Overview
Levothyroxine is a synthetically produced form of thyroxine, a major endogenous hormone secreted by the thyroid gland. Also known as L-thyroxine or the brand name product Synthroid, levothyroxine is used primarily to treat hypothyroidism, a condition where the thyroid gland is no longer able to produce sufficient quantities of the thyroid hormones T (tetraiodothyronine or thyroxine) and T (triiodothyronine or Liothyronine), resulting in diminished down-stream effects of these hormones. Without sufficient quantities of circulating thyroid hormones, symptoms of hypothyroidism begin to develop such as fatigue, increased heart rate, depression, dry skin and hair, muscle cramps, constipation, weight gain, memory impairment, and poor tolerance to cold temperatures. In response to Thyroid Stimulating Hormone (TSH) release by the pituitary gland, a normally functioning thyroid gland will produce and secrete T, which is then converted through deiodination (by type I or type II 5′-deiodinases) into its active metabolite T. While T is the major product secreted by the thyroid gland, T exerts the majority of the physiological effects of the thyroid hormones; T and T have a relative potency of ~1:4 (T4:T3). T and T act on nearly every cell of the body, but have a particularly strong effect on the cardiac system. As a result, many cardiac functions including heart rate, cardiac output, and systemic vascular resistance are closely linked to thyroid status. Prior to the development of levothyroxine, Thyroid, porcine or desiccated thyroid, used to be the mainstay of treatment for hypothyroidism. However, this is no longer recommended for the majority of patients due to several clinical concerns including limited controlled trials supporting its use. Desiccated thyroid products contain a ratio of T4 to T3 of 4.2:1, which is significantly lower than the 14:1 ratio of secretion by the human thyroid gland. This higher proportion of T3 in desiccated thyroid products can lead to supraphysiologic levels of T3 which may put patients at risk of thyrotoxicosis if thyroid extract therapy is not adjusted according to the serum TSH.
Background
Levothyroxine is a synthetically produced form of thyroxine, a major endogenous hormone secreted by the thyroid gland. Also known as L-thyroxine or the brand name product Synthroid, levothyroxine is used primarily to treat hypothyroidism, a condition where the thyroid gland is no longer able to produce sufficient quantities of the thyroid hormones T (tetraiodothyronine or thyroxine) and T (triiodothyronine or Liothyronine), resulting in diminished down-stream effects of these hormones. Without sufficient quantities of circulating thyroid hormones, symptoms of hypothyroidism begin to develop such as fatigue, increased heart rate, depression, dry skin and hair, muscle cramps, constipation, weight gain, memory impairment, and poor tolerance to cold temperatures. In response to Thyroid Stimulating Hormone (TSH) release by the pituitary gland, a normally functioning thyroid gland will produce and secrete T, which is then converted through deiodination (by type I or type II 5′-deiodinases) into its active metabolite T. While T is the major product secreted by the thyroid gland, T exerts the majority of the physiological effects of the thyroid hormones; T and T have a relative potency of ~1:4 (T4:T3). T and T act on nearly every cell of the body, but have a particularly strong effect on the cardiac system. As a result, many cardiac functions including heart rate, cardiac output, and systemic vascular resistance are closely linked to thyroid status. Prior to the development of levothyroxine, Thyroid, porcine or desiccated thyroid, used to be the mainstay of treatment for hypothyroidism. However, this is no longer recommended for the majority of patients due to several clinical concerns including limited controlled trials supporting its use. Desiccated thyroid products contain a ratio of T4 to T3 of 4.2:1, which is significantly lower than the 14:1 ratio of secretion by the human thyroid gland. This higher proportion of T3 in desiccated thyroid products can lead to supraphysiologic levels of T3 which may put patients at risk of thyrotoxicosis if thyroid extract therapy is not adjusted according to the serum TSH.
Indication
Levothyroxine is indicated as replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism. It is also indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
Associated Conditions
- Edematous Fibrosclerotic Panniculopathy (Cellulite)
- Hypothyroidism
- Localized Adiposity
- Myxedema coma
- Euthyroid Goitre
- Thyrotropin dependent Well-Differentiated Thyroid Cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/05/31 | Phase 3 | Not yet recruiting | |||
2025/05/14 | Not Applicable | Not yet recruiting | |||
2024/12/12 | Phase 2 | Recruiting | UConn Health | ||
2024/10/28 | Phase 3 | Recruiting | |||
2024/10/22 | Not Applicable | Not yet recruiting | |||
2024/10/22 | Phase 4 | Not yet recruiting | Yang ZHANG | ||
2024/10/18 | N/A | Not yet recruiting | |||
2024/10/03 | Phase 1 | Completed | |||
2024/08/09 | Phase 1 | Completed | Berlin-Chemie AG Menarini Group | ||
2024/07/30 | N/A | Terminated | Third Affiliated Hospital of Zhengzhou University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Northwind Pharmaceuticals | 51655-696 | ORAL | 0.125 mg in 1 1 | 3/27/2023 | |
Pfizer Laboratories Div Pfizer Inc | 60793-854 | ORAL | 100 ug in 1 1 | 12/15/2020 | |
Teva Pharmaceuticals, Inc. | 0480-8715 | ORAL | 150 ug in 1 1 | 9/22/2022 | |
Northwind Pharmaceuticals | 51655-295 | ORAL | 0.1 mg in 1 1 | 1/23/2015 | |
Northwind Pharmaceuticals | 51655-124 | ORAL | 57 ug in 1 1 | 1/26/2015 | |
NuCare Pharmaceuticals,Inc. | 68071-4625 | ORAL | 75 ug in 1 1 | 4/24/2019 | |
Lupin Pharmaceuticals, Inc. | 68180-973 | ORAL | 0.15 mg in 1 1 | 3/14/2024 | |
NuCare Pharmaceuticals,Inc. | 68071-4735 | ORAL | 0.15 mg in 1 1 | 5/1/2019 | |
Acella Pharmaceuticals, LLC | 42192-328 | ORAL | 76 ug in 1 1 | 4/25/2023 | |
Camber Pharmaceuticals, Inc. | 31722-284 | ORAL | 0.025 mg in 1 1 | 1/23/2023 |
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 |
---|---|---|---|---|---|
LEVOTHYROXINE SODIUM FOR INJECTION 500 mcg/vial | SIN09760P | INJECTION, POWDER, FOR SOLUTION | 500 mcg/vial | 5/19/1998 | |
THYROCORD 50 TABLET 50 MCG | SIN16696P | TABLET | 0.05 mg | 2/15/2023 | |
EUTHYROX TABLET 50 mcg | SIN09740P | TABLET | 50 mcg | 5/6/1998 | |
ROVEXINE-75 TABLETS 75MCG | SIN16627P | TABLET | 75 mcg | 10/10/2022 | |
EUTHYROX TABLET 25 mcg | SIN09739P | TABLET | 25 mcg | 5/6/1998 | |
ROVEXINE-50 TABLETS 50MCG | SIN16628P | TABLET | 50 mcg | 10/10/2022 | |
EUTHYROX TABLET 100 mcg | SIN09741P | TABLET | 100 mcg | 5/6/1998 | |
ROVEXINE-25 TABLETS 25MCG | SIN16629P | TABLET | 25 mcg | 10/10/2022 | |
THYROCORD 75 TABLET 75 MCG | SIN16695P | TABLET | 0.075 mg | 2/15/2023 | |
THYROCORD 100 TABLET 100 MCG | SIN16694P | TABLET | 0.1 mg | 2/15/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Levothyroxine Sodium Tablets | 国药准字HJ20240127 | 化学药品 | 片剂 | 11/5/2024 | |
Levothyroxine Sodium Tablets | 国药准字H20041605 | 化学药品 | 片剂 | 3/22/2024 | |
Levothyroxine Sodium Tablets | 国药准字HJ20255001 | 化学药品 | 片剂 | 1/13/2025 | |
Levothyroxine Sodium Tablets | 国药准字H20227080 | 化学药品 | 片剂 | 6/13/2022 | |
Levothyroxine Sodium Tablets | 国药准字HJ20160236 | 化学药品 | 片剂 | 12/1/2020 | |
Levothyroxine Sodium Tablets | 国药准字H20227081 | 化学药品 | 片剂 | 6/13/2022 | |
Levothyroxine Sodium Tablets | 国药准字H20010522 | 化学药品 | 片剂 | 6/10/2020 | |
Levothyroxine Sodium Tablets | 国药准字HJ20240128 | 化学药品 | 片剂 | 11/5/2024 | |
Levothyroxine Sodium Tablets | 国药准字HJ20140051 | 化学药品 | 片剂 | 2/6/2024 | |
Levothyroxine Sodium Tablets | 国药准字HJ20140052 | 化学药品 | 片剂 | 2/6/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
LEVOTHYROXINE TAB 100MCG | N/A | teva pharmaceutical hong kong o/b teva pharmaceutical hong kong limited | N/A | N/A | 10/24/2011 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
ELTROXIN levothyroxine sodium 100 microgram tablet bottle | 206963 | Medicine | A | 5/19/2014 | |
LEVOTHOX levothyroxine sodium 88 microgram tablet blister | 363951 | Medicine | A | 7/25/2022 | |
LEVOTHOX levothyroxine sodium 25 microgram tablet blister | 363999 | Medicine | A | 7/25/2022 | |
THOXINE levothyroxine sodium 75 microgram tablet blister | 364020 | Medicine | A | 7/25/2022 | |
THOXINE levothyroxine sodium 100 microgram tablet bottle | 364021 | Medicine | A | 7/25/2022 | |
THOXINE levothyroxine sodium 137 microgram tablet bottle | 363993 | Medicine | A | 7/25/2022 | |
ELTROXIN levothyroxine sodium 200 microgram tablet bottle | 206954 | Medicine | A | 5/19/2014 | |
LEVOTHYROXINE SANDOZ levothyroxine sodium 200 microgram tablet blister pack | 387275 | Medicine | A | 3/21/2023 | |
LEVOTHYROXINE SANDOZ levothyroxine sodium 100 microgram tablet blister pack | 387276 | Medicine | A | 3/21/2023 | |
LEVOTHYROXINE LUP levothyroxine sodium 125 microgram un-coated tablet blister pack | 374930 | Medicine | A | 12/23/2022 |