CLINICAL TRIALS PROFILE FOR METRONIDAZOLE HYDROCHLORIDE

505(b)(2) Clinical Trials for METRONIDAZOLE 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 Formulation	NCT01559545 ↗	A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis	Completed	Reliance Clinical Research Services (Navi Mumbai, India)	Phase 2	2012-03-01	Clostridium difficile bacteria can be a cause of significant diarrheal disease, particularly in people who have taken potent antibiotics. When C. difficile multiplies within the colon, it produces two toxins that cause inflammation and resultant abdominal pain, fever and diarrhea. Current treatment of mild to moderate disease is with immediate release metronidazole, an antibiotic that kills C. difficile. Dr. Reddy's Laboratories has developed a delayed release form of metronidazole to release just before the colon to increase the concentration of antibiotic in the colon to improve the effectiveness of metronidazole treatment and potentially to allow less whole body exposure to the antibiotic. This study will measure the amount of metronidazole in the blood and stool of patients with C. difficile associated diarrhea (CDAD) to confirm that the new formulations are releasing the antibiotic as designed, immediately before the colon.
New Formulation	NCT01559545 ↗	A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis	Completed	Dr. Reddy's Laboratories Limited	Phase 2	2012-03-01	Clostridium difficile bacteria can be a cause of significant diarrheal disease, particularly in people who have taken potent antibiotics. When C. difficile multiplies within the colon, it produces two toxins that cause inflammation and resultant abdominal pain, fever and diarrhea. Current treatment of mild to moderate disease is with immediate release metronidazole, an antibiotic that kills C. difficile. Dr. Reddy's Laboratories has developed a delayed release form of metronidazole to release just before the colon to increase the concentration of antibiotic in the colon to improve the effectiveness of metronidazole treatment and potentially to allow less whole body exposure to the antibiotic. This study will measure the amount of metronidazole in the blood and stool of patients with C. difficile associated diarrhea (CDAD) to confirm that the new formulations are releasing the antibiotic as designed, immediately before the colon.

All Clinical Trials for METRONIDAZOLE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00003151 ↗	Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma	Completed	University of Glasgow	Phase 2	1997-09-01	RATIONALE: Antibiotics may stop the growth of Helicobacter pylori which may be associated with gastric lymphoma. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy in treating patients with low grade gastric lymphoma that has not been previously treated.
NCT00003151 ↗	Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 2	1997-09-01	RATIONALE: Antibiotics may stop the growth of Helicobacter pylori which may be associated with gastric lymphoma. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy in treating patients with low grade gastric lymphoma that has not been previously treated.
NCT00002682 ↗	Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach	Completed	National Cancer Institute (NCI)	Phase 2	1995-08-10	RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
NCT00002682 ↗	Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach	Completed	M.D. Anderson Cancer Center	Phase 2	1995-08-10	RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of the stomach. These treatments may also have an effect on gastric MALT lymphoma of the stomach. PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin, clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma of the stomach.
NCT00021671 ↗	Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission	Completed	National Institute of Mental Health (NIMH)	Phase 3	1969-12-31	The purpose of this study is to see if antibiotic drugs given to treat an infection of the uterus during pregnancy can reduce the chances of HIV being passed from an HIV-positive mother to her baby. A link between bacterial disease of the vagina, premature birth, infection of the uterus during pregnancy, and the passing of HIV from a mother to her baby has been found. Early treatment of these problems may reduce the risk of passing HIV from an HIV-positive mother to her baby. [Note: As of 02/21/03, enrollment into this study was halted because preliminary data showed that the study antibiotics were not effective in preventing mother-to-child HIV transmission.]
NCT00021671 ↗	Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission	Completed	National Institute on Drug Abuse (NIDA)	Phase 3	1969-12-31	The purpose of this study is to see if antibiotic drugs given to treat an infection of the uterus during pregnancy can reduce the chances of HIV being passed from an HIV-positive mother to her baby. A link between bacterial disease of the vagina, premature birth, infection of the uterus during pregnancy, and the passing of HIV from a mother to her baby has been found. Early treatment of these problems may reduce the risk of passing HIV from an HIV-positive mother to her baby. [Note: As of 02/21/03, enrollment into this study was halted because preliminary data showed that the study antibiotics were not effective in preventing mother-to-child HIV transmission.]
NCT00021671 ↗	Antibiotics to Reduce Chorioamnionitis-Related Perinatal HIV Transmission	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	The purpose of this study is to see if antibiotic drugs given to treat an infection of the uterus during pregnancy can reduce the chances of HIV being passed from an HIV-positive mother to her baby. A link between bacterial disease of the vagina, premature birth, infection of the uterus during pregnancy, and the passing of HIV from a mother to her baby has been found. Early treatment of these problems may reduce the risk of passing HIV from an HIV-positive mother to her baby. [Note: As of 02/21/03, enrollment into this study was halted because preliminary data showed that the study antibiotics were not effective in preventing mother-to-child HIV transmission.]

Clinical Trial Conditions for METRONIDAZOLE HYDROCHLORIDE

Condition Name

Condition Name for METRONIDAZOLE HYDROCHLORIDE
Intervention	Trials
Helicobacter Pylori Infection	87
Bacterial Vaginosis	43
Periodontitis	13
Chronic Periodontitis	12

Condition MeSH

Condition MeSH for METRONIDAZOLE HYDROCHLORIDE
Intervention	Trials
Infections	119
Infection	98
Helicobacter Infections	85
Communicable Diseases	80

Clinical Trial Locations for METRONIDAZOLE HYDROCHLORIDE

Trials by Country

+

−

Trials by Country for METRONIDAZOLE HYDROCHLORIDE
Location	Trials
United States	538
China	78
Taiwan	43
Japan	38
Canada	38

Trials by US State

+

−

Trials by US State for METRONIDAZOLE HYDROCHLORIDE
Location	Trials
California	38
Texas	34
North Carolina	26
Ohio	24
Florida	24

Clinical Trial Progress for METRONIDAZOLE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for METRONIDAZOLE HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	196
Phase 3	92
Phase 2/Phase 3	24

Clinical Trial Status

Clinical Trial Status for METRONIDAZOLE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	268
Unknown status	77
Recruiting	75

Clinical Trial Sponsors for METRONIDAZOLE HYDROCHLORIDE

Sponsor Name

Sponsor Name for METRONIDAZOLE HYDROCHLORIDE
Sponsor	Trials
National Taiwan University Hospital	19
Shanghai Jiao Tong University School of Medicine	16
Pfizer	14

Sponsor Type

Sponsor Type for METRONIDAZOLE HYDROCHLORIDE
Sponsor	Trials
Other	670
Industry	163
NIH	24

Metronidazole Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Metronidazole Hydrochloride

Metronidazole hydrochloride is a widely used antimicrobial agent belonging to the nitroimidazole class. It is effective against a range of infections, including trichomoniasis, amebiasis, giardiasis, and various anaerobic bacterial infections. Here, we delve into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Pharmacokinetics and Clinical Justification

Metronidazole exhibits high bioavailability (>90%) upon oral administration, with extensive distribution into bodily fluids and tissues, excluding adipose and placental tissues. It undergoes hepatic metabolism, producing an active hydroxy metabolite with a half-life comparable to that of the parent compound, approximately 8-13 hours[1].

Clinical trials have compared the efficacy of different dosing schedules of metronidazole. For instance, a study by Earl et al. (1986) showed comparable peak serum concentrations between oral 400 mg twice daily (BID) and intravenous 500 mg BID administrations. This suggests that BID dosing can achieve adequate serum levels, similar to those of more frequent dosing regimens[1].

Clinical Non-Inferiority

Lloyd et al. (1994) examined postoperative infection incidence following mandibular third molar removal and found no statistically significant differences in postoperative complications between BID and three times daily (TID) dosing regimens. However, the TID group experienced a higher incidence of nausea, indicating that BID dosing may offer a better side effect profile[1].

Specific Infections

For clostridium difficile infection (CDI), while metronidazole is used, there is a lack of clinical data to support BID dosing specifically for this condition. Clinical trials and market reports highlight the ongoing research and development activities for CDI, including regulatory milestones and other developmental activities[3].

Market Analysis

Market Size and Forecast

The global metronidazole market was valued at USD 101 million in 2023 and is projected to reach USD 139.97 million by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.1% during the forecast period 2024-2031. This growth is driven by factors such as expanding healthcare access in emerging economies, increasing prevalence of infections, and the aging population[5].

Regional Market Dynamics

North America and Europe are significant markets for metronidazole, driven by advanced healthcare infrastructure and a high prevalence of infections. The Asia-Pacific region is also witnessing rapid growth due to increasing healthcare access and rising disposable incomes, particularly in countries like India and China[5].

Distribution Channels

The market is segmented by distribution channels, with retail pharmacies holding the largest market share. Retail pharmacies are preferred due to their accessibility, ensuring prompt and easy access to prescription medications[2].

End Use Segmentation

The human segment dominates the market, driven by the growing demand for novel antibiotics to reduce disease recurrence rates and advancements in healthcare solutions. Veterinary applications also contribute to market growth, although to a lesser extent[2].

Market Projections

Growth Drivers

Several factors are expected to drive the growth of the metronidazole market:

• Regulatory Approvals and Innovations: New formulations and routes of administration, such as extended-release formulations, are being developed and approved, which can stimulate market growth[5].
• Aging Population: An aging demographic is more susceptible to infections, driving the demand for antibiotics like metronidazole[5].
• Increased Veterinary Applications: The use of metronidazole in veterinary medicine is expected to create additional demand[5].
• Global Health Initiatives: Efforts by governments and NGOs to control infectious diseases can boost the demand for effective antibiotics, including metronidazole[5].

Challenges and Opportunities

Despite the growth potential, the market faces challenges such as the emergence of antibiotic-resistant bacterial strains and the availability of generic versions of metronidazole, which can impact market dynamics. However, these challenges also present opportunities for innovation and the development of new therapeutic approaches[5].

Future Market Scenario

Emerging Therapies

The market for clostridium difficile infection is set to change with extensive research and incremental healthcare spending. New therapies focusing on novel approaches to treat CDI are being developed, which will influence the market dominance of metronidazole. Late-stage emerging therapies in the near future will significantly impact the market, providing tough competition to metronidazole[3].

Forecasted Sales

Forecasted sales data from 2023 to 2032 indicate a steady growth trajectory for metronidazole, particularly in the seven major markets including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. This growth will be supported by the overall scenario of metronidazole in treating various infections[3].

Key Takeaways

• Pharmacokinetic Profile: Metronidazole's pharmacokinetic profile supports BID dosing, which is clinically non-inferior to TID dosing for many infections.
• Market Growth: The global metronidazole market is projected to grow at a CAGR of 5.1% from 2024 to 2031.
• Regional Dynamics: North America, Europe, and the Asia-Pacific region are key markets driven by healthcare infrastructure and infection prevalence.
• Growth Drivers: Regulatory approvals, aging population, and global health initiatives are significant growth drivers.
• Challenges and Opportunities: The emergence of antibiotic-resistant strains and generic versions present both challenges and opportunities for innovation.

FAQs

What is the primary mechanism of action of metronidazole?

Metronidazole exerts its antimicrobial effects through the reduction of its nitro group by anaerobic organisms, leading to DNA strand damage in microbes[4].

What are the common side effects of metronidazole?

Common side effects include nausea, particularly with TID dosing, as well as potential neurological effects such as convulsions and neuropathy[1][4].

Can metronidazole be used for clostridium difficile infection (CDI)?

While metronidazole is used for CDI, there is a lack of clinical data to support BID dosing specifically for this condition. Ongoing research is focused on this area[3].

What is the projected market size of metronidazole by 2031?

The global metronidazole market is projected to reach USD 139.97 million by 2031, growing at a CAGR of 5.1% from 2024 to 2031[5].

What are the key distribution channels for metronidazole?

Retail pharmacies hold the largest market share due to their accessibility and convenience for patients to obtain prescription medications[2].

Sources

1. Pharmacy Times: Metronidazole Twice Daily: A Pharmacokinetic and Clinical Justification.
2. Verified Market Research: North America, Europe And Asia-Pacific Metronidazole Market.
3. Research and Markets: Metronidazole Drug Insight and Market Forecast - 2032.
4. DrugBank: Metronidazole: Uses, Interactions, Mechanism of Action.
5. Verified Market Research: Metronidazole Market Size, Share, Scope, Trends & Forecast.