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Levothyroxine

Generic Name
Levothyroxine
Brand Names
Eltroxin, Ermeza, Euthyrox, Levo-T, Levothroid, Levoxyl, Np Thyroid, Synthroid, Thyquidity, Tirosint, Unithroid
Drug Type
Small Molecule
Chemical Formula
C15H11I4NO4
CAS Number
51-48-9
Unique Ingredient Identifier
Q51BO43MG4

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
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