Last reviewed 2026-04-23 · How we verify

hydroxychloroquine (Z0188)

Sanofi · Phase 3 active Small molecule

hydroxychloroquine (Z0188) is a Antimalarial Small molecule drug developed by Sanofi. It is currently in Phase 3 development for Malaria, Rheumatoid Arthritis, Systemic Lupus Erythematosus. Also known as: Plaquenil®.

Hydroxychloroquine is an antimalarial drug that works by inhibiting the growth and replication of Plasmodium parasites in the red blood cells.

Hydroxychloroquine is an antimalarial drug that works by inhibiting the growth and replication of Plasmodium parasites in the red blood cells. Used for Malaria, Rheumatoid Arthritis, Systemic Lupus Erythematosus.

Likelihood of approval

63.3% 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.
Big-pharma sponsor +3.0pp
Sanofi is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

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	hydroxychloroquine (Z0188)
Also known as	Plaquenil®
Sponsor	Sanofi
Drug class	Antimalarial
Target	Plasmodium
Modality	Small molecule
Therapeutic area	Infectious Diseases
Phase	Phase 3

Mechanism of action

It does this by interfering with the parasite's ability to digest hemoglobin, which is necessary for its survival. Hydroxychloroquine has also been found to have immunomodulatory effects, which may contribute to its therapeutic benefits in autoimmune diseases.

Approved indications

Malaria
Rheumatoid Arthritis
Systemic Lupus Erythematosus

Common side effects

Retinal toxicity
Hearing loss
Cardiac arrhythmias

Key clinical trials

Multicenter Study Assessing the Efficacy & Safety of Hydroxychloroquine Sulfate in Patients With Systemic Lupus Erythematosus or Cutaneous Lupus Erythematosus With Active Lupus Erythematosus Specific Skin Lesion (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:

hydroxychloroquine (Z0188) CI brief — competitive landscape report
hydroxychloroquine (Z0188) updates RSS · CI watch RSS
Sanofi portfolio CI

Frequently asked questions about hydroxychloroquine (Z0188)

What is hydroxychloroquine (Z0188)?

hydroxychloroquine (Z0188) is a Antimalarial drug developed by Sanofi, indicated for Malaria, Rheumatoid Arthritis, Systemic Lupus Erythematosus.

How does hydroxychloroquine (Z0188) work?

Hydroxychloroquine is an antimalarial drug that works by inhibiting the growth and replication of Plasmodium parasites in the red blood cells.

What is hydroxychloroquine (Z0188) used for?

hydroxychloroquine (Z0188) is indicated for Malaria, Rheumatoid Arthritis, Systemic Lupus Erythematosus.

Who makes hydroxychloroquine (Z0188)?

hydroxychloroquine (Z0188) is developed by Sanofi (see full Sanofi pipeline at /company/sanofi).

Is hydroxychloroquine (Z0188) also known as anything else?

hydroxychloroquine (Z0188) is also known as Plaquenil®.

What drug class is hydroxychloroquine (Z0188) in?

hydroxychloroquine (Z0188) belongs to the Antimalarial class. See all Antimalarial drugs at /class/antimalarial.

What development phase is hydroxychloroquine (Z0188) in?

hydroxychloroquine (Z0188) is in Phase 3.

What are the side effects of hydroxychloroquine (Z0188)?

Common side effects of hydroxychloroquine (Z0188) include Retinal toxicity, Hearing loss, Cardiac arrhythmias.

What does hydroxychloroquine (Z0188) target?

hydroxychloroquine (Z0188) targets Plasmodium and is a Antimalarial.

Drug class: All Antimalarial drugs
Target: All drugs targeting Plasmodium
Manufacturer: Sanofi — full pipeline
Therapeutic area: All drugs in Infectious Diseases
Indication: Drugs for Malaria
Indication: Drugs for Rheumatoid Arthritis
Indication: Drugs for Systemic Lupus Erythematosus
Also known as: Plaquenil®

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