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Thyrotropin alfa

Generic Name
Thyrotropin alfa
Brand Names
Thyrogen
Drug Type
Biotech
CAS Number
194100-83-9
Unique Ingredient Identifier
AVX3D5A4LM

Overview

Thyrotropin alfa is a recombinant form of thyroid stimulating hormone used in performing certain tests in patients who have or have had thyroid cancer. It is also used along with a radioactive agent to destroy remaining thyroid tissue in certain patients who have had their thyroid gland removed because of thyroid cancer. It is a heterodimeric glycoprotein comprised of two non-covalently linked subunits, an alpha subunit of 92 amino acid residues containing two N-linked glycosylation sites and a beta subunit of 112 residues containing one N-linked glycosylation site. The alpha subunit of thyrotropin alfa, which is the effector region responsible for the stimulation of adenylate cyclase, displays close structural similarity with the alpha subunit of human chorionic gonadotropin (hCG), luteinizing hormone (LH), and follicle-stimulating hormone (FSH). The beta subunit (TSHB) bestows its receptor specificity due to the uniqueness to TSH. The amino acid sequence of thyrotropin alfa is identical to that of human pituitary thyroid stimulating hormone.

Indication

For detection of residueal or recurrent thyroid cancer

Associated Conditions

  • Thyroid Cancer

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/06/04
Phase 2
Recruiting
City of Hope Medical Center
2024/05/28
Not Applicable
Recruiting
2024/05/08
Not Applicable
Recruiting
2022/12/30
Phase 2
Recruiting
2019/02/15
Phase 2
Recruiting
2017/08/10
Phase 2
UNKNOWN
2014/10/29
Phase 1
Completed
2014/05/22
Early Phase 1
Completed
2013/04/23
Phase 3
Active, not recruiting
2012/11/29
N/A
Completed
Genzyme, a Sanofi Company

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Genzyme Corporation
58468-0030
INTRAMUSCULAR
0.9 mg in 1 mL
2/24/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
Authorised
3/9/2000

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
Thyrogen 0.9 mg Powder for Solution for Injection
SIN13164P
INJECTION, POWDER, FOR SOLUTION
1.1 mg
12/27/2005

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
THYROGEN thyrotropin alfa-rch 0.9 mg powder for injection vial
79777
Medicine
A
8/14/2001

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
THYROGEN
sanofi-aventis canada inc
02246016
Powder For Solution - Intramuscular
0.9 MG / VIAL
8/12/2002

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

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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