Lampit

(Nifurtimox)

Phase 3Small molecule

Bayer

Lampit is one of 108 small molecule programs targeting Human African Trypanosomiasis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

107

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Human African TrypanosomiasisActive, not recruiting

NeuroblastomaActive, not recruiting

Infectious DiseaseActive, not recruiting

MedulloblastomaActive, not recruiting

TrypanosomiasisActive, not recruiting

Human African TrypanosomiasisPhase 2/Phase 3

Active, not recruiting

NeuroblastomaPhase 1

Active, not recruiting

Infectious DiseasePhase 3

Active, not recruiting

MedulloblastomaPhase 2

Active, not recruiting

TrypanosomiasisPhase 2/Phase 3

Active, not recruiting

Competition

Competitive Landscape

237 competitors in Neuroblastoma

#DrugCompanyPhaseTrials

Leukine

Sanofi

Phase 3

18 2

Paraplatin

AAvyxa

Phase 3

38 3

Cytoxan

BBaxter Healthcare Corporation

Phase 3

54 4

Vepesid

AAvyxa

Phase 3

42 5

Camptosar

Pfizer

Phase 3

13 6

Tepadina

Alnylam Pharmaceuticals

Phase 3

12 7

Alkeran

AApotex Inc.

Phase 3

28 8

Accutane

CConrado Roberto Hoffmann Filho

Phase 3

28 9

Oncovin

EEastern Cooperative Oncology Group

Adriamycin

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

Timeline

Expected Milestones

Q1 2032

Not yet recruiting

Chagas Disease

NCT05477953

Clinical

Trials by Indication[1]

Chronic3 trials

Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas' Patients - Dietary Habits Study

Completed· Bayer logo

Bayer·Phase 1·NCT03334838·36 enrolled

Study to Assess the Food Effect on the Pharmacokinetics of Nifurtimox Tablets in Chronic Chagas' Patients

Completed· Bayer logo

Bayer·Phase 1·NCT02606864·36 enrolled

Study to Assess Bioequivalence of 30 and 120 mg Nifurtimox Tablets in Chronic Chagas' Patients

Completed· Bayer logo

Bayer·Phase 1·NCT01927224·37 enrolled

Human African Trypanosomiasis2 trials

Efficacy - Safety of Eflornithine-Nifurtimox Combination Versus Eflornithine to Treat Human African Trypanosomiasis

Completed·DDrugs for Neglected Diseases·Phase 3·NCT00146627·280 enrolled

Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2

Completed·DDrugs for Neglected Diseases·Phase 2/3·NCT01685827·394 enrolled

Neuroblastoma1 trial

Safety Study of Nifurtimox for Relapsed or Refractory Neuroblastoma

Completed·UUniversity of Vermont·Phase 1·NCT00486564·20 enrolled

Biomarkers1 trial

New Therapies and Biomarkers for Chagas Infection

Completed·—·Phase 2·NCT03981523·450 enrolled

Single Dose1 trial

Study Will Evaluate the Relative Bioavailability, Safety, and Tolerability of Single Doses of Nifurtimox 30 mg Tablets Exhibiting Different in Vitro Dissolution Characteristics, and to Evaluate the Relative Bioavailability of Nifurtimox 30 mg and 120 mg

Completed· Bayer logo

Bayer·Phase 1·NCT03350295·48 enrolled

4 more indications

Infectious Disease1 trial

A Study to Learn How Well Nifurtimox Works and How Safe it is in Children Aged 0 to 17 Years With Chagas' Disease, an Inflammatory, Infectious Disease Caused by the Parasite Trypanosoma Cruzi

Completed· Bayer logo

Bayer·Phase 3·NCT02625974·330 enrolled

Medulloblastoma1 trial

Study of Nifurtimox to Treat Refractory or Relapsed Neuroblastoma or Medulloblastoma

Completed·GGiselle Sholler·Phase 2·NCT00601003·112 enrolled

Trypanosomiasis1 trial

CHICAMOCHA 3 - Equivalence of Usual Interventions for Trypanosomiasis (EQUITY)

Unknown status·UUniversidad Autónoma de Bucaramanga·Phase 2/3·NCT02369978·500 enrolled

Chagas disease1 trial

Observational Pregnancy Safety Study of Women Exposed to Nifurtimox During Pregnancy to Describe the Risk of Pregnancy and Maternal Complications and Other Events of Interest on the Developing Fetus, Neonate, and Infant

Not yet recruiting· Bayer logo

Bayer··NCT05477953·50 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 6, 2020

LAMPIT

NDA NDA213464

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for Nifurtimox. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Nifurtimox compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Nifurtimox. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA213464). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Bayer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Bayer

Lampit

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2032

Trials by Indication[1]

Chronic3 trials

Human African Trypanosomiasis2 trials

Neuroblastoma1 trial

Biomarkers1 trial

Single Dose1 trial

Infectious Disease1 trial

Medulloblastoma1 trial

Trypanosomiasis1 trial

Chagas disease1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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