ARALEN (chloroquine phosphate) · Sanofi
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1949-10-31
- Routes
- ORAL
- Dosage Forms
- TABLET
ARALEN Approval History
What ARALEN Treats
1 FDA approvalsOriginally approved for its first indication in 1949 .
- Other (1)
Other
(1 approval)- • Approved indication (Oct 1949)
Sanofi's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
7 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06076837 | HRI-2023 Magnificent 7 | Ph 1 | terminated | The Seven Trial: Exploiting the Unfolded Protein Response |
| NCT03952650 results posted | 999919099 19-I-N099 | Ph 1, Ph 2 | completed | Sanaria PfSPZ Challenge With Pyrimethamine or Chloroquine Chemoprophylaxis Vaccination (PfSPZ-CVac Approach): A Randomized Double Blind Placebo Controlled Phase I/II Trial to Determine Safety and Protective Efficacy Against Natural Plasmodium Falcipa... |
| NCT03083847 results posted | 170067 17-I-0067 | Ph 1 | completed | Dose Escalation PfSPZ-CVac |
| NCT04328493 VICO | COVID | Ph 2 | completed | The Vietnam Chloroquine Treatment on COVID-19 |
| NCT04331600 | WROCLAW CORONA STUDY 2020 | Ph 4 | completed | Chloroquine as Antiviral Treatment in Coronavirus Infection 2020 |
| NCT02932007 | Chloroquine AF | Ph 2 | recruiting | Chloroquine for Patients With Symptomatic Persistent Atrial Fibrillation: A Prospective Pilot Study |
| NCT02394197 EMTM | INSP CI-624 PAHO-MEX/07/005015, PAHOERC-162-MEX | Ph 4 | completed | Effectiveness of Malaria Treatment in Mexico |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ARALEN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment