This section highlights FDA-related milestones and regulatory updates for drugs developed by Monopar Therapeutics (MNPR).
Over the past two years, Monopar Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ALXN1840-WD-204, MNPR-101-Zr, and MNPR-101-Lu. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
ALXN1840-WD-204 FDA Regulatory Events
ALXN1840-WD-204 is a drug developed by Monopar Therapeutics for the following indication: Liver Diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ALXN1840-WD-204
- Announced Date:
- November 9, 2025
- Indication:
- Liver Diseases
Announcement
Monopar Therapeutics Inc. is presenting new data and analyses today from the Phase 2 ALXN1840-WD-204 copper balance study at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2025, taking place in Washington, D.C., from November 7-11, 2025.
AI Summary
Monopar Therapeutics is presenting new Phase 2 data today from the ALXN1840‑WD‑204 copper balance study at AASLD — The Liver Meeting® 2025 in Washington, D.C. (Nov. 7–11). In an oral presentation titled "Rapidly Improved Cu Balance in Wilson Disease Patients on Tiomolybdate Choline," Professor Aftab Ala reported that ALXN1840 (tiomolybdate choline) produced a rapid, sustained improvement in daily copper balance, primarily by increasing fecal copper excretion, suggesting the drug helps remove excess copper from the body.
In the study (n=8), mean daily copper balance on ALXN1840 was significantly lower than each patient’s pre‑treatment baseline. Improvement was seen during the initial 15 mg once‑daily period (days 1–28) and was maintained across days 1–39, which included dosing of 15 mg every other day or 30 mg once daily. Additional supporting nonclinical and clinical analyses will be presented; materials and the abstract are available on Monopar’s and AASLD’s websites.
Read Announcement- Drug:
- ALXN1840-WD-204
- Announced Date:
- October 15, 2025
- Indication:
- Liver Diseases
Announcement
Monopar Therapeutics Inc announced that its abstract on the Phase 2 ALXN1840-WD-204 copper balance study has been selected for an oral presentation at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2025, taking place in Washington, D.C., from November 7-11, 2025..
AI Summary
Monopar Therapeutics Inc. announced that its abstract on the Phase 2 ALXN1840-WD-204 copper balance study has been selected for an oral presentation at the American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2025 in Washington, D.C., November 7–11, 2025.
The study examines how tiomolybdate choline rapidly improves copper balance in patients with Wilson disease. The presentation, titled “Rapidly Improved Cu Balance in Wilson Disease Patients on Tiomolybdate Choline” (Publication Number: 0073), will be delivered by Aftab Ala, MBBS, M.D., FRCP, Ph.D., on Sunday, November 9, from 9:00 to 9:15 am EST during the “Distinct Pathways, Shared Progress: Metabolic/Genetic Disorders & Biliary Physiology” session.
The abstract is available now on the AASLD conference website. Detailed presentation materials will also be posted at www.monopartx.com on November 9, 2025, highlighting Monopar’s advancing efforts to develop ALXN1840 as a treatment for Wilson disease.
Read Announcement
MNPR-101-Zr FDA Regulatory Events
MNPR-101-Zr is a drug developed by Monopar Therapeutics for the following indication: In Advanced Cancer Patients.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MNPR-101-Zr
- Announced Date:
- June 11, 2025
- Indication:
- In Advanced Cancer Patients
Announcement
Monopar Therapeutics Inc. announced that the physician-sponsored Expanded Access Program ("EAP") for the investigational imaging agent MNPR-101-Zr and investigational therapeutic agent MNPR-101-Lu has received authorization to proceed from the U.S. Food and Drug Administration ("FDA").
AI Summary
Monopar Therapeutics Inc. announced that it has received FDA approval to proceed with its physician-sponsored Expanded Access Program (EAP) for the investigational products MNPR-101-Zr and MNPR-101-Lu. These agents are designed to help image and treat advanced solid tumors, including aggressive forms of cancer like triple-negative breast, pancreatic, and colorectal cancers. The study will be conducted at the Excel Diagnostics and Nuclear Oncology Center (EDNOC) in Houston, Texas, where patients with advanced solid tumors can now enroll under the EAP.
The program offers a way for patients with serious or life-threatening conditions to access these new treatments outside of clinical trials when no other options are available. The initiative is led by expert Dr. Ebrahim S. Delpassand, aiming to advance the use of targeted radiopharmaceuticals in cancer care while closely monitoring safety and effectiveness as the therapy moves towards wider use.
Read Announcement- Drug:
- MNPR-101-Zr
- Announced Date:
- September 12, 2024
- Indication:
- In Advanced Cancer Patients
Announcement
Monopar Therapeutics Inc. announced positive early data from its ongoing open-label MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial confirming MNPR-101-Zr's tumor targeting ability in humans.
AI Summary
Monopar Therapeutics announced encouraging results from its MNPR-101-Zr Phase 1 imaging and dosimetry trial, confirming the drug’s ability to target tumors in humans. MNPR-101-Zr pairs a specialized humanized monoclonal antibody with a radioactive zirconium label to seek out cancer cells. In one patient, PET imaging taken seven days after treatment clearly showed that MNPR-101-Zr was concentrated in tumor areas, distinguishing them from normal tissue.
These findings support the promise of MNPR-101-Zr as a reliable imaging tool for cancers that express high levels of specific receptors. The targeted uptake observed in this early study could lead to better cancer detection and, ultimately, more effective treatments in the future.
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MNPR-101-Lu FDA Regulatory Events
MNPR-101-Lu is a drug developed by Monopar Therapeutics for the following indication: In Advanced Cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MNPR-101-Lu
- Announced Date:
- October 7, 2024
- Indication:
- In Advanced Cancers
Announcement
Monopar Therapeutics Inc. announced that the Phase 1a clinical trial for its novel therapeutic radiopharmaceutical MNPR-101-Lu (MNPR-101 conjugated to lutetium-177) is now active and recruiting patients with advanced cancers.
AI Summary
Monopar Therapeutics Inc. announced that its Phase 1a clinical trial for the new radiopharmaceutical MNPR-101-Lu is now active and recruiting patients with advanced cancers. This trial, which focuses on evaluating the safety and appropriate dosing of MNPR-101-Lu in patients with solid tumors, marks a significant step forward in the company’s efforts to create targeted cancer treatments.
The study is an open-label, dose-escalation trial and is being conducted at the Melbourne Theranostic Innovation Centre in Australia. Patients eligible for this trial are also enrolled in an ongoing MNPR-101-Zr trial, ensuring that those most likely to benefit are selected. MNPR-101-Lu is designed to deliver lutetium-177 to tumors by targeting the urokinase plasminogen activator receptor (uPAR), which is commonly found in various types of cancer.
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