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Hydroxychloroquine Pre-Exposure Prophylaxis
Hydroxychloroquine Pre-Exposure Prophylaxis is a Antimalarial/Immunomodulator Small molecule drug developed by GeoSentinel Foundation. It is currently in Phase 3 development for Pre-exposure prophylaxis for infectious disease (specific pathogen under investigation in Phase 3). Also known as: Hydroxychloroquine PreP, HCQ PreP.
Hydroxychloroquine modulates immune responses and reduces inflammatory cytokine production to prevent infection establishment.
Hydroxychloroquine modulates immune responses and reduces inflammatory cytokine production to prevent infection establishment. Used for Pre-exposure prophylaxis for infectious disease (specific pathogen under investigation in Phase 3).
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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 Pre-Exposure Prophylaxis |
|---|---|
| Also known as | Hydroxychloroquine PreP, HCQ PreP |
| Sponsor | GeoSentinel Foundation |
| Drug class | Antimalarial/Immunomodulator |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Immunology |
| Phase | Phase 3 |
Mechanism of action
Hydroxychloroquine is a quinoline antimalarial and immunomodulatory agent that increases endosomal pH, inhibits toll-like receptor signaling, and reduces production of pro-inflammatory cytokines including TNF-α and IL-6. In pre-exposure prophylaxis, it is hypothesized to prime innate immune responses and reduce viral replication capacity at mucosal surfaces, thereby preventing initial infection or reducing severity of infection upon exposure.
Approved indications
- Pre-exposure prophylaxis for infectious disease (specific pathogen under investigation in Phase 3)
Common side effects
- Gastrointestinal disturbance (nausea, diarrhea, abdominal pain)
- Headache
- Dizziness
- Retinopathy (with long-term use)
- Cardiomyopathy (rare, with prolonged use)
Key clinical trials
- Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic (PHASE3)
- COVID-19 PrEP HCW HCQ Study (PHASE2)
- Randomized Clinical Trial for the Prevention of SARS-CoV-2 Infection (COVID-19) in Healthcare Personnel (PHASE3)
- Pre-exposure Prophylaxis for SARS-Coronavirus-2 (PHASE3)
- Does Hydroxychloroquine Before & During Patient Exposure Protect Healthcare Workers From Coronavirus? (PHASE3)
- Comparative Study of Hydroxychloroquine and Ivermectin in COVID-19 Prophylaxis (NA)
- Efficacy of Various Doses of Hydroxychloroquine in Pre-Exposure Prophylaxis for COVID 19 (PHASE2)
- HEalth Care Worker pROphylaxis Against COVID-19: The HERO Trial (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 Pre-Exposure Prophylaxis CI brief — competitive landscape report
- Hydroxychloroquine Pre-Exposure Prophylaxis updates RSS · CI watch RSS
- GeoSentinel Foundation portfolio CI
Frequently asked questions about Hydroxychloroquine Pre-Exposure Prophylaxis
What is Hydroxychloroquine Pre-Exposure Prophylaxis?
How does Hydroxychloroquine Pre-Exposure Prophylaxis work?
What is Hydroxychloroquine Pre-Exposure Prophylaxis used for?
Who makes Hydroxychloroquine Pre-Exposure Prophylaxis?
Is Hydroxychloroquine Pre-Exposure Prophylaxis also known as anything else?
What drug class is Hydroxychloroquine Pre-Exposure Prophylaxis in?
What development phase is Hydroxychloroquine Pre-Exposure Prophylaxis in?
What are the side effects of Hydroxychloroquine Pre-Exposure Prophylaxis?
Related
- Drug class: All Antimalarial/Immunomodulator drugs
- Manufacturer: GeoSentinel Foundation — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Immunology
- Indication: Drugs for Pre-exposure prophylaxis for infectious disease (specific pathogen under investigation in Phase 3)
- Also known as: Hydroxychloroquine PreP, HCQ PreP
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing