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.
NCT00000674 ↗	A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	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	53
Malaria	10
Bacterial Vaginosis	10
Surgical Site Infection	6

Condition MeSH

Condition MeSH for Clindamycin Hydrochloride
Intervention	Trials
Acne Vulgaris	57
Infections	36
Infection	32
Communicable Diseases	30

Clinical Trial Locations for Clindamycin Hydrochloride

Trials by Country

Trials by Country for Clindamycin Hydrochloride
Location	Trials
United States	342
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	22
Texas	18
Pennsylvania	18
Florida	17

Clinical Trial Progress for Clindamycin Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Clindamycin Hydrochloride
Clinical Trial Phase	Trials
Phase 4	75
Phase 3	47
Phase 2/Phase 3	7

Clinical Trial Status

Clinical Trial Status for Clindamycin Hydrochloride
Clinical Trial Phase	Trials
Completed	132
Unknown status	32
Recruiting	28

Clinical Trial Sponsors for Clindamycin Hydrochloride

Sponsor Name

Sponsor Name for Clindamycin Hydrochloride
Sponsor	Trials
GlaxoSmithKline	22
Stiefel, a GSK Company	14
National Institute of Allergy and Infectious Diseases (NIAID)	7

Sponsor Type

Sponsor Type for Clindamycin Hydrochloride
Sponsor	Trials
Other	310
Industry	123
NIH	12

Clindamycin Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Clindamycin Hydrochloride

Clindamycin hydrochloride is a semi-synthetic lincosamide antibiotic widely used in the treatment of various serious bacterial infections. It works by inhibiting bacterial protein synthesis by binding to the 50S subunit of the bacterial ribosome, thereby impeding the assembly of the ribosome and the translation process[4].

Mechanism of Action

Clindamycin's mechanism involves binding to the 23S RNA of the 50S ribosomal subunit, acting as a structural analog of tRNA molecules. This binding impairs peptide chain initiation and may stimulate the dissociation of peptidyl-tRNA from bacterial ribosomes. This action is effective against a range of susceptible microorganisms, including those causing skin and soft tissue infections, anaerobic infections, and other serious bacterial infections[4].

Clinical Trials and Indications

Active Indications

Clindamycin hydrochloride is actively used in the treatment of several bacterial infections, including:

• Osteomyelitis (bone infections)
• Joint infections
• Pelvic infections
• Skin and soft tissue infections
• Anaerobic infections[1][4].

Ongoing and Recent Clinical Trials

Several clinical trials involving clindamycin hydrochloride are ongoing or have been recently completed. For example:

• Combination Therapies: Trials involving combinations of clindamycin with other antibiotics such as fluoroquinolones, cephalosporins, gentamicin, and ampicillin have been conducted to evaluate their efficacy in treating various infections[1].
• Fecal Microbiota Transplantation (FMT): Studies have explored the use of clindamycin along with neomycin and vancomycin prior to FMT to prepare the gut microbiota[1].
• Surgical Prophylaxis: Clindamycin is often used in surgical prophylaxis to prevent post-surgical infections, and trials continue to evaluate its effectiveness in this context[2][3].

Market Analysis

Current Market Size and Growth

The clindamycin hydrochloride market has experienced strong growth in recent years. As of 2023, the market size was $1.68 billion, and it is expected to grow to $1.82 billion in 2024 at a compound annual growth rate (CAGR) of 8.5%[2][3][5].

Drivers of Growth

Several factors are driving the growth of the clindamycin hydrochloride market:

• Increasing Prevalence of Bacterial Infections: The rising incidence of bacterial infections, including those resistant to other antibiotics, has increased the demand for clindamycin.
• Growing Use in Surgical Prophylaxis: Clindamycin's effectiveness in preventing post-surgical infections has led to its greater adoption in surgical settings.
• Heightened Awareness and Diagnosis: Improved diagnosis and awareness of skin and soft tissue infections have contributed to the increased use of clindamycin.
• Recommendations by Healthcare Professionals: The drug's effectiveness against resistant strains has led to increased recommendations by healthcare professionals[2][3][5].

Market Projections

Future Growth

The clindamycin hydrochloride market is expected to continue its strong growth trajectory. By 2028, the market size is projected to reach $2.54 billion at a CAGR of 8.6%[2][3][5].

Key Trends

Several trends are expected to shape the future of the clindamycin hydrochloride market:

• Advances in Pharmaceutical Formulations: Improvements in formulations and delivery methods, such as topical and combination therapies, will drive growth.
• Growing Demand for Targeted Antibiotics: The increasing demand for antibiotics with fewer side effects will favor clindamycin.
• Increasing Investment in Healthcare Infrastructure: Greater investment in healthcare infrastructure and access to medications will expand the market.
• Rising Prevalence of Antibiotic-Resistant Infections: The global rise in antibiotic-resistant infections will continue to drive the need for effective antibiotics like clindamycin.
• Expanding Use in Emerging Markets: The use of clindamycin is expected to grow in emerging markets, contributing to overall market growth[2][3][5].

Strategic Partnerships and Acquisitions

The market is also expected to benefit from strategic partnerships and acquisitions, which will increase the market presence of clindamycin hydrochloride. These collaborations can lead to the development of new formulations and the expansion of clindamycin's applications, including its use in veterinary medicine[2][3][5].

Conclusion

Clindamycin hydrochloride remains a vital antibiotic in the treatment of various bacterial infections. With its strong mechanism of action, widespread clinical use, and favorable market trends, it is poised for continued growth.

Key Takeaways

• Mechanism of Action: Clindamycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit.
• Clinical Trials: Ongoing trials include combination therapies and use in surgical prophylaxis and FMT.
• Market Size and Growth: The market is expected to grow from $1.68 billion in 2023 to $2.54 billion by 2028 at a CAGR of 8.6%.
• Drivers of Growth: Increasing prevalence of bacterial infections, growing use in surgical prophylaxis, and recommendations by healthcare professionals.
• Future Trends: Advances in pharmaceutical formulations, growing demand for targeted antibiotics, and expanding use in emerging markets.

FAQs

What is the primary mechanism of action of clindamycin hydrochloride?

Clindamycin hydrochloride inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S ribosomal subunit, acting as a structural analog of tRNA molecules[4].

What are the main indications for clindamycin hydrochloride?

Clindamycin hydrochloride is used to treat various bacterial infections, including osteomyelitis, joint infections, pelvic infections, skin and soft tissue infections, and anaerobic infections[1][4].

What is the current market size of clindamycin hydrochloride, and what is its projected growth?

The current market size is $1.68 billion in 2023, and it is projected to grow to $1.82 billion in 2024 and $2.54 billion by 2028 at a CAGR of 8.6%[2][3][5].

What are the key drivers of the growth in the clindamycin hydrochloride market?

Key drivers include the increasing prevalence of bacterial infections, growing use in surgical prophylaxis, heightened awareness and diagnosis of skin and soft tissue infections, and recommendations by healthcare professionals[2][3][5].

What trends are expected to shape the future of the clindamycin hydrochloride market?

Expected trends include advances in pharmaceutical formulations, growing demand for targeted antibiotics, increasing investment in healthcare infrastructure, rising prevalence of antibiotic-resistant infections, and expanding use in emerging markets[2][3][5].

How does clindamycin hydrochloride compare to other antibiotics in terms of side effects?

Clindamycin hydrochloride is often preferred due to its effectiveness and relatively fewer side effects compared to other antibiotics, although it can cause adverse effects such as gastrointestinal disturbances[4].

Sources

1. Synapse: Clindamycin Hydrochloride - Drug Targets, Indications, Patents.
2. GII Research: Clindamycin Hydrochloride Global Market Report 2024.
3. The Business Research Company: Clindamycin Hydrochloride Global Market Report 2024.
4. DrugBank: Clindamycin: Uses, Interactions, Mechanism of Action.
5. EINPresswire: Global Clindamycin Hydrochloride Market Set For 8.6 % Growth, Reaching $2.54 Billion By 2028.