Plaquenil

(Hydroxychloroquine Sulfate)

ApprovedSmall molecule

Plaquenil is a small molecule that works as a Toll-Like Receptor 7 Antagonist; Toll-Like Receptor 9 Antagonist.[2] It is being used across 11 indications, with its most advanced program in Approved.[1]

Plaquenil is one of 319 small molecule programs targeting Malaria. It is currently in Approved.

Indications

Total Trials

Active Trials

318

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

MalariaUnknown

Cutaneous Lupus ErythematosusUnknown

Systemic Lupus ErythematosusUnknown

Rheumatoid ArthritisUnknown

Coronavirus Infectious DiseaseActive, not recruiting

RhabdomyolysisActive, not recruiting

PneumoniaActive, not recruiting

Coronary Artery DiseaseActive, not recruiting

Pancreatic AdenocarcinomaRecruiting

Oral MucositisRecruiting

MalariaPreclinical

Unknown

Cutaneous Lupus ErythematosusPreclinical

Unknown

Systemic Lupus ErythematosusPreclinical

Unknown

Rheumatoid ArthritisPreclinical

Unknown

Coronavirus Infectious DiseasePreclinical

Active, not recruiting

RhabdomyolysisPreclinical

Active, not recruiting

PneumoniaPreclinical

Active, not recruiting

Coronary Artery DiseaseApproved

Active, not recruiting

Pancreatic AdenocarcinomaPhase 2

Recruiting

Oral MucositisPhase 2

Recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

181 competitors in Rheumatoid Arthritis

#DrugCompanyPhaseTrials

Plaquenil

Jazz Pharmaceuticals

Approved

36 2

Actos

Takeda

Preclinical

2 3

Celexa

AbbVie

Preclinical

1 4

Voltaren

Cataflam

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

2 7

Vancocin

HHikma Pharmaceuticals LLC

Preclinical

1 8

Disalcid

JJoslin Diabetes Center

Preclinical

—9

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Valium

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2030

Phase 1/2Recruiting

Pancreatic Adenocarcinoma

NCT04911816

Clinical

Trials by Indication[1]

COVID-1916 trials

Efficacy and Safety of Hydroxychloroquine and Azithromycin for Patients With Moderate to Severe COVID-19

Suspended·AAzidus Brasil·Phase 1·NCT04329572·400 enrolled

Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals

Unknown status·IInstituto Nacional de Rehabilitacion·Phase 1·NCT04340349·214 enrolled

Hydroxychloroquine for COVID-19

Terminated·UUniversity Hospital Tuebingen·Phase 3·NCT04342221·30 enrolled

Show 13 more trials

Prophylactic Benefit of Hydroxychloroquine in COVID-19 Cases With Mild to Moderate Symptoms and in Healthcare Workers With High Exposure Risk

Withdrawn·TTexas Cardiac Arrhythmia Research Foundation·N/A·NCT04371926

Hydroxychloroquine as Chemoprevention for COVID-19 for High Risk Healthcare Workers

Completed·HHackensack Meridian Health·Phase 2·NCT04345653·48 enrolled

Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies (HYACINTHE)

Withdrawn·IInstitut de cancérologie Strasbourg Europe·Phase 2·NCT04392128

Hydroxychloroquine and Lopinavir/ Ritonavir to Improve the Health of People With COVID-19: "The Hope Coalition - 1"

Unknown status·CCardresearch·Phase 3·NCT04403100·1,968 enrolled

Effect of Hydroxychloroquine in COVID-19 Positive Pregnant Women

Withdrawn·SSir Mortimer B. Davis - Jewish General Hospital·Phase 2·NCT04354441

PROphylaxis for paTiEnts at Risk of COVID-19 infecTion

Withdrawn·—·Phase 2/3·NCT04389359

A Preventive Treatment for Migrant Workers at High-risk of COVID-19

Completed·NNational University Hospital, Singapore·Phase 3·NCT04446104·4,257 enrolled

Treatment for COVID-19 in High-Risk Adult Outpatients

Terminated·UUniversity of Washington·Phase 2/3·NCT04354428·289 enrolled

Efficacy and Safety of Hydroxychloroquine and Azithromycin for the Treatment of Ambulatory Patients With Mild COVID-19

Suspended·AAzidus Brasil·Phase 1·NCT04348474·200 enrolled

Comparison of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)

Terminated·—·Phase 2·NCT04307693·65 enrolled

Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP)

Completed·UUniversity of Washington·Phase 2/3·NCT04328961·943 enrolled

Randomized Comparison of Combination Azithromycin and Hydroxychloroquine vs. Hydroxychloroquine Alone for the Treatment of Confirmed COVID-19

Terminated·RRutgers, The State University of New Jersey·Phase 2·NCT04336332·75 enrolled

Efficacy and Tolerability of Hydroxychloroquine in Adult Patients With COVID-19

Completed·TTaoyuan General Hospital·N/A·NCT04384380·33 enrolled

IgA Nephropathy3 trials

Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy

Unknown status·PPeking Union Medical College Hospital·Phase 4·NCT02765594·98 enrolled

A Study of Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy

Completed·PPeking University First Hospital·Phase 2·NCT02942381·60 enrolled

Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy: a Self- Controlled Study

Completed·LLLiu·Phase 4·NCT02351752·20 enrolled

Age1 trial

Study on Optimization and Evaluation of Integrated Chinese and Western Medicine for pSS Glandular Damage

Enrolling by invitation·QQingwen Tao·Phase 2·NCT06519617·136 enrolled

Pancreatic Cancer1 trial

LY3214996 +/- HCQ in Pancreatic Cancer

Completed·—·Phase 2·NCT04386057·52 enrolled

Coronavirus Disease 20191 trial

Norwegian Coronavirus Disease 2019 Study

Unknown status·UUniversity Hospital, Akershus·Phase 4·NCT04316377·53 enrolled

14 more indications

Interstitial Lung Disease1 trial

Hydroxychloroquine (HCQ) in Pediatric Interstitial Lung Disease (ILD)

Terminated·MMatthias Griese·Phase 2·NCT02615938·35 enrolled

Pneumonia1 trial

Low Dose Anti-inflammatory Radiotherapy for the Treatment of Pneumonia by COVID-19

Unknown status·GGrupo de Investigación Clínica en Oncología Radioterapia·N/A·NCT04380818·106 enrolled

Azithromycin1 trial

Hydroxychloroquine,Hydroxychloroquine,Azithromycin in the Treatment of SARS CoV-2 Infection

Terminated·WWashington University School of Medicine·Phase 3·NCT04341727·30 enrolled

Antiphospholipid Syndrome1 trial

A Study of Hydroxychloroquine Sulfate in the Treatment of Recurrent Spontaneous Abortion With Antiphospholipid Syndrome

Unknown status·SShanghai First Maternity and Infant Hospital·Phase 4·NCT04624269·384 enrolled

Prophylaxis1 trial

Efficacy of Various Doses of Hydroxychloroquine in Pre-Exposure Prophylaxis for COVID 19

Unknown status·SShaheed Zulfiqar Ali Bhutto Medical University·Phase 2·NCT04359537·200 enrolled

Recruiting·XXingchen Peng·Phase 1/2·NCT06939582·158 enrolled

Cholangiocarcinoma1 trial

A Study of ABC294640 Alone and in Combination With HCQ Sulfate in the Treatment of Advanced Cholangiocarcinoma

Completed·RRedHill Biopharma Limited·Phase 2·NCT03377179·65 enrolled

Coronary Artery Disease1 trial

Efficacy Study of Hydroxychloroquine to Treat High-risk Coronary Artery Disease.

Completed·FFirst Affiliated Hospital Xi'an Jiaotong University·Phase 4·NCT02874287·35 enrolled

Rhabdomyolysis1 trial

Acute Rhabdomyolysis and Muscle Pain Associated With Mutations in the LPIN1 Gene - A Retrospective Study Describing the Safety and Efficacy of Hydroxychloroquine Sulfate Given on a Compassionate Basis to Patients Suffering From Lipin-1 Deficiency

Withdrawn·AAssistance Publique - Hôpitaux de Paris··NCT04007562

Pancreatic Adenocarcinoma1 trial

Neoadjuvant mFOLFIRINOX With Perioperative Oral Hydroxychloroquine in Resectable Pancreatic Adenocarcinoma

Recruiting·WWest Virginia University·Phase 1/2·NCT04911816·40 enrolled

Corona Virus Infection1 trial

Hydroxychloroquine or Hydroxychloroquine Associated With Azithromycin for Inpatients With Moderate or Severe Lung Disease Due to SARS-CoV-2 (COVID-19)

Withdrawn·AApsen Farmaceutica S.A.·Phase 3·NCT04361461

Unspecified1 trial

To Demonstrate the Relative Bioavailability of Hydroxychloroquine Sulfate, 200 mg Tablets

Completed· Novartis logo

Novartis·Phase 1·NCT00946790·72 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

PLAQUENIL

NDA NDA009768

Jan 14, 2022

SOVUNA

NDA NDA214581

Sources

References

[1]
ClinicalTrials.gov — 36 trial records for Hydroxychloroquine Sulfate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Hydroxychloroquine Sulfate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Hydroxychloroquine Sulfate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA214581). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Jazz Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Toll-Like Receptor 7 Antagonist; Toll-Like Receptor 9 Antagonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Jazz Pharmaceuticals

Plaquenil

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2030

Trials by Indication[1]

COVID-1916 trials

IgA Nephropathy3 trials

Age1 trial

Pancreatic Cancer1 trial

Coronavirus Disease 20191 trial

Interstitial Lung Disease1 trial

Pneumonia1 trial

Azithromycin1 trial

Antiphospholipid Syndrome1 trial

Prophylaxis1 trial

Primary Sjögren's Syndrome1 trial

Atrial Fibrillation1 trial

Oral Mucositis1 trial

Cholangiocarcinoma1 trial

Coronary Artery Disease1 trial

Rhabdomyolysis1 trial

Pancreatic Adenocarcinoma1 trial

Corona Virus Infection1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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