Propylthiouracil

Overview

A thiourea antithyroid agent. Propythiouracil inhibits the synthesis of thyroxine and inhibits the peripheral conversion of throxine to tri-iodothyronine. It is used in the treatment of hyperthyroidism. (From Martindale, The Extra Pharmacopeoia, 30th ed, p534)

Indication

Used to manage hyperthyroidism which is due to an overactive thyroid gland (Grave's disease).

Associated Conditions

Hyperthyroidism
Thyrotoxic crisis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Networked Drug REpurposing for Mechanism-based neuroPrOtection in Acute Ischaemic STROKE	2023/03/09	NCT05762146	Phase 2	Recruiting	Maastricht University
Effect of Hyperthyroidism and Its Treatment in Graves' Disease to Early Marker of Atherosclerosis	2021/11/12	NCT05118542	Phase 3	Completed	Indonesia University
The Oral Microbiota is Associated With Autoimmune Thyroiditis	2018/02/27	NCT03447093	N/A	UNKNOWN	First Affiliated Hospital of Harbin Medical University
Intestinal Microbiota and Treatment of GD	2018/02/14	NCT03433352	N/A	UNKNOWN	First Affiliated Hospital of Harbin Medical University
Antithyroid Drug Treatment of Thyrotoxicosis in Young People	2011/09/20	NCT01436994	Phase 3	Completed	Newcastle-upon-Tyne Hospitals NHS Trust
The Effect of Early Total Thyroidectomy in the Course of Graves' Orbitopathy	2010/01/26	NCT01056419	Phase 4	UNKNOWN	Ankara University
Thyroid Disease in Pregnancy: Case Finding Versus Universal Screening	2009/02/19	NCT00846755	Not Applicable	Completed	Ospedale V. Fazzi

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
PROPYLTHIOURACIL	QUAGEN PHARMACEUTICALS LLC	70752-171	ORAL	50 mg in 1 1	2/15/2023
PROPYLTHIOURACIL	Bryant Ranch Prepack	72162-2072	ORAL	50 mg in 1 1	8/15/2023
Propylthiouracil	Macleods Pharmaceuticals Limited	33342-314	ORAL	50 mg in 1 1	5/18/2023
Propylthiouracil	Actavis Pharma, Inc.	0228-2348	ORAL	50 mg in 1 1	10/31/2021
Propylthiouracil	Rebel Distributors Corp.	42254-010	ORAL	50 mg in 1 1	8/25/2011
Propylthiouracil	American Health Packaging	68084-964	ORAL	50 mg in 1 1	10/4/2022
Propylthiouracil	Chartwell RX, LLC	62135-606	ORAL	50 mg in 1 1	12/26/2023

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
PROPYL TABLET 50 mg	SRIPRASIT PHARMA CO LTD	SIN11695P	TABLET	50 mg	10/8/2001
PROPYLTHIOURACIL TABLETS BP 50 mg	PT ACTAVIS INDONESIA	SIN00772P	TABLET	50 mg	5/4/1988
PROPYLTHIOURACIL TABLET BP 50 mg	RECIPHARM LIMITED	SIN04664P	TABLET	50 mg	6/14/1990

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
PTU propylthiouracil 50mg tablet bottle	13319	Phebra Pty Ltd	Medicine	A	8/28/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
PMS-PROPYLTHIOURACIL	Pharmascience Inc	02245833	Tablet - Oral	50 MG	N/A
PMS-PROPYLTHIOURACIL	Pharmascience Inc	02245834	Tablet - Oral	100 MG	N/A
APO-PROPYLTHIOURACIL	Apotex Inc	02357941	Tablet - Oral	100 MG	N/A
APO-PROPYLTHIOURACIL	Apotex Inc	02357933	Tablet - Oral	50 MG	N/A
HALYCIL	halewood chemicals limited	02521059	Tablet - Oral	50 MG	3/23/2022
PROPYL-THYRACIL	paladin pharma inc.	00010219	Tablet - Oral	100 MG	12/31/1945
PROPYLTHIOURACIL TABLETS	phebra canada inc	02523019	Tablet - Oral	50 MG	7/21/2022
PROPYL-THYRACIL	paladin pharma inc.	00010200	Tablet - Oral	50 MG	12/31/1951

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.

AI-Powered Research

Premium Access