CLINICAL TRIALS PROFILE FOR CEPHALEXIN HYDROCHLORIDE

All Clinical Trials for Cephalexin Hydrochloride

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.

Clinical Trial Conditions for Cephalexin Hydrochloride

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for Cephalexin Hydrochloride

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for Cephalexin Hydrochloride

Clinical Trial Phase

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

Clinical Trial Status

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

Clinical Trial Sponsors for Cephalexin Hydrochloride

Sponsor Name

Sponsor Name for Cephalexin Hydrochloride
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 Hydrochloride
Sponsor	Trials
Other	91
Industry	21
NIH	6

Cephalexin Hydrochloride: Clinical Trials, Market Analysis, and Projections

Clinical Trials and Efficacy

Recent Clinical Trials on Cephalexin Hydrochloride

A significant clinical trial that sheds light on the efficacy of cephalexin hydrochloride is the multicenter, double-blind, randomized superiority trial conducted to compare the effectiveness of cephalexin plus trimethoprim-sulfamethoxazole versus cephalexin alone in treating uncomplicated cellulitis.

• This study, which enrolled outpatients from five US emergency departments between 2009 and 2012, found that adding trimethoprim-sulfamethoxazole to cephalexin did not result in a statistically significant improvement in clinical cure rates for uncomplicated cellulitis. The clinical cure rates were 83.5% for the cephalexin plus trimethoprim-sulfamethoxazole group and 85.5% for the cephalexin alone group[1].

Comparative Studies

Other studies have compared the efficacy and safety of cephalexin hydrochloride with cephalexin monohydrate. Two prospective, randomized multicenter double-blind studies showed that cephalexin hydrochloride is as effective and safe as cephalexin monohydrate for treating skin and soft tissue infections, including abscesses, cellulitis, and wound infections. The response rates were high in both groups, with 95.7% and 96.5% of patients responding satisfactorily to cephalexin hydrochloride in the two studies, respectively, compared to 90% and 94% for cephalexin monohydrate[3].

Market Analysis

Global Market Size and Growth

The global cephalexin API market is experiencing significant growth driven by several factors:

• North America: This region holds a major share of the global market, approximately 40%, and is expected to grow at a CAGR of 4.5% from 2024 to 2031. The growth is attributed to the region's robust healthcare infrastructure, stringent regulatory standards, and emphasis on research and development[2].

• Europe: Europe accounts for around 30% of the global market and is projected to grow at a CAGR of 4.8% from 2024 to 2031. The growing geriatric population, increased healthcare expenditure, and government initiatives to combat antimicrobial resistance are key drivers[2].

• Asia Pacific: This region is emerging as a key growth market with a CAGR of 8.3% from 2024 to 2031. Rapid urbanization, increasing incidence of bacterial infections, and expanding access to healthcare services are driving the market growth[2].

• Latin America and Middle East & Africa: These regions also show promising growth, with Latin America expected to grow at a CAGR of 5.7% and the Middle East & Africa at a CAGR of 6.0% from 2024 to 2031. The growth in these regions is driven by expanding healthcare infrastructure, increasing awareness of infectious diseases, and favorable regulatory environments[2].

Market Segmentation

The global cephalexin market is segmented by formulation and distribution channel:

• Formulation: The market includes capsules, liquid suspension, and tablets. The injection segment, particularly in North America, is notable for its convenience and efficacy[2][5].

• Distribution Channel: The market is segmented into retail pharmacies, online pharmacies, and hospital pharmacies. Each channel plays a significant role in the distribution and accessibility of cephalexin[5].

Market Dynamics

The growth of the cephalexin market is driven by several factors:

• Increasing Prevalence of Bacterial Infections: The rising incidence of bacterial infections globally is a major driver of the market[5].

• Advancements in Healthcare: Improvements in healthcare infrastructure, especially in regions like North America and Europe, contribute to the market growth[2].

• Regulatory Standards: Stringent regulatory standards ensure the quality of cephalexin API, which is crucial for market expansion[2].

• Research and Development: Continuous innovation in drug formulations and delivery systems, such as advanced injection technologies, further propels the market[2].

Projections and Future Trends

Market Size and Growth Rate

The global cephalexin market is expected to witness significant growth from 2024 to 2031. The market size is projected to increase substantially, driven by the increasing demand for antibiotics to treat various bacterial infections.

• CAGR: The global CAGR for the cephalexin market is expected to be around 5-6% from 2024 to 2031, depending on the region and market segment[2][5].

Regional Growth

Each region is expected to contribute to the overall growth of the cephalexin market:

• North America: Will continue to be a dominant market due to its robust healthcare infrastructure and research-oriented environment[2].

• Europe: Will see steady growth driven by the geriatric population and government initiatives against antimicrobial resistance[2].

• Asia Pacific: Will emerge as a key growth market due to rapid urbanization and increasing healthcare access[2].

• Latin America and Middle East & Africa: Will experience growth driven by expanding healthcare infrastructure and increasing awareness of infectious diseases[2].

Challenges and Opportunities

Despite the positive projections, the market faces some challenges:

• Availability in Emerging Nations: The availability of cephalexin in emerging nations is anticipated to be a challenge, potentially hampering market growth[5].

• Antimicrobial Resistance: The increasing concern over antimicrobial resistance could impact the long-term growth of the cephalexin market, necessitating continuous innovation and regulatory support[2].

Key Takeaways

• Clinical Efficacy: Cephalexin hydrochloride has been shown to be effective and safe in treating various bacterial infections, comparable to other formulations of cephalexin.
• Market Growth: The global cephalexin market is expected to grow significantly from 2024 to 2031, driven by increasing bacterial infections and advancements in healthcare.
• Regional Dynamics: North America, Europe, and Asia Pacific will be key regions driving the market growth, with each region having unique drivers and challenges.
• Market Segmentation: The market is segmented by formulation and distribution channel, with the injection segment and retail pharmacies being significant contributors.

FAQs

What is the primary use of cephalexin hydrochloride?

Cephalexin hydrochloride is primarily used to treat various bacterial infections, including respiratory tract infections, skin and skin structure infections, bone infections, and genitourinary infections[4].

What are the key regions driving the growth of the cephalexin market?

The key regions driving the growth of the cephalexin market include North America, Europe, and Asia Pacific, with each region having its unique drivers such as robust healthcare infrastructure, growing geriatric population, and rapid urbanization[2].

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

The main formulations of cephalexin available in the market include capsules, liquid suspension, and tablets, with the injection segment being particularly notable for its convenience and efficacy[2][5].

What are the challenges facing the cephalexin market?

The challenges facing the cephalexin market include the availability of the product in emerging nations and the increasing concern over antimicrobial resistance[5].

How is the cephalexin market segmented?

The cephalexin market is segmented by formulation (capsules, liquid suspension, tablets) and distribution channel (retail pharmacies, online pharmacies, hospital pharmacies)[5].

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. Comparative study of cephalexin hydrochloride and cephalexin monohydrate in the treatment of skin and soft tissue infections. PubMed, 1988.
4. Cephalexin - Drug Targets, Indications, Patents. Patsnap Synapse.
5. Cephalexin Market Updates by 2031. The Insight Partners.