Last reviewed 2026-06-01 · How we verify

PQ (0.75)

London School of Hygiene and Tropical Medicine · Phase 3 active Small molecule ✓ Verified Jun 2026

PQ (0.75) is a 8-aminoquinoline antimalarial Small molecule drug developed by London School of Hygiene and Tropical Medicine. It is currently in Phase 3 development for Radical cure of Plasmodium vivax malaria (hypnozoite elimination), Radical cure of Plasmodium ovale malaria (hypnozoite elimination), Prevention of malaria relapse in endemic regions. Also known as: Primaquine.

PQ is a primaquine analog that acts as an 8-aminoquinoline antimalarial targeting the hypnozoite stage of Plasmodium parasites in the liver.

PQ (0.75) is a small molecule intervention used in the treatment of malaria, specifically Plasmodium Falciparum Malaria, as part of a study on primaquine's gametocytocidal efficacy. This intervention is studied in combination with dihydroartemisinin-piperaquine in a clinical trial registered on ClinicalTrials.gov as NCT01838902.

Likelihood of approval

60.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	PQ (0.75)
Also known as	Primaquine
Sponsor	London School of Hygiene and Tropical Medicine
Drug class	8-aminoquinoline antimalarial
Target	Plasmodium hypnozoite (liver stage parasite)
Modality	Small molecule
Therapeutic area	Infectious Disease / Parasitology
Phase	Phase 3

Mechanism of action

PQ (primaquine at 0.75 mg/kg dose) eliminates dormant liver forms (hypnozoites) of P. vivax and P. ovale malaria parasites, preventing relapse infections. It works by generating reactive oxygen species within infected hepatocytes, thereby achieving radical cure of these relapsing malaria species. The 0.75 dose represents a lower-dose regimen studied for improved tolerability.

Approved indications

Radical cure of Plasmodium vivax malaria (hypnozoite elimination)
Radical cure of Plasmodium ovale malaria (hypnozoite elimination)
Prevention of malaria relapse in endemic regions

Common side effects

Hemolysis in G6PD-deficient patients
Abdominal discomfort
Methemoglobinemia
Nausea

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

PQ (0.75) CI brief — competitive landscape report
PQ (0.75) updates RSS · CI watch RSS
London School of Hygiene and Tropical Medicine portfolio CI

Frequently asked questions about PQ (0.75)

What is PQ (0.75)?

PQ (0.75) is a 8-aminoquinoline antimalarial drug developed by London School of Hygiene and Tropical Medicine, indicated for Radical cure of Plasmodium vivax malaria (hypnozoite elimination), Radical cure of Plasmodium ovale malaria (hypnozoite elimination), Prevention of malaria relapse in endemic regions.

How does PQ (0.75) work?

PQ is a primaquine analog that acts as an 8-aminoquinoline antimalarial targeting the hypnozoite stage of Plasmodium parasites in the liver.

What is PQ (0.75) used for?

PQ (0.75) is indicated for Radical cure of Plasmodium vivax malaria (hypnozoite elimination), Radical cure of Plasmodium ovale malaria (hypnozoite elimination), Prevention of malaria relapse in endemic regions.

Who makes PQ (0.75)?

PQ (0.75) is developed by London School of Hygiene and Tropical Medicine (see full London School of Hygiene and Tropical Medicine pipeline at /company/london-school-of-hygiene-and-tropical-medicine).

Is PQ (0.75) also known as anything else?

PQ (0.75) is also known as Primaquine.

What drug class is PQ (0.75) in?

PQ (0.75) belongs to the 8-aminoquinoline antimalarial class. See all 8-aminoquinoline antimalarial drugs at /class/8-aminoquinoline-antimalarial.

What development phase is PQ (0.75) in?

PQ (0.75) is in Phase 3.

What are the side effects of PQ (0.75)?

Common side effects of PQ (0.75) include Hemolysis in G6PD-deficient patients, Abdominal discomfort, Methemoglobinemia, Nausea.

What does PQ (0.75) target?

PQ (0.75) targets Plasmodium hypnozoite (liver stage parasite) and is a 8-aminoquinoline antimalarial.

Drug class: All 8-aminoquinoline antimalarial drugs
Target: All drugs targeting Plasmodium hypnozoite (liver stage parasite)
Manufacturer: London School of Hygiene and Tropical Medicine — full pipeline
Therapeutic area: All drugs in Infectious Disease / Parasitology
Indication: Drugs for Radical cure of Plasmodium vivax malaria (hypnozoite elimination)
Indication: Drugs for Radical cure of Plasmodium ovale malaria (hypnozoite elimination)
Indication: Drugs for Prevention of malaria relapse in endemic regions
Also known as: Primaquine

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing