Chloroquine Phosphate

Sold as Aralen. Every FDA application for this active ingredient: 1 branded and 13 generic.

As of Nov 15, 2026, FDA lists 14 applications for Chloroquine Phosphate (sold as Aralen), first approved Oct 31, 1949, with 0 new uses approved and 0 published complete response letters.

First approved: Oct 31, 1949
Applications: 14
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $388K

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Chloroquine Phosphate	Part D	$388K	-3%	1,422

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


Oct 31, 1949	Aralen, Aralen HydrochlorideNDA 6002	Sanofi Aventis US	27	Discontinued
Dec 11, 1974	Chloroquine PhosphateANDA 80880	Impax Labs	10	Marketed
Jul 9, 1975	Chloroquine PhosphateANDA 83082	Hikma	29	Discontinued
Jan 13, 1982	Chloroquine PhosphateANDA 87504	Teva	16	Discontinued
Dec 21, 1982	Chloroquine PhosphateANDA 87979	Watson Labs	13	Discontinued
Dec 21, 1982	Chloroquine PhosphateANDA 88030	Watson Labs	15	Discontinued
Aug 29, 2003	Chloroquine PhosphateANDA 40516	Impax Labs	5	Marketed
Dec 3, 2009	Chloroquine PhosphateANDA 90249	Ipca Labs Ltd	6	Discontinued
Dec 3, 2009	Chloroquine PhosphateANDA 90610	Ipca Labs Ltd	6	Discontinued
Jan 21, 2011	Chloroquine PhosphateANDA 90612	Natco Pharma Ltd	5	Marketed
Jan 21, 2011	Chloroquine PhosphateANDA 91621	Natco Pharma Ltd	4	Marketed
Sep 3, 2021	Chloroquine PhosphateANDA 214756	Cohance Lifesciences	4	Marketed
—	Chloroquine PhosphateANDA 80886	Purepac Pharm	0	Discontinued
—	Chloroquine PhosphateANDA 87228	Md Pharm	0	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