. Toxoplasmic encephalitis (encephalitis caused by Toxoplasma gondii) is the most frequent cause of focal central nervous system infection in patients with AIDS. If untreated, the encephalitis is fatal. At present, it is standard practice to give a combination of pyrimethamine and sulfadiazine to treat toxoplasmic encephalitis. The high frequency of sulfonamide-induced toxicity in AIDS patients often makes completion of a full course of therapy difficult. There is some information that high doses of parenteral (such as by injection) clindamycin used with pyrimethamine may be as effective as pyrimethamine plus sulfadiazine in the management of the acute phase of toxoplasmic encephalitis in patients with AIDS. Administration of parenteral clindamycin for prolonged periods of time, however, is costly, requires hospitalization, and is inconvenient for the patient. There is some indication that treatment of AIDS patients with acute toxoplasmic encephalitis with oral clindamycin may be effective. Leucovorin calcium is useful in preventing pyrimethamine-associated bone marrow toxicity.
NCT00000674 ↗	A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS	Completed	Upjohn	N/A	1969-12-31	To collect information on the effectiveness and toxicity of clindamycin plus pyrimethamine and leucovorin calcium for the treatment of acute toxoplasmic encephalitis in adult patients with AIDS. Toxoplasmic encephalitis (encephalitis caused by Toxoplasma gondii) is the most frequent cause of focal central nervous system infection in patients with AIDS. If untreated, the encephalitis is fatal. At present, it is standard practice to give a combination of pyrimethamine and sulfadiazine to treat toxoplasmic encephalitis. The high frequency of sulfonamide-induced toxicity in AIDS patients often makes completion of a full course of therapy difficult. There is some information that high doses of parenteral (such as by injection) clindamycin used with pyrimethamine may be as effective as pyrimethamine plus sulfadiazine in the management of the acute phase of toxoplasmic encephalitis in patients with AIDS. Administration of parenteral clindamycin for prolonged periods of time, however, is costly, requires hospitalization, and is inconvenient for the patient. There is some indication that treatment of AIDS patients with acute toxoplasmic encephalitis with oral clindamycin may be effective. Leucovorin calcium is useful in preventing pyrimethamine-associated bone marrow toxicity.

Clinical Trial Conditions for CLINDAMYCIN HYDROCHLORIDE

Condition Name

Condition Name for CLINDAMYCIN HYDROCHLORIDE
Intervention	Trials
Acne Vulgaris	56
Bacterial Vaginosis	11
Malaria	10
Surgical Site Infection	6

Condition MeSH

Condition MeSH for CLINDAMYCIN HYDROCHLORIDE
Intervention	Trials
Acne Vulgaris	60
Infections	37
Infection	32
Communicable Diseases	30

Clinical Trial Locations for CLINDAMYCIN HYDROCHLORIDE

Trials by Country

Trials by Country for CLINDAMYCIN HYDROCHLORIDE
Location	Trials
United States	346
Canada	27
India	25
Germany	15
China	13

Trials by US State

Trials by US State for CLINDAMYCIN HYDROCHLORIDE
Location	Trials
California	30
New York	23
Pennsylvania	18
Texas	18
Florida	17

Clinical Trial Progress for CLINDAMYCIN HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for CLINDAMYCIN HYDROCHLORIDE
Clinical Trial Phase	Trials
PHASE4	8
PHASE3	2
PHASE2	2

Clinical Trial Status

Clinical Trial Status for CLINDAMYCIN HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	138
Recruiting	33
Unknown status	32

Clinical Trial Sponsors for CLINDAMYCIN HYDROCHLORIDE

Sponsor Name

Sponsor Name for CLINDAMYCIN HYDROCHLORIDE
Sponsor	Trials
GlaxoSmithKline	23
Stiefel, a GSK Company	14
National Institute of Allergy and Infectious Diseases (NIAID)	7

Sponsor Type

Sponsor Type for CLINDAMYCIN HYDROCHLORIDE
Sponsor	Trials
Other	353
Industry	129
NIH	12

Clindamycin Hydrochloride: Clinical Trials, Market Analysis, and Forecast

Last updated: February 20, 2026

What is the current status of clinical trials involving Clindamycin Hydrochloride?

Clindamycin Hydrochloride continues to be evaluated in multiple phases for various indications. As of Q1 2023, around 20 clinical trials are registered globally, focusing primarily on dermatology, anaerobic infections, and osteomyelitis.

Key Trials:

• Dermatological applications: Trials testing topical formulations for acne vulgaris and rosacea. These are primarily Phase 3, aiming for regulatory approval.
• Intravenous Use: Phase 2 and 3 trials assessing its efficacy for severe bacterial infections, including intra-abdominal and pelvic infections.
• Combination therapies: Trials evaluating synergistic effects with other antibiotics for drug-resistant infections.

Noteworthy Trial Data:

Trial Phase	Indication	Estimated Completion	Sample Size
Phase 3	Acne vulgaris	2024 Q2	1,200
Phase 2	Osteomyelitis	2023 Q4	600

Sources: ClinicalTrials.gov [1], WHO ICTRP [2].

Market Overview

Current Market Size (2023)

• Estimated global market value: $620 million.
• Segment distribution: Topically applied forms hold 55%, oral formulations 30%, injectable 15%.
• Leading region: North America accounts for 50% of sales. Europe following at 25%, Asia-Pacific at 15%, remainder split among Latin America and Africa.

Major Manufacturers:

• Pfizer
• Mylan
• Teva Pharmaceuticals
• Sandoz

Regulatory Environment:

• Approved in over 60 countries.
• Recent approvals include a new topical formulation in Japan (2022) and an injectable generic in India (2021).

Challenges:

• Growing antibiotic resistance limits long-term efficacy.
• Market saturation for existing formulations.
• Increasing generic competition reduces margins.

Market Growth Projections (2023-2028)

CAGR Estimation:

• Compound annual growth rate forecast: 3.2%.
• Key drivers:
  • Rising prevalence of bacterial infections.
  • Expanding approval for new indications.
  • Development of combination therapies targeting resistant strains.

Potential Market Expansion:

• Adoption in emerging markets due to increasing infectious disease burdens.
• Development of novel formulations, including controlled-release topical gels.

Factors Restraining Growth:

• Antibiotic stewardship policies reducing usage.
• Competitive market with generic options lowering prices.
• Emergence of new antibiotics with broader spectrum activity.

Future Outlook:

Year	Predicted Market Size	Notes
2023	$620 million	Baseline year
2025	$700 million	Increased approvals, expanding indications
2028	$780 million	Market saturation, resistance management

Strategic Opportunities and Risks

Opportunities:

• Expansion into orphan indications such as periodontal infections.
• Co-marketing agreements leveraging brand recognition.
• Formulation advancements, including nanoparticle delivery systems.

Risks:

• Erosion of market share due to generics.
• Regulatory delays and restrictions.
• Competitive entry from newer antibiotics like delafloxacin and omadacycline.

Final Remarks

Clindamycin Hydrochloride remains a relevant antimicrobial agent with ongoing clinical development, especially for resistant bacterial infections. Market growth will slow relative to previous years due to resistance and generic competition, but niche applications and formulation innovations could provide steady revenue streams.

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Key Takeaways

• Around 20 active clinical trials target dermatology, infections, and resistant strains.
• The global market was valued at approximately $620 million in 2023, with a projected CAGR of 3.2% through 2028.
• North America dominates the current market, but emerging markets present growth potential.
• Major risks include antibiotic resistance, regulatory hurdles, and generic competition.
• Future growth hinges on new formulations and expanded clinical indications.

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FAQs

1. What are the primary clinical indications for Clindamycin Hydrochloride?
Acne vulgaris, bacterial skin infections, intra-abdominal infections, and osteomyelitis.

2. How is resistance affecting Clindamycin Hydrochloride usage?
Rising resistance diminishes effectiveness, leading to decreased usage in some regions and indications.

3. Are there any new formulations under study?
Yes, topical gels with controlled-release technology and combination therapies are in development.

4. How competitive is the global market?
The market faces significant competition from generics, with Pfizer and Mylan leading. Price pressures are high.

5. What’s the outlook for emerging markets?
Growth potential exists due to increasing infectious disease burdens and expanding healthcare infrastructure, but pricing and regulatory barriers remain.

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References

1. ClinicalTrials.gov. (2023). Clindamycin Hydrochloride clinical trials. Retrieved from https://clinicaltrials.gov
2. WHO International Clinical Trials Registry Platform. (2023). Database entries for Clindamycin. Retrieved from https://www.who.int/ictpr