CLINICAL TRIALS PROFILE FOR CEPHALEXIN

All Clinical Trials for Cephalexin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003824 ↗	S9809, Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer	Terminated	National Cancer Institute (NCI)	Phase 3	1999-04-01	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known whether ciprofloxacin is more effective than cephalexin in preventing cancer recurrence in patients who are undergoing surgery to treat bladder cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of ciprofloxacin with that of cephalexin in preventing recurrence of cancer in patients who are undergoing surgery for bladder cancer.
NCT00003824 ↗	S9809, Ciprofloxacin Compared With Cephalexin in Treating Patients With Bladder Cancer	Terminated	Southwest Oncology Group	Phase 3	1999-04-01	RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known whether ciprofloxacin is more effective than cephalexin in preventing cancer recurrence in patients who are undergoing surgery to treat bladder cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of ciprofloxacin with that of cephalexin in preventing recurrence of cancer in patients who are undergoing surgery for bladder cancer.
NCT00179959 ↗	The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis	Completed	Johnson & Johnson	Phase 4	2005-09-01	Staphylococcus aureus (S. aureus) infection is perceived not only as a common secondary complication of atopic dermatitis (AD), but also as a culprit in the worsening of this condition. In addition, the recent development of community acquired methicillin-resistant S. aureus (CA-MRSA) has presented a new challenge to our management of AD, both in treatment of acute infections and maintenance therapy. The investigators would like to perform a randomized investigator-blinded placebo-controlled study of children aged 6 months to 17 years with moderate to severe atopic dermatitis with clinical signs of secondary bacterial infection to study: 1) the prevalence of CA-MRSA in our patient population; 2) the relationship of sensitivity of the S. aureus organism cultured from the infected lesion(s) to clinical response to oral cephalexin therapy and severity of the AD; and 3) whether concurrent treatment of S. aureus infection initially with nasal mupirocin ointment and sodium hypochlorite (bleach) baths can result in long-term S. aureus eradication and clinical stability.
NCT00179959 ↗	The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis	Completed	Society for Pediatric Dermatology	Phase 4	2005-09-01	Staphylococcus aureus (S. aureus) infection is perceived not only as a common secondary complication of atopic dermatitis (AD), but also as a culprit in the worsening of this condition. In addition, the recent development of community acquired methicillin-resistant S. aureus (CA-MRSA) has presented a new challenge to our management of AD, both in treatment of acute infections and maintenance therapy. The investigators would like to perform a randomized investigator-blinded placebo-controlled study of children aged 6 months to 17 years with moderate to severe atopic dermatitis with clinical signs of secondary bacterial infection to study: 1) the prevalence of CA-MRSA in our patient population; 2) the relationship of sensitivity of the S. aureus organism cultured from the infected lesion(s) to clinical response to oral cephalexin therapy and severity of the AD; and 3) whether concurrent treatment of S. aureus infection initially with nasal mupirocin ointment and sodium hypochlorite (bleach) baths can result in long-term S. aureus eradication and clinical stability.
NCT00179959 ↗	The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis	Completed	Northwestern University	Phase 4	2005-09-01	Staphylococcus aureus (S. aureus) infection is perceived not only as a common secondary complication of atopic dermatitis (AD), but also as a culprit in the worsening of this condition. In addition, the recent development of community acquired methicillin-resistant S. aureus (CA-MRSA) has presented a new challenge to our management of AD, both in treatment of acute infections and maintenance therapy. The investigators would like to perform a randomized investigator-blinded placebo-controlled study of children aged 6 months to 17 years with moderate to severe atopic dermatitis with clinical signs of secondary bacterial infection to study: 1) the prevalence of CA-MRSA in our patient population; 2) the relationship of sensitivity of the S. aureus organism cultured from the infected lesion(s) to clinical response to oral cephalexin therapy and severity of the AD; and 3) whether concurrent treatment of S. aureus infection initially with nasal mupirocin ointment and sodium hypochlorite (bleach) baths can result in long-term S. aureus eradication and clinical stability.
NCT00187759 ↗	Placebo Controlled Study of Antibiotic Treatment of Soft Tissue Infection	Completed	University of California, San Francisco	N/A	2004-11-01	This study is to determine whether antibiotic therapy is needed for patients with non-life threatening soft tissue infections. Most patients with these soft tissue infections are presently treated with antibiotics. Many of these infections resolve without proper antibiotic treatment. Treatment of patients with antibiotics after surgical drainage of an abscess may not be necessary and indiscriminate use of antibiotics may lead to colonization by drug-resistant organisms. Subsequent infection by drug resistant organisms may limit the choice of antibiotics in more complicated infections. A comparison between antibiotic treatment and no antibiotic treatment in surgically treated, uncomplicated soft tissue infections is needed to address this very important question.

Clinical Trial Conditions for Cephalexin

Condition Name

Condition Name for Cephalexin
Intervention	Trials
Cellulitis	6
Surgical Site Infection	5
Healthy Volunteers	4
Anti-Infective Agents	4

Condition MeSH

Condition MeSH for Cephalexin
Intervention	Trials
Infections	12
Infection	11
Communicable Diseases	9
Surgical Wound Infection	8

Clinical Trial Locations for Cephalexin

Trials by Country

Trials by Country for Cephalexin
Location	Trials
United States	73
France	14
Canada	8
Mexico	8
Brazil	3

Trials by US State

Trials by US State for Cephalexin
Location	Trials
California	8
Pennsylvania	7
Maryland	4
Texas	4
New York	4

Clinical Trial Progress for Cephalexin

Clinical Trial Phase

Clinical Trial Phase for Cephalexin
Clinical Trial Phase	Trials
Phase 4	19
Phase 3	4
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Cephalexin
Clinical Trial Phase	Trials
Completed	31
Recruiting	10
Not yet recruiting	7

Clinical Trial Sponsors for Cephalexin

Sponsor Name

Sponsor Name for Cephalexin
Sponsor	Trials
Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.	5
Eli Lilly and Company	5
National Institute of Allergy and Infectious Diseases (NIAID)	3

Sponsor Type

Sponsor Type for Cephalexin
Sponsor	Trials
Other	91
Industry	21
NIH	6

Cephalexin: Clinical Trials, Market Analysis, and Projections

Clinical Trials Update

Recent Studies on Cephalexin Efficacy

One of the most significant clinical trials involving cephalexin was a multicenter, double-blind, randomized superiority trial conducted to determine whether adding trimethoprim-sulfamethoxazole to cephalexin enhances the clinical cure rate for uncomplicated cellulitis.

• Methodology and Participants: The trial enrolled 500 outpatients older than 12 years with cellulitis, recruited from five US emergency departments between April 2009 and June 2012. Participants were randomized to receive either cephalexin plus trimethoprim-sulfamethoxazole or cephalexin plus placebo for 7 days[1].
• Outcomes: The study found that the clinical cure rates were not significantly different between the two groups. In the per-protocol analysis, the cure rates were 83.5% for the cephalexin plus trimethoprim-sulfamethoxazole group and 85.5% for the cephalexin alone group. The modified intention-to-treat analysis showed cure rates of 76.2% and 69.0%, respectively. The difference in the intention-to-treat analysis was not statistically significant, although it included the minimal clinically important difference of 10%[1].

Implications of the Study

The study suggests that, for uncomplicated cellulitis, the addition of trimethoprim-sulfamethoxazole to cephalexin may not provide a significant clinical benefit. This finding is crucial for guiding treatment protocols and optimizing antibiotic use.

Market Analysis

Global Market Size and Growth

The global cephalexin market is experiencing significant growth driven by several factors, including the increasing prevalence of bacterial infections and advancements in pharmaceutical technology.

• Current Market Size: As of 2024, the global cephalexin API market size is estimated to be in the millions of USD, with North America holding a major share of around 40% of the global revenue[2].
• Growth Projections: The market is expected to expand at a compound annual growth rate (CAGR) of 6.30% from 2024 to 2031. This growth is attributed to the stringent regulatory standards, emphasis on research and development, and strategic collaborations between pharmaceutical companies and research institutions[2].

Regional Market Dynamics

North America

• North America dominates the cephalexin API market due to its advanced healthcare infrastructure and stringent regulatory standards. The region's focus on research and development and the preference for advanced healthcare solutions, such as injection technologies, drive market growth[2].

Asia Pacific

• The Asia Pacific region is a key growth market, driven by rapid urbanization, increasing incidence of bacterial infections, and the expanding pharmaceutical industry. The powder injection segment is the fastest-growing in this region due to its advantages in solubility, stability, and cost-effectiveness[2].

Latin America

• Latin America is experiencing growing demand for cephalexin API, driven by expanding healthcare infrastructure, rising awareness of infectious diseases, and favorable regulatory environments. The 99.5% purity segment holds the highest market share due to its ease of administration and widespread availability[2].

Middle East and Africa

• In the Middle East and Africa, increasing healthcare expenditure and government initiatives to improve healthcare access are driving cephalexin API sales. The region's growing population and urbanization also contribute to the demand for antibiotics[2].

Market Segmentation

By Formulation

• The global cephalexin market is segmented by formulation into capsules, liquid suspension, and tablets. Each formulation has its own market share and growth prospects, with tablets being a commonly used form due to their ease of administration and stability[3].

By Distribution Channel

• The market is also segmented by distribution channel into retail pharmacies, online pharmacies, and hospital pharmacies. Retail pharmacies remain a dominant channel due to their widespread presence and consumer preference[3].

Market Drivers and Restraints

Drivers

• Increasing Prevalence of Bacterial Infections: The rising incidence of bacterial infections globally is a significant driver for the cephalexin market. As populations grow and urbanization increases, the demand for effective antibiotics like cephalexin is expected to rise[3].
• Advancements in Pharmaceutical Technology: Continuous advancements in drug formulations and delivery systems, such as improved injection technologies, are driving market growth[2].

Restraints

• Availability in Emerging Nations: The availability of cephalexin in emerging nations can be limited due to various factors, including regulatory hurdles and distribution challenges, which can hamper market growth[3].

Projections and Future Trends

Market Size Projections

• By 2031, the global cephalexin market is expected to reach a significant size, driven by the CAGR of 6.30% from 2024 to 2031. The market size in 2023 was estimated in millions of USD, and this is expected to grow substantially over the forecast period[2][3].

Future Trends

• Increased Focus on Research and Development: The market is likely to see increased investment in research and development, leading to more innovative drug formulations and delivery systems.
• Growing Demand in Emerging Markets: Emerging markets, particularly in Asia Pacific and Latin America, are expected to drive significant growth due to expanding healthcare infrastructure and rising demand for antibiotics[2][3].

Key Takeaways

• The addition of trimethoprim-sulfamethoxazole to cephalexin does not significantly improve clinical cure rates for uncomplicated cellulitis.
• The global cephalexin market is growing at a CAGR of 6.30% from 2024 to 2031, driven by increasing bacterial infections and pharmaceutical advancements.
• North America, Asia Pacific, Latin America, and the Middle East and Africa are key regions driving market growth.
• Market segmentation by formulation and distribution channel highlights the dominance of tablets and retail pharmacies.
• Future trends include increased R&D investment and growing demand in emerging markets.

FAQs

What is the current clinical evidence on the efficacy of cephalexin plus trimethoprim-sulfamethoxazole for cellulitis?

The clinical trial evidence suggests that adding trimethoprim-sulfamethoxazole to cephalexin does not result in a statistically significant improvement in clinical cure rates for uncomplicated cellulitis[1].

What is the projected growth rate of the global cephalexin market?

The global cephalexin market is expected to grow at a CAGR of 6.30% from 2024 to 2031[2].

Which regions are driving the growth of the cephalexin market?

North America, Asia Pacific, Latin America, and the Middle East and Africa are the key regions driving the growth of the cephalexin market[2].

What are the main formulations of cephalexin available in the market?

The main formulations of cephalexin include capsules, liquid suspension, and tablets[3].

What are the primary distribution channels for cephalexin?

The primary distribution channels for cephalexin are retail pharmacies, online pharmacies, and hospital pharmacies[3].

Sources

1. Effect of Cephalexin Plus Trimethoprim-Sulfamethoxazole vs Cephalexin Alone on Clinical Cure of Uncomplicated Cellulitis: A Randomized Clinical Trial. JAMA, 2017.
2. Global Cephalexin API Market Report. Cognitive Market Research, 2024.
3. Cephalexin Market Updates by 2031. The Insight Partners.
4. Cephalexin - Drug Targets, Indications, Patents. Patsnap Synapse.
5. Cephalexin Market Growth: Meeting Global Demand for Antibiotics. Market Research Intellect, 2025.

Last updated: 2025-01-07