PQ (0.4)

London School of Hygiene and Tropical Medicine · Phase 3 active Small molecule

PQ (0.4) is a 8-aminoquinoline 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, Treatment of Plasmodium ovale malaria. Also known as: Primaquine.

PQ (0.4) is an antimalarial drug that works by disrupting the parasite's ability to metabolize heme, leading to its death.

PQ (0.4) is an antimalarial drug that works by disrupting the parasite's ability to metabolize heme, leading to its death. Used for Radical cure of Plasmodium vivax malaria, Treatment of Plasmodium ovale malaria.

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 (0.4)
Also known as	Primaquine
Sponsor	London School of Hygiene and Tropical Medicine
Drug class	8-aminoquinoline
Target	Heme
Modality	Small molecule
Therapeutic area	Infectious Diseases
Phase	Phase 3

Mechanism of action

PQ (0.4) specifically targets the heme detoxification pathway in Plasmodium parasites, converting heme into hemozoin, which is toxic to the parasite. This action leads to the destruction of the parasite within the host's red blood cells.

Approved indications

• Radical cure of Plasmodium vivax malaria
• Treatment of Plasmodium ovale malaria

Common side effects

• Gastrointestinal disturbances
• Headache

Key clinical trials

• Primaquine's Gametocytocidal Efficacy in Malaria Asymptomatic Carriers (PHASE3)
• Evaluation of the Safety of Primaquine in Combination With Dihydroartemisinin-piperaquine in G6PD Deficient Males in The Gambia (PHASE2, PHASE3)
• Safety of Primaquine + Artemether-lumefantrine in G6PD Deficient Males With an Asymptomatic Malaria Infection (SAFEPRIM) (PHASE2, PHASE3)

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 (0.4) CI brief — competitive landscape report
• PQ (0.4) updates RSS · CI watch RSS
• London School of Hygiene and Tropical Medicine portfolio CI

Frequently asked questions about PQ (0.4)

What is PQ (0.4)?

PQ (0.4) is a 8-aminoquinoline drug developed by London School of Hygiene and Tropical Medicine, indicated for Radical cure of Plasmodium vivax malaria, Treatment of Plasmodium ovale malaria.

How does PQ (0.4) work?

PQ (0.4) is an antimalarial drug that works by disrupting the parasite's ability to metabolize heme, leading to its death.

What is PQ (0.4) used for?

PQ (0.4) is indicated for Radical cure of Plasmodium vivax malaria, Treatment of Plasmodium ovale malaria.

Who makes PQ (0.4)?

PQ (0.4) 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 (0.4) also known as anything else?

PQ (0.4) is also known as Primaquine.

What drug class is PQ (0.4) in?

PQ (0.4) belongs to the 8-aminoquinoline class. See all 8-aminoquinoline drugs at /class/8-aminoquinoline.

What development phase is PQ (0.4) in?

PQ (0.4) is in Phase 3.

What are the side effects of PQ (0.4)?

Common side effects of PQ (0.4) include Gastrointestinal disturbances, Headache.

What does PQ (0.4) target?

PQ (0.4) targets Heme and is a 8-aminoquinoline.

Related

• Drug class: All 8-aminoquinoline drugs
• Target: All drugs targeting Heme
• Manufacturer: London School of Hygiene and Tropical Medicine — full pipeline
• Therapeutic area: All drugs in Infectious Diseases
• Indication: Drugs for Radical cure of Plasmodium vivax malaria
• Indication: Drugs for Treatment of Plasmodium ovale malaria
• Also known as: Primaquine