Chloroquine Hydrochloride

Sold as Aralen Hydrochloride. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Chloroquine Hydrochloride (sold as Aralen Hydrochloride), first approved Oct 31, 1949, with 0 new uses approved and 0 published complete response letters.

First approved: Oct 31, 1949
Applications: 1
New uses approved: 0
Complete response letters: 0

FDA Drug Safety Communications

One communication since 2020 that name this drug; see all communications

FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problemsApr 24, 2020

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

Treatment of glioblastoma multiforme.DualTpharma B.,V. · designated May 20, 2015

Clinical Trials

73 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Systemic and Topical Geroprotective Rejuvenation Assessed by START/REST Aging ClocksAging · Frontiers in Bioscience Research Institute and Aging	Early phase 1	Enrolling by invitation	Oct 22, 2026
Ethiopian Antimalarial Therapeutic Efficacy Study 2026Plasmodium Vivax Malaria Without Complication, Plasmodium Falciparum Malaria (Uncomplicated) · Ethiopian Public Health Institute	—	Not yet recruiting	Sep 25, 2026
Tafenoquine Drug Levels in Small ChildrenPlasmodium Vivax Malaria, Vivax Malaria · University of Oxford	Phase 2	Not yet recruiting	Sep 22, 2026
ACT4RHD is an Open-label, Randomised, Adaptive Platform Trial to Evaluate Novel and Repurposed Clinical Interventions for Patients With Acute Rheumatic Fever and Carditis. ACT4RHD Seeks to Determine Whether These Interventions Reduce RHD Severity at 6 Months.Rheumatic Fever, Rheumatic Heart Disease in Children · Starship Child Health, Te Toka Tumai Auckland	Phase 3	Not yet recruiting	Sep 21, 2026
Pilot Study of Hydroxychloroquine for the Treatment of AIMSSAromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS), Joint Pain · Indiana University	Phase 2	Recruiting	Sep 17, 2026
Hydrochloroquinine & Decitabine With Venetoclax in AMLAcute Myeloid Leukemia · Rutgers, The State University of New Jersey	Phase 1	Not yet recruiting	Sep 10, 2026
Tunlametinib in Combination With Pucotenlimab and Hydroxychloroquine in NRAS Mutant MelanomaMelanoma Metastatic, NRAS Mutation · Sun Yat-sen University	Phase 2	Recruiting	Aug 6, 2026
The Effect of Nicorandil on Rheumatoid Arthritis PatientsRheumatoid Arthritis (RA) · Ain Shams University	Phase 2 / Phase 3	Recruiting	Jul 28, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Oct 31, 1949	Aralen, Aralen HydrochlorideNDA 6002	Sanofi Aventis US	27	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA