LIKMEZ (metronidazole)
LIKMEZ is indicated for the treatment of Trichomoniasis; Amebiasis; Anaerobic Bacterial Infections; Intra-abdominal Infections; Peritonitis; Intra-abdominal Abscess; Liver Abscess.
How LIKMEZ Works
Metronidazole is a nitroimidazole prodrug that exerts its effects in anaerobic environments. It is reduced by low-redox-potential electron transport proteins to form reactive intermediate metabolites. These intermediates cause DNA strand breakage and inhibit nucleic acid synthesis, resulting in the death of susceptible protozoa and anaerobic bacteria.
Details
- Status
- Prescription
- First Approved
- 2023-09-22
- Patent Cliff
- 2039
- Routes
- ORAL
- Dosage Forms
- SUSPENSION
LIKMEZ Approval History
What LIKMEZ Treats
7 indicationsLIKMEZ is approved for 7 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Trichomoniasis
- Amebiasis
- Anaerobic Bacterial Infections
- Intra-abdominal Infections
- Peritonitis
- Intra-abdominal Abscess
- Liver Abscess
LIKMEZ Boxed Warning
POTENTIAL FOR CARCINOGENICITY Metronidazole has been shown to be carcinogenic in mice and rats [ see Warnings and Precautions (5.1) ] . Avoid unnecessary use of LIKMEZ. Reserve LIKMEZ for use in the following indications: trichomoniasis [see Indications and Usage (1.1) ] , amebiasis [ see Indications and Usage (1.2) ] and anaerobic bacterial infections [ see Indications and Usage (1.3) ]. WARNING: POTENTIAL FOR CARCINOGENICITY See full prescribing information for complete boxed warning. Metronid...
WARNING: POTENTIAL FOR CARCINOGENICITY Metronidazole has been shown to be carcinogenic in mice and rats [ see Warnings and Precautions (5.1) ] . Avoid unnecessary use of LIKMEZ. Reserve LIKMEZ for use in the following indications: trichomoniasis [see Indications and Usage (1.1) ] , amebiasis [ see Indications and Usage (1.2) ] and anaerobic bacterial infections [ see Indications and Usage (1.3) ]. WARNING: POTENTIAL FOR CARCINOGENICITY See full prescribing information for complete boxed warning. Metronidazole has been shown to be carcinogenic in mice and rats ( 5.1 ). Avoid unnecessary use of LIKMEZ. Reserve LIKMEZ for use in the following indications: trichomoniasis ( 1.1 ), amebiasis ( 1.2 ) and anaerobic bacterial infections ( 1.3 ).
LIKMEZ Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to LIKMEZ
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
94 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07451171 | 302580 1R01HD113733-01A1 | Ph 2 | recruiting | Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children |
| NCT07492134 | 251398 1R01DK141523-01A1 | Ph 2 | not yet recruiting | APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis) |
| NCT06569368 | 2023-0880 NCI-2025-07395 | Ph 2 | recruiting | Trial Utilizing Metronidazole to Optimize the Microbiome of Rectal Adenocarcinoma Undergoing Neoadjuvant Therapy |
| NCT01275560 | 2008/073/HP | Ph 3 | completed | Does the Negativation of the Glucose Hydrogen Breath Test Come Along With a Reduction of the Symptoms of Gaz Incontinence ? |
| NCT06131021 PAAS | Pro2023001347 4UH3DE031129-02 | Ph 3 | completed | Shaping the Indications for Periodontal Adjunctive Antibiotics in Dental Practice |
| NCT06627270 | CASE6324 | Ph 2 | recruiting | Antibiotic Treatment Effects on Intratumoral Bacteria Modulation in Surgical Patients With Oral Cancer |
| NCT06616597 | J2485 IRB00453879 | Ph 2 | recruiting | Trial Targeting Gut Bacterial Androgen Production to Reverse Therapeutic Resistance to Abiraterone in Patients With Metastatic Prostate Cancer |
| NCT04729322 | 2020-0186 NCI-2020-13897, 2020-0186 | Ph 2 | active not recruiting | Fecal Microbiota Transplant and Re-introduction of Anti-PD-1 Therapy (Pembrolizumab or Nivolumab) for the Treatment of Metastatic Colorectal Cancer in Anti-PD-1 Non-responders |
| NCT07180615 NeoRiDe | 2025-01074 | Ph 4 | not yet recruiting | Gut Decolonisation With Neomycin/Metronidazole or Rifaximin Before Colon Surgery |
| NCT06806995 | W-5222-106 | Ph 1 | completed | A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination. |
| NCT05874544 | rjhy20230001 | Ph 4 | completed | Rescue Therapy for Helicobacter Pylori Infection |
| NCT04186247 PAZAZ results posted | 19-3100 585718 | Ph 2 | terminated | Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD) |
| NCT06387147 ORIAMI | APHP220818 | Ph 3 | recruiting | ORal Antibiotics in Acute Mesenteric Ischemia |
| NCT06798415 | ALM25-003 apporval no (69) | Ph 2 | recruiting | Intralesional Injection of Metronidazole for the Management of Cutaneous Leishmaniasis |
| NCT06793137 | CEP3589/24 | Ph 2 | recruiting | Intestinal Microbiome Modulation With Antibiotics in the Neoadjuvant Treatment of Locally Advanced Rectal Cancer |
| NCT05874570 | rjhy20230002 | Ph 4 | recruiting | Doxycycline for Helicobacter Pylori Rescue Treatment |
| NCT05784311 SPARROW | NL82304.058.22 | Ph 4 | recruiting | Standard Versus Prolonged Antibiotic Prophylaxis After Pancreatoduodenectomy (SPARROW) |
| NCT05462496 | STUDY-21-01814 | Ph 2 | recruiting | Modulation of the Gut Microbiome With Pembrolizumab Following Chemotherapy in Resectable Pancreatic Cancer |
| NCT06633718 | FL058-301 | Ph 3 | not yet recruiting | Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI |
| NCT06349122 AUTOP2 | 2023-509421-41-00 | Ph 4 | not yet recruiting | Screen-and-treat Strategy for Vaginal Flora Abnormalities in Pregnant Women at High Risk of Preterm Birth |
| NCT04927312 results posted | C3591036 | Ph 3 | completed | Study to Assess Efficacy and Safety of PF-06947386 in Japanese Adult Patients With Complicated Intra-abdominal Infection |
| NCT03187106 PACT | 17-0035 | Ph 1 | completed | Prophylactic Antibiotics After Cesarean |
| NCT05049902 | 2021-SDU-QILU-G001-2 | Ph 4 | completed | Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication |
| NCT04578015 results posted | 2020H0476 | Ph 4 | terminated | A Randomized Controlled Trial of Treatment of Bacterial Vaginosis |
| NCT03557008 results posted | IRB00101567 | Ph 4 | completed | Responses to Rabies Vaccine in Adults With or Without Antibiotics |
| NCT03217136 results posted | 7625A-035 MK-7625A-035, 2016-004820-41 | Ph 2 | completed | MK-7625A Plus Metronidazole Versus Meropenem in Pediatric Participants With Complicated Intra-Abdominal Infection (cIAI) (MK-7625A-035) |
| NCT05720559 | 20230201zzg | Ph 2 | not yet recruiting | Early Blocking Strategy for Metachronous Liver Metastasis of Colorectal Cancer Based on Pre-hepatic CTC Detection |
| NCT03830333 7625ACNPhase3 results posted | 7625A-015 MK-7625A-015 | Ph 3 | completed | Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropenem for Participants With Complicated Intra-abdominal Infection (MK-7625A-015) |
| NCT01426269 results posted | US10183 | Ph 4 | completed | Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo |
| NCT02042287 | 026/13 | Ph 4 | completed | Treatment Comparison of Antibiotics Versus Vaginal Lactic Acid in Non-pregnant Women With Acute Symptomatic Bacterial Vaginosis |
| NCT02969928 results posted | AmxMetClmCFA | Ph 2, Ph 3 | completed | Two Different Antibiotic Agents to Treat Generalized Aggressive Periodontitis |
| NCT05061732 | B2021-376 | Ph 4 | recruiting | Helicobacter Pylori Eradication and Follow-up |
| NCT04024527 | rjyy20190715 | Ph 4 | completed | High Dose of Dual Therapy Plus Metronidazole for Helicobacter Pylori RescueTreatment |
| NCT02606032 FMT | REB# 0163 | Ph 2 | completed | Trial of Antimicrobials Versus Placebo in Addition to Fecal Transplant Therapy in Ulcerative Colitis |
| NCT03794765 AAASUC | NK/5147/DM | Ph 2 | completed | Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis |
| NCT03358576 results posted | IT001-303 | Ph 3 | completed | Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI) |
| NCT02942485 results posted | PGLIT2016 | Ph 4 | terminated | Treatment of Giardia Lamblia Infections in Children |
| NCT02301000 | IMT CDI | Ph 2, Ph 3 | terminated | IMT for Primary Clostridium Difficile Infection |
| NCT01658852 | Gastrectomy-MDZ-001 | Ph 3 | withdrawn | Effects and Safety of Metronidazole in Patients With Gastrectomy |
| NCT03343366 | DUHS/DR-O/2017/266 | Ph 2, Ph 3 | completed | Glycemic Control in T2DM Through Non-Surgical Periodontal Therapy |
| NCT02308007 SMART GIVES results posted | MTC-001 (Trial 3) | Ph 3 | completed | Multi-Center Study of New Medications to Treat Vaginal Infections |
| NCT02308033 SMART GIVES results posted | MTC-001 (Trial 2) | Ph 3 | completed | Multi-Center Study of New Medications to Treat Vaginal Infections |
| NCT04415983 | helicobacter children | Ph 3 | recruiting | Study of Nitazoxanide (NTZ) for Helicobacter Pylori in Children |
| NCT04353362 | Istanbul Medipol | Ph 4 | completed | Alternative Antibiotic Regimen in Periodontitis Treatment |
| NCT02655419 results posted | D4910C00009 C3601001, 2015-002726-39 | Ph 2 | completed | Determine the PK and Safety and Tolerability of ATM-AVI for the Treatment of cIAIs in Hospitalized Adults (REJUVENATE) |
| NCT02766023 results posted | 14-0029 HHSN272201300014I | Ph 2 | completed | LACTIN-V Study for Recurrent Bacterial Vaginosis |
| NCT00667368 results posted | 05-0131 HHSN272201300012I | Ph 3 | completed | Bacterial Vaginosis Home Screening to Prevent STDs |
| NCT03708848 | rjkls2017197 | Ph 4 | completed | Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy |
| NCT02057198 C-Diff results posted | Pro00043361 | Ph 4 | completed | Impact of Oral Antibiotic Treatment on C. Difficile |
| NCT04066257 | CJ_APA_111 | Ph 1 | completed | Evaluate the PK of Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers |
Showing 50 of 94 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LIKMEZ FDA Label Details
Indications & Usage
FDA Label (PDF)LIKMEZ is indicated for the treatment of Trichomoniasis; Amebiasis; Anaerobic Bacterial Infections; Intra-abdominal Infections; Peritonitis; Intra-abdominal Abscess; Liver Abscess.
WARNING: POTENTIAL FOR CARCINOGENICITY Metronidazole has been shown to be carcinogenic in mice and rats [ see Warnings and Precautions (5.1) ] . Avoid unnecessary use of LIKMEZ. Reserve LIKMEZ for use in the following indications: trichomoniasis [see Indications and Usage (1.1) ] , amebiasis [ see I...
LIKMEZ Patents & Exclusivity
Patents (2 active)
Pro Intelligence Preview
Deep insights for LIKMEZ
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 4 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.