Overview
Methimazole is a thionamide antithyroid agent that inhibits the synthesis of thyroid hormones. It was first introduced as an antithyroid agent in 1949 and is now commonly used in the management of hyperthyroidism, particularly in those for whom more aggressive options such as surgery or radioactive iodine therapy are inappropriate. On a weight basis, methimazole is 10 times more potent than the other major antithyroid thionamide used in North America, propylthiouracil, and is the active metabolite of the pro-drug carbimazole, which is an antithyroid medication used in the United Kingdom and parts of the former British Commonwealth. Traditionally, methimazole has been preferentially used over propylthiouracil due to the risk of fulminant hepatotoxicity carried by the latter, with propylthiouracil being preferred in pregnancy due to a perceived lower risk of teratogenic effects. Despite documented teratogenic effects in its published labels, the true teratogenicity of methimazole appears to be unclear and its place in therapy may change in the future.
Indication
In the United States, methimazole is indicated for the treatment of hyperthyroidism in patients with Graves' disease or toxic multinodular goiter for whom thyroidectomy or radioactive iodine therapy are not appropriate treatment options. Methimazole is also indicated for the amelioration of hyperthyroid symptoms in preparation for thyroidectomy or radioactive iodine therapy. In Canada, methimazole carries the above indications and is also indicated for the medical treatment of hyperthyroidism regardless of other available treatment options.
Associated Conditions
- Graves' Disease
- Hyperthyroidism
- Toxic multinodular goiter
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2023/07/28 | N/A | Terminated | Cook County Health | ||
2022/11/07 | Phase 2 | Recruiting | |||
2022/07/18 | Phase 4 | Recruiting | |||
2021/11/12 | Phase 3 | Completed | |||
2021/08/24 | Early Phase 1 | Withdrawn | |||
2021/03/02 | Phase 3 | Recruiting | |||
2020/04/15 | Phase 1 | Completed | Dr.dr.Irma Bernadette, SpKK (K) | ||
2018/02/27 | N/A | UNKNOWN | First Affiliated Hospital of Harbin Medical University | ||
2018/02/14 | N/A | UNKNOWN | First Affiliated Hospital of Harbin Medical University | ||
2018/01/04 | N/A | UNKNOWN | First Affiliated Hospital of Harbin Medical University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Preferred Pharmaceuticals Inc. | 68788-8226 | ORAL | 5 mg in 1 1 | 8/2/2023 | |
American Health Packaging | 60687-680 | ORAL | 10 mg in 1 1 | 2/7/2023 | |
Bryant Ranch Prepack | 71335-0883 | ORAL | 10 mg in 1 1 | 3/24/2022 | |
Bryant Ranch Prepack | 63629-9251 | ORAL | 10 mg in 1 1 | 2/28/2022 | |
Par Pharmaceutical, Inc. | 49884-641 | ORAL | 10 mg in 1 1 | 5/3/2022 | |
Bryant Ranch Prepack | 63629-2224 | ORAL | 10 mg in 1 1 | 8/11/2023 | |
State of Florida DOH Central Pharmacy | 53808-0850 | ORAL | 10 mg in 1 1 | 9/25/2013 | |
Chartwell RX, LLC | 62135-205 | ORAL | 5 mg in 1 1 | 12/12/2022 | |
Bryant Ranch Prepack | 63629-9250 | ORAL | 5 mg in 1 1 | 2/28/2022 | |
Rebel Distributors Corp. | 42254-009 | ORAL | 10 mg in 1 1 | 7/6/2010 |
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 |
---|---|---|---|---|---|
THYROZOL TABLET 5 mg | SIN09589P | TABLET, FILM COATED | 5 mg | 12/22/1997 | |
THYROZOL TABLET 10 mg | SIN09588P | TABLET, FILM COATED | 10 mg | 12/22/1997 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
LICA TAB 5MG | N/A | N/A | N/A | 4/28/1982 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
JAMP METHIMAZOLE | 02490633 | Tablet - Oral | 10 MG | 8/21/2021 | |
METHIMAZOLE TABLETS USP | Endo Operations Ltd. | 02489716 | Tablet - Oral | 5 MG | N/A |
APO-METHIMAZOLE | 02258935 | Tablet - Oral | 5 MG | 3/18/2005 | |
MAR-METHIMAZOLE | marcan pharmaceuticals inc | 02480107 | Tablet - Oral | 5 MG | 10/19/2018 |
DOM-METHIMAZOLE | dominion pharmacal | 02265869 | Tablet - Oral | 5 MG | N/A |
PHL-METHIMAZOLE | pharmel inc | 02265850 | Tablet - Oral | 5 MG | N/A |
TAPAZOLE | Endo Operations Ltd. | 00015741 | Tablet - Oral | 5 MG | 12/31/1951 |
METHIMAZOLE TABLETS USP | Endo Operations Ltd. | 02489732 | Tablet - Oral | 20 MG | N/A |
JAMP METHIMAZOLE | 02490625 | Tablet - Oral | 5 MG | 8/21/2020 | |
MAR-METHIMAZOLE | marcan pharmaceuticals inc | 02480115 | Tablet - Oral | 10 MG | 10/19/2018 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
TIRODRIL 5mg COMPRIMIDOS | Laboratorio Estedi S.L. | 24700 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
TIRODRIL 10 MG COMPRIMIDOS | Laboratorio Estedi S.L. | 84928 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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