Data updated: May 26, 2026
METROCREAM (metronidazole)
Dermatology
Approved 1995-09-20
METROCREAM is indicated for the treatment of Rosacea.
Source: FDA Label • GALDERMA LABS LP
1
Indication
--
Phase 3 Trials
30
Years on Market
Details
- Status
- Prescription
- First Approved
- 1995-09-20
- Routes
- TOPICAL
- Dosage Forms
- CREAM
METROCREAM Approval History
1996
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2002
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2012
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Original
New Indication
New Form
Label Update
2 FDA actions from 1995 to 2002
Aug 2002 SUPPL
Mfg · Manufacturing (CMC)
Sep 1995 ORIGINAL
New Form · Type 3 - New Dosage Form
What METROCREAM Treats
1 indicationsMETROCREAM is approved for 1 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rosacea
Source: FDA Label
METROCREAM Competitive Set
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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
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Trial Timeline
Full development history with FDA approval milestones
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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.
METROCREAM FDA Label Details
Indications & Usage
METROCREAM is indicated for the treatment of Rosacea.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.