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Mepron

(Atovaquone)

ApprovedSmall molecule

GGlaxo Dba Glaxosmithkline

Atovaquone is an antiprotozoal medication used to treat and prevent a type of pneumonia called Pneumocystis jiroveci pneumonia (PCP) that commonly affects people with HIV. It works by stopping the growth of harmful organisms called protozoa that cause this infection.[2] Mepron is currently approved and in use across 13 indications[4].[1]

Mepron is one of 317 small molecule programs targeting Pneumocystosis. It is currently in Approved.

13

Indications

18

Total Trials

3

Active Trials

316

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

PneumocystosisActive, not recruiting

Plasmodium Falciparum MalariaApproved

MalariaActive, not recruiting

Fungal Infectious DiseaseActive, not recruiting

PneumoniaActive, not recruiting

ImmunodeficiencyActive, not recruiting

EncephalitisActive, not recruiting

Non-Small Cell Lung CancerApproved

Ovarian CancerActive, not recruiting

Acute Myeloid LeukemiaActive, not recruiting

PneumocystosisApproved

Active, not recruiting

Plasmodium Falciparum MalariaApproved

Approved

MalariaApproved

Active, not recruiting

Fungal Infectious DiseaseApproved

Active, not recruiting

PneumoniaPhase 3

Active, not recruiting

ImmunodeficiencyPreclinical

Active, not recruiting

EncephalitisPhase 2

Active, not recruiting

Non-Small Cell Lung CancerApproved

Approved

Ovarian CancerPhase 2

Active, not recruiting

Acute Myeloid LeukemiaPhase 1

Active, not recruiting

Showing 10 of 13 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Mepron

GGlaxo Dba Glaxosmithkline

Singulair

Calciferol

Alnylam Pharmaceuticals

Tricor

Nitrostat

VViatris Specialty LLC

Proventil

Mylan Pharmaceuticals Inc

SARS-COV-2 VACCINE

Statin

Bristol-Myers Squibb

Orap

Biological Data

UUniversity Hospital, Bordeaux

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

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Ovarian Cancer

NCT05998135

Q4 2027

Phase 1Recruiting

Malignant Brain Tumors

NCT06624371

Q3 2029

Post-ApprovalNot yet recruiting

Pneumonia

NCT07357103

Clinical

Trials by Indication[1]

Pneumonia5 trials

A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000655·300 enrolled

A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients Who Are Intolerant of Trimethoprim / Sulfamethoxazole

Completed· GSK logo

GSK·Phase 2·NCT00001996

A Treatment IND for 566C80 Therapy of Pneumocystis Carinii Pneumonia

Completed· GSK logo

GSK·N/A·NCT00001991

Show 2 more trials

Positioning Second-line Therapies for Pneumocystis Jirovecii Pneumonia (PCP Alternatives)

Not yet recruiting·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 4·NCT07357103·416 enrolled

A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX

Completed· GSK logo

GSK·Phase 3·NCT00002340·615 enrolled

Oral1 trial

Single Oral Dose Study of Atovaquone/Proguanil Hydrochloride Combination Tablets and Atovaquone Suspension

Completed· GSK logo

GSK·Phase 1·NCT01858831·30 enrolled

Bacterial Infections1 trial

A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000811·690 enrolled

Prophylaxis1 trial

A Randomized, Comparative Study of Daily Dapsone and Daily Atovaquone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant of Trimethoprim and/or Sulfonamides

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000802·700 enrolled

Ovarian Cancer1 trial

Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer

Recruiting·EEmory University·Phase 2·NCT05998135·28 enrolled

9 more indications

Immunodeficiency1 trial

A Pilot Study of 566C80 for the Salvage Treatment of Toxoplasmic Encephalitis in Patients Infected With the Human Immunodeficiency Virus (HIV) Who Have Failed or Are Intolerant of Pyrimethamine-Sulfadiazine

Completed· GSK logo

GSK·N/A·NCT00001994

Interaction1 trial

Antiretroviral Drug Interaction Study in Volunteers With HIV

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 1·NCT01479361·36 enrolled

Chemoradiotherapy1 trial

Atovaquone With Radical ChemorADIotherapy in Locally Advanced NSCLC

Completed·UUniversity of Oxford·Phase 1·NCT04648033·21 enrolled

Clinical Trial1 trial

An Open-Label, Uncontrolled Clinical Trial of Oral 566C80 for the Treatment of Patients With Severe PCP Who Are Intolerant and/or Unresponsive to Therapy With Trimethoprim/Sulfamethoxazole and Parenteral Pentamidine

Completed· GSK logo

GSK·N/A·NCT00001990

Encephalitis1 trial

Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00000794·100 enrolled

Children1 trial

Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000773·24 enrolled

Hypoxia1 trial

Atovaquone as Tumour HypOxia Modifier

Completed·UUniversity of Oxford·Phase 1·NCT02628080·46 enrolled

Malignant Brain Tumors1 trial

Atovaquone Combined With Radiation in Children With Malignant Brain Tumors

Recruiting·EEmory University·Phase 1·NCT06624371·18 enrolled

Acute Myeloid Leukemia1 trial

A Trial of Atovaquone (Mepron®) Combined With Conventional Chemotherapy for de Novo Acute Myeloid Leukemia (AML) in Children, Adolescents, and Young Adults (ATACC AML)

Completed·BBaylor College of Medicine·Phase 1·NCT03568994·26 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 25, 1992

MEPRON

NDA NDA020259

Feb 8, 1995

MEPRON

NDA NDA020500

Sources

References

[1]
ClinicalTrials.gov — 18 trial records for Atovaquone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Mepron drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Atovaquone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Atovaquone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020500). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Glaxo Dba Glaxosmithkline company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cytochrome B Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: GGlaxo Dba Glaxosmithkline

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