Pyrimethamine

Overview

One of the folic acid antagonists that is used as an antimalarial or with a sulfonamide to treat toxoplasmosis.

Indication

For the treatment of toxoplasmosis and acute malaria; For the prevention of malaria in areas non-resistant to pyrimethamine

Associated Conditions

Toxoplasmosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Optimizing Reversal of HIV Latency With Combination Therapy	2024/02/05	NCT06240520	Phase 1	Not yet recruiting	Erasmus Medical Center
CD40 Agonist and PD-1 Inhibitor in HNSCC	2023/12/07	NCT06159621	Phase 1	Recruiting	University of Pennsylvania
Pyrimethamine as an Inhibitor of NRF2 in HPV-unrelated Locally Advanced Head and Neck Squamous Cell Carcinoma	2023/01/10	NCT05678348	Early Phase 1	Active, not recruiting	Washington University School of Medicine
Bioequivalence Study of Sulfadoxine/ Pyrimethamine Dispersible Tablets in Healthy Subjects Under Fasting Conditions	2022/08/11	NCT05497063	Phase 1	UNKNOWN	Emzor Pharmaceutical Industries Limited
Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product	2022/03/16	NCT05282940	Phase 1	Completed	Laboratorios Andromaco S.A.
CAR-T for Children With Relapsed and Refractory Acute Lymphoblastic Leukemia	2020/11/13	NCT04626765	Early Phase 1	UNKNOWN	Hebei Senlang Biotechnology Inc., Ltd.
An Investigational Study to Determine the Drug Level Profile of BMS-986165 in Healthy Male Volunteers Following Transporter Inhibition.	2019/09/12	NCT04086719	Phase 1	Completed	Bristol-Myers Squibb
Sanaria PfSPZ Challenge With Pyrimethamine or Chloroquine Chemoprophylaxis Vaccination (PfSPZ-CVac Approach): A Randomized Double Blind Placebo Controlled Phase I/II Trial to Determine Safety and Protective Efficacy Against Natural Plasmodium Falcipa...	2019/05/16	NCT03952650	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)
LRAs United as a Novel Anti-HIV Strategy.	2018/05/16	NCT03525730	Phase 1	Completed	Erasmus Medical Center
Phase I Study of Pyrimethamine in Healthy Japanese and Caucasian Subjects	2017/08/23	NCT03258762	Phase 1	Completed	GlaxoSmithKline

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Pyrimethamine Leucovorin	South Coast Specialty Compounding, Inc. d/b/a Park Compounding	70260-430	ORAL	12.5 mg in 1 1	11/25/2015
Daraprim	TILDE Sciences LLC	83649-330	ORAL	25 mg in 1 1	12/7/2023
Daraprim	Vyera Pharmaceuticals LLC	69413-330	ORAL	25 mg in 1 1	11/24/2021
Pyrimethamine Leucovorin	South Coast Specialty Compounding, Inc. d/b/a Park Compounding	70260-426	ORAL	25 mg in 1 1	11/25/2015
Pyrimethamine Leucovorin	ImprimisRx PA, Inc. d/b/a ImprimisRx	70271-429	ORAL	50 mg in 1 1	11/27/2015
Pyrimethamine Leucovorin	ImprimisRx PA, Inc. d/b/a ImprimisRx	70271-480	ORAL	50 mg in 1 1	11/27/2015
Pyrimethamine	OAKRUM PHARMA, LLC	72647-330	ORAL	25 mg in 1 1	3/18/2020
Pyrimethamine	DR.REDDYS LABORATORIES INC	43598-672	ORAL	25 mg in 1 1	3/20/2023
Pyrimethamine Leucovorin	ImprimisRx PA, Inc. d/b/a ImprimisRx	70271-428	ORAL	50 mg in 1 1	11/27/2015
Pyrimethamine Leucovorin	ImprimisRx PA, Inc. d/b/a ImprimisRx	70271-426	ORAL	25 mg in 1 1	11/27/2015

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
No HSA approvals found for this drug.

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
Daraprim Tablets	97531	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/11/2003
Daraprim Tablets	97456	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/11/2003

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
DARAPRIM	amedra pharmaceuticals llc	00004774	Tablet - Oral	25 MG	12/31/1952
FANSIDAR TABLETS	Hoffmann-La Roche Limited	00692719	Tablet - Oral	25 MG	12/31/1989

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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