MedPath

Primaquine

Generic Name
Primaquine
Drug Type
Small Molecule
Chemical Formula
C15H21N3O
CAS Number
90-34-6
Unique Ingredient Identifier
MVR3634GX1

Overview

An aminoquinoline that is given by mouth to produce a radical cure and prevent relapse of vivax and ovale malarias following treatment with a blood schizontocide. It has also been used to prevent transmission of falciparum malaria by those returning to areas where there is a potential for re-introduction of malaria. Adverse effects include anemias and GI disturbances. (From Martindale, The Extra Pharmacopeia, 30th ed, p404)

Indication

For the treatment of malaria.

Associated Conditions

  • Malaria
  • Malaria caused by Plasmodium ovale
  • Malaria caused by plasmodium vivax
  • Pneumocystis Jirovecii Pneumonia

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2024/10/30
Phase 3
Recruiting
2024/03/06
Phase 1
Completed
2024/01/05
Phase 4
Completed
2023/11/28
Phase 3
Recruiting
2023/09/21
Phase 4
Completed
Dinka Dugassa
2023/09/13
Phase 2
Completed
Syamsudin Abdillah,Ph.D, Pharm D
2023/07/25
N/A
Completed
Research Institute for Tropical Medicine, Philippines
2023/07/25
N/A
Completed
Research Institute for Tropical Medicine, Philippines
2023/07/24
N/A
Completed
Research Institute for Tropical Medicine, Philippines
2023/04/25
Phase 2
Completed
Syamsudin Abdillah,Ph.D, Pharm D

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
AvKARE
42291-510
ORAL
15 mg in 1 1
1/9/2024
Bayshore Pharmaceuticals, LLC
76385-102
ORAL
15 mg in 1 1
1/17/2020
Ingenus Pharmaceuticals, LLC
50742-191
ORAL
15 mg in 1 1
1/31/2018
Aidarex Pharmaceuticals LLC
33261-671
ORAL
15 mg in 1 1
9/8/2017
PD-Rx Pharmaceuticals, Inc.
43063-721
ORAL
15 mg in 1 1
5/19/2023
Sanofi-Aventis U.S. LLC
0024-1596
ORAL
15 mg in 1 1
8/21/2019

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
Primaquine Phosphate Tablets
国药准字H51021839
化学药品
片剂(糖衣)
12/18/2020
Primaquine Phosphate Tablets
国药准字H31020472
化学药品
片剂(糖衣)
9/18/2020
Primaquine Phosphate Tablets
国药准字H20059843
化学药品
片剂(糖衣)
3/13/2020
Primaquine Phosphate Tablets
国药准字H50020205
化学药品
片剂
8/17/2020
Primaquine Phosphate Tablets
国药准字H37020309
化学药品
片剂
3/1/2020
Primaquine Phosphate Tablets
国药准字H50020542
化学药品
片剂
9/23/2020

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
PRIMACIN primaquine (as phosphate) 7.5mg tablet bottle
226430
Medicine
A
11/10/2014

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