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Hydroxychloroquine (HCQ)
Hydroxychloroquine (HCQ) is a Antimalarial immunomodulator Small molecule drug developed by Post Graduate Institute of Medical Education and Research, Chandigarh. It is currently in Phase 3 development for Systemic lupus erythematosus (SLE), Rheumatoid arthritis, Malaria prophylaxis and treatment. Also known as: Plaquenil, Plaquenil®.
Hydroxychloroquine is a quinoline antimalarial and immunomodulatory agent that inhibits toll-like receptor signaling and reduces inflammatory cytokine production.
Hydroxychloroquine is a quinoline antimalarial and immunomodulatory agent that inhibits toll-like receptor signaling and reduces inflammatory cytokine production. Used for Systemic lupus erythematosus (SLE), Rheumatoid arthritis, Malaria prophylaxis and treatment.
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 (HCQ) |
|---|---|
| Also known as | Plaquenil, Plaquenil® |
| Sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh |
| Drug class | Antimalarial immunomodulator |
| Target | TLR7, TLR9, and lysosomal pH-dependent pathways |
| Modality | Small molecule |
| Therapeutic area | Immunology, Rheumatology |
| Phase | Phase 3 |
Mechanism of action
HCQ accumulates in lysosomes and endosomes, inhibiting TLR7 and TLR9 signaling pathways that drive autoimmune responses. It also reduces antigen presentation and T-cell activation, making it effective in autoimmune and inflammatory conditions. Additionally, it has antimicrobial properties and may interfere with viral entry mechanisms.
Approved indications
- Systemic lupus erythematosus (SLE)
- Rheumatoid arthritis
- Malaria prophylaxis and treatment
- Sjögren's syndrome
Common side effects
- Retinopathy
- Gastrointestinal disturbance (nausea, diarrhea)
- Headache
- Dizziness
- Pruritus
- Cardiomyopathy (rare, with prolonged use)
Key clinical trials
- Akt Inhibitor MK2206 and Hydroxychloroquine in Treating Patients With Advanced Solid Tumors, Melanoma, Prostate or Kidney Cancer (PHASE1)
- Venlafaxine as Adjunct Therapy in Rheumatoid Arthritis (PHASE2)
- Genotype-Phenotype Study of Patients With Plaquenil -Induced Retinal Toxicity, With Evaluation of the ABCA4 Gene
- Safety and Effect on Pain and Function According to RAPID-3 of IHL-675A in Patients With Rheumatoid Arthritis (PHASE2)
- The Efficacy and Safety of Anti-inflammation Treatment (Hirudoid Introduction Followed by Yellow Light Therapy) Combined With Tofacitinib and Doxycycline in Chinese Adult Patients With Mild to Moderate Erythematous Telangiectatic Rosacea (NA)
- Hydroxychloroquin (HCQ) in chILD of Genetic Defect (NA)
- A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies (PHASE1)
- Hydroxychloroquine in Children's Interstitial Lung Diseases With Genetic Causes (EARLY_PHASE1)
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 (HCQ) CI brief — competitive landscape report
- Hydroxychloroquine (HCQ) updates RSS · CI watch RSS
- Post Graduate Institute of Medical Education and Research, Chandigarh portfolio CI
Frequently asked questions about Hydroxychloroquine (HCQ)
What is Hydroxychloroquine (HCQ)?
How does Hydroxychloroquine (HCQ) work?
What is Hydroxychloroquine (HCQ) used for?
Who makes Hydroxychloroquine (HCQ)?
Is Hydroxychloroquine (HCQ) also known as anything else?
What drug class is Hydroxychloroquine (HCQ) in?
What development phase is Hydroxychloroquine (HCQ) in?
What are the side effects of Hydroxychloroquine (HCQ)?
What does Hydroxychloroquine (HCQ) target?
Related
- Drug class: All Antimalarial immunomodulator drugs
- Target: All drugs targeting TLR7, TLR9, and lysosomal pH-dependent pathways
- Manufacturer: Post Graduate Institute of Medical Education and Research, Chandigarh — full pipeline
- Therapeutic area: All drugs in Immunology, Rheumatology
- Indication: Drugs for Systemic lupus erythematosus (SLE)
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Malaria prophylaxis and treatment
- Also known as: Plaquenil, Plaquenil®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing