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Data updated: May 26, 2026

KRINTAFEL (tafenoquine succinate)

Orphan Drug Breakthrough Therapy Priority Review
Infectious Disease Approved 2018-07-20

Krintafel helps patients aged 16 and older prevent the relapse of Plasmodium vivax malaria. It is used in combination with chloroquine therapy during an active infection to ensure the parasite does not return. This medication provides a radical cure but is not used to manage the initial, acute symptoms of the disease.

Source: FDA Label • GSK
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How KRINTAFEL Works

Krintafel works as an 8-aminoquinoline antimalarial drug. It targets the Plasmodium vivax parasite to prevent the infection from recurring in the future.

Source: FDA Label
1
Indication
--
Phase 3 Trials
1
Priority Reviews
7
Years on Market

Details

Status
Prescription
First Approved
2018-07-20
Routes
ORAL
Dosage Forms
TABLET

Companies

GSK
Active Ingredient: TAFENOQUINE SUCCINATE

KRINTAFEL Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2018 to 2020
Nov 2020 SUPPL
Label · Labeling
FDA Letter Label
Jul 2018 ORIGINAL Priority
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What KRINTAFEL Treats

1 indications

KRINTAFEL is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Malaria
Source: FDA Label

KRINTAFEL Competitive Set

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Indication competitors

6

Same indication, different mechanism — what else might this patient receive?

SOVUNA
NOVITIUM PHARMA
2022 4 indic.
QUININE SULFATE
NOVAST LABS
2012 1 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to KRINTAFEL

3 of 7

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ARAKODA
TAFENOQUINE SUCCINATE
1 shared
60 DEGREES PHARMS
Shared indications:
Malaria
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
ATOVAQUONE
1 shared
GLENMARK PHARMS LTD
Shared indications:
Malaria
COARTEM
ARTEMETHER
1 shared
Novartis
Shared indications:
Malaria
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Active Pipeline

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Key Completed Trials

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Trial Timeline

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Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

KRINTAFEL FDA Label Details

Indications & Usage

FDA Label (PDF)

KRINTAFEL is indicated for the treatment of Malaria.

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Data Sources

FDA Approval: NDA210795 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.