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Monopar Therapeutics

🇺🇸United States
Ownership
-
Employees
10
Market Cap
$8.4M
Website
Introduction

Monopar Therapeutics, Inc. is a clinical stage biopharmaceutical company, which engages in developing proprietary therapeutics for cancer patients. It also focuses on building a drug development pipeline through the licensing, and acquisition of therapeutics in late preclinical and clinical development stages. The company was founded by Chandler Drew Robinson, Christopher M. Starr and Andrew P. Mazar in December 2014 and is headquartered in Wilmette, IL.

Clinical Trials

6

Active:0
Completed:0

Trial Phases

2 Phases

Phase 1:3
Phase 2:1

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (4 trials with phase data)• Click on a phase to view related trials

Phase 1
3 (75.0%)
Phase 2
1 (25.0%)

MNPR-101-PCTA-177Lu Expanded Access Program (EAP) for Patients With Solid Tumor Cancer

Conditions
Cancer
Solid Tumor
Solid Tumor Cancer
Oncology
uPAR-positive Solid Tumor
Urokinase Plasminogen Activator Receptor-positive Solid Tumor
First Posted Date
2025-05-20
Last Posted Date
2025-05-22
Lead Sponsor
Monopar Therapeutics
Registration Number
NCT06980519
Locations
🇺🇸

Excel Diagnostics & Nuclear Oncology Center, Houston, Texas, United States

MNPR-101-DFO*-89Zr Expanded Access Program (EAP) for Patients With Solid Tumor Cancer

Conditions
Cancer
Solid Tumor
Solid Tumor, Adult
First Posted Date
2025-05-20
Last Posted Date
2025-05-22
Lead Sponsor
Monopar Therapeutics
Registration Number
NCT06980506
Locations
🇺🇸

Excel Diagnostics & Nuclear Oncology Center, Houston, Texas, United States

Dose-Escalation of MNPR-101-PCTA-177Lu in Solid Tumors

Phase 1
Recruiting
Conditions
Solid Tumor, Adult
Bladder Cancer
Urothelial Carcinoma
Triple-negative Breast Cancer
Lung Cancer
Colorectal Cancer
Gastric Cancer
Ovarian Cancer
Pancreatic Cancer
Interventions
First Posted Date
2024-09-27
Last Posted Date
2025-05-21
Lead Sponsor
Monopar Therapeutics
Target Recruit Count
12
Registration Number
NCT06617169
Locations
🇦🇺

Melbourne Theranostic Innovation Centre (MTIC), North Melbourne, Victoria, Australia

Diagnostic Efficacy and Dosimetry of MNPR-101-DFO*-89Zr in Patients With Solid Tumors

Phase 1
Recruiting
Conditions
Ovarian Cancer
Pancreatic Cancer
Solid Tumor, Adult
Bladder Cancer
Urothelial Carcinoma
Triple-negative Breast Cancer
Lung Cancer
Colorectal Cancer
Gastric Cancer
Interventions
Diagnostic Test: PET/CT Diagnostic Imaging
First Posted Date
2024-03-29
Last Posted Date
2025-05-22
Lead Sponsor
Monopar Therapeutics
Target Recruit Count
12
Registration Number
NCT06337084
Locations
🇦🇺

Melbourne Theranostic Innovation Centre (MTIC), North Melbourne, Victoria, Australia

Camsirubicin + Pegfilgrastim to Determine MTD in ASTS

Phase 1
Terminated
Conditions
Advanced Soft-tissue Sarcoma
Interventions
First Posted Date
2021-09-14
Last Posted Date
2024-05-16
Lead Sponsor
Monopar Therapeutics
Target Recruit Count
14
Registration Number
NCT05043649
Locations
🇺🇸

Sarcoma Oncology Center, Santa Monica, California, United States

🇺🇸

University of Washington Medicine Fred Hutchinson Cancer Center, Seattle, Washington, United States

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News

Monopar Therapeutics Launches FDA-Authorized Expanded Access Program for uPAR-Targeted Radiopharmaceuticals in Advanced Cancers

Monopar Therapeutics and EDNOC have received FDA authorization for an expanded access program providing MNPR-101-Zr imaging agent and MNPR-101-Lu therapeutic agent to patients with advanced solid tumors.

ALXN1840 Shows Promising Long-Term Efficacy and Safety for Wilson Disease at EASL 2025

• Monopar Therapeutics presented late-breaker data at EASL 2025 showing sustained clinical improvements in Wilson disease patients treated with ALXN1840 (tiomolybdate choline) over a median treatment duration of 2.63 years. • The pooled analysis from multiple clinical trials (n=255) demonstrated improvements in patient-reported symptoms, copper mobilization, and clinical assessments, with fewer than 5% of patients experiencing drug-related serious adverse events. • Patients reported higher convenience and effectiveness with ALXN1840 compared to standard of care, suggesting the drug candidate could provide meaningful benefits for the management of this rare genetic condition.

Monopar Therapeutics Advances Wilson Disease and Radiopharmaceutical Programs

Monopar Therapeutics in-licensed ALXN-1840 from Alexion for Wilson disease, planning regulatory discussions with the FDA focusing on patients with severe symptoms.

Monopar Acquires Late-Stage Wilson Disease Drug Candidate ALXN-1840 from Alexion, AstraZeneca Rare Disease

Monopar Therapeutics has acquired ALXN-1840, a late-stage drug candidate for Wilson disease, from Alexion, AstraZeneca Rare Disease, taking over global development and commercialization.

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