Overview
Methenamine is a heterocyclic organic compound with a cage-like structure similar to adamantane. In salt form it is used for the treatment of urinary tract infection (Example: methenamine hippurate which is the hippuric acid salt of methenamine).
Background
Methenamine is a heterocyclic organic compound with a cage-like structure similar to adamantane. In salt form it is used for the treatment of urinary tract infection (Example: methenamine hippurate which is the hippuric acid salt of methenamine).
Indication
For prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. This drug is not used to treat infection and should only be used after appropriate eradication of infection with antimicrobial agents.
Associated Conditions
- Urinary Tract Infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/01 | Phase 4 | Not yet recruiting | Women and Infants Hospital of Rhode Island | ||
2025/02/05 | Not Applicable | Recruiting | |||
2024/11/29 | Early Phase 1 | Not yet recruiting | |||
2022/12/21 | Phase 3 | Active, not recruiting | Jocelyn Fitzgerald | ||
2021/01/14 | Phase 4 | Terminated | |||
2019/09/04 | Phase 4 | Completed | |||
2019/06/24 | Phase 4 | Withdrawn | |||
2019/01/28 | Phase 2 | Completed | |||
2017/12/20 | Phase 4 | Completed | |||
2017/03/13 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aurobindo Pharma Limited | 65862-782 | ORAL | 1 g in 1 1 | 1/23/2024 | |
| Meda Pharmaceuticals | 0037-6321 | ORAL | 81 mg in 1 1 | 1/13/2015 | |
| Star Pharmaceuticals, LLC | 0076-0111 | ORAL | 120 mg in 1 1 | 1/24/2017 | |
| Micro Labs Limited | 42571-332 | ORAL | 1000 mg in 1 1 | 11/25/2021 | |
| A.G. Marin Pharmaceutical | 12539-144 | ORAL | 81.6 mg in 1 1 | 10/7/2022 | |
| Carilion Materials Management | 68151-0984 | ORAL | 1 g in 1 1 | 6/18/2014 | |
| Edenbridge Pharmaceuticals LLC. | 42799-105 | ORAL | 500 mg in 1 1 | 11/10/2021 | |
| Star Pharmaceuticals LLC | 0076-0903 | ORAL | 120 mg in 1 1 | 1/10/2017 | |
| Mission Pharmacal Company | 0178-0745 | ORAL | 81.6 mg in 1 1 | 1/22/2024 | |
| Vilvet Pharmaceuticals Inc | 71186-000 | ORAL | 81 mg in 1 1 | 2/21/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Methenamine Solution | 国药准字H20073721 | 化学药品 | 喷雾剂 | 4/26/2023 | |
| Methenamine Solution | 国药准字H20043851 | 化学药品 | 溶液剂 | 7/13/2020 | |
| Methenamine Solution | 国药准字H45021084 | 化学药品 | 溶液剂 | 8/8/2020 | |
| Methenamine Solution | 国药准字H20103051 | 化学药品 | 溶液剂 | 7/11/2024 | |
| Methenamine Solution | 国药准字H41024617 | 化学药品 | 溶液剂(外用) | 3/27/2020 | |
| Urotropine Tablets | 国药准字H11022328 | 化学药品 | 片剂 | 9/1/2020 | |
| Urotropine Tablets | 国药准字H53021750 | 化学药品 | 片剂 | 7/6/2020 | |
| Urotropine Tablets | 国药准字H41024891 | 化学药品 | 片剂 | 1/9/2020 | |
| Urotropine Tablets | 国药准字H50021896 | 化学药品 | 片剂 | 8/27/2020 | |
| Urotropine Tablets | 国药准字H61022722 | 化学药品 | 片剂 | 8/18/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| APOHEALTH URINARY TRACT ANTIBACTERIAL methenamine hippurate 1 g tablet bottle | 380193 | Medicine | A | 12/3/2021 | |
| HIPREX methenamine hippurate 1g tablet - uncoated bottle | 10558 | Medicine | A | 7/4/1991 | |
| HEXAMINE B&B methenamine hippurate 1 g tablet blister pack | 380186 | Medicine | A | 12/3/2021 | |
| HEXAMINE MICRO methenamine hippurate 1 g tablet blister pack | 380188 | Medicine | A | 12/3/2021 | |
| URAMET methenamine hippurate 1 g tablet bottle | 339589 | Medicine | A | 7/15/2020 | |
| HEXAMINE B&B methenamine hippurate 1 g tablet bottle | 380187 | Medicine | A | 12/3/2021 | |
| MICROHEXA methenamine hippurate 1 g tablet blister pack | 380190 | Medicine | A | 12/3/2021 | |
| UTIBAC methenamine hippurate 1 g tablet bottle | 457628 | Medicine | A | 7/30/2024 | |
| APOHEALTH URINARY TRACT ANTIBACTERIAL methenamine hippurate 1 g tablet blister pack | 380192 | Medicine | A | 12/3/2021 | |
| HEXAMINE MICRO methenamine hippurate 1 g tablet bottle | 380189 | Medicine | A | 12/3/2021 |