Drugs / TIOMOLIBDATE CHOLINE
TIOMOLIBDATE CHOLINE
also known as
ALXN1840 · ATN-224 · Bis-choline tetrathiomolybdate · formerly WTX101 · Choline tetrathiomolybdate · WTX-101
Small molecule targets SOD1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | Wilson disease | 2026-07-22 | “today announced that it has initiated the rolling submission of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for ALXN1840” monopartx.com ↗ “the rolling NDA submssion, that Monopar has initiated for ALXN1840” monopartx.com ↗ |
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 19 trials | ||||||
| Phase 1 | NCT04610580 | Jan → Mar 2021 | — | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04526210 | Oct 2020 → May 2021 | Wilson disease | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04560816 | Jul 2020 → Mar 2021 | — | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04526197 | Jul → Nov 2020 | Wilson disease | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04594252 | Jul → Nov 2020 | — | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05303324 | Jul → Oct 2019 | — | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05641311 | Feb → May 2019 | Wilson disease | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05319912 | Apr → May 2014 | — | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05319899 | Jan → Mar 2014 | — | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00352742 | Jun 2006 → Sep 2008 | plasma cell myeloma | Attenuon | Terminated | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT04422431 | Dec 2020 → May 2022 | Wilson disease | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT04573309 | Sep 2020 → Jun 2022 | Wilson disease | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02273596 | Nov 2014 → Oct 2016 | Wilson disease | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00674557 | Jun 2008 → Mar 2009 | breast cancer | Cancer Research UK | Terminated | No outcome recorded |
| Phase 2 | NCT00405574 | Nov 2006 → Jun 2008 | prostate cancer | Attenuon | Unknown | No outcome recorded |
| Phase 2 | NCT00383851 | Sep 2006 → Sep 2008 | melanoma | Attenuon | Unknown | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT05047523 | Sep 2021 → Jun 2023 | Wilson disease | Alexion Pharmaceuticals, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03403205 | Feb 2018 → Jun 2023 | Wilson disease | Alexion Pharmaceuticals, Inc. | Terminated | Met primary Stop: Business |
| Phase not stated1 trial | ||||||
| — | NCT05686564 | — | Wilson disease | Alexion Pharmaceuticals, Inc. | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-07-22 | Monopar Therapeutics | Regulatory Monopar Initiates Rolling NDA Submission for ALXN1840 in Wilson Disease monopartx.com ↗
Monopar has submitted the first completed sections of the NDA. |
| 2026-06-30 | Monopar Therapeutics | Regulatory Monopar Therapeutics Receives FDA Rare Pediatric Disease Designation for ALXN1840 for the Treatment of Wilson Disease monopartx.com ↗ |
| 2026-06-26 | Monopar Therapeutics | Results Monopar Presents New Analyses of Phase 3 FoCus Data at EAN 2026 Showing Greater Neurologic and Global Clinical Benefit with ALXN1840 Versus Standard of Care in Wilson Disease monopartx.com ↗
ALXN1840 also demonstrated similar or better outcomes compared to SoC across a range of psychiatric and hepatic measures during the 48-week study. |
| 2026-06-01 | Monopar Therapeutics | Results Monopar Presents Phase 2 ALXN1840 Data Demonstrating Liver Disease Stabilization and Neurologic Improvement in Treatment-Experienced Wilson Disease Patients at EASL 2026 monopartx.com ↗
ALXN1840 (tiomolibdate choline) Stabilizes Liver Disease and Improves Neurological Symptoms as well as Quality of Life in Treatment-Experienced Wilson Disease Patients |
| 2026-05-19 | Monopar Therapeutics | Results Monopar Announces Publication of Phase 2 Study Demonstrating ALXN1840 Significantly Improves Copper Balance in Patients with Wilson Disease monopartx.com ↗ |
| 2026-04-19 | Monopar Therapeutics | Results Monopar Presents Phase 3 Data Showing Greater Neurologic Benefit with ALXN1840 vs SoC in Wilson Disease Patients with Neurologic Symptoms at AAN 2026 monopartx.com ↗
Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, announced new analyses from the randomized controlled Phase 3 FoCus trial of ALXN1840 (tiomolibdate choline, TMC) showing greater neurologic benefit versus standard of care (SoC) in Wilson disease patients with neurologic symptoms at baseline. |
| 2025-11-09 | Monopar Therapeutics | Results Monopar Presents New Data and Analyses on Rapidly Improved Copper Balance in Wilson Disease Patients on Tiomolybdate Choline at AASLD - The Liver Meeting® 2025 monopartx.com ↗
The mean daily copper balance among patients treated with ALXN1840 in the study (n=8) was significantly lower - indicating improvement - compared with their pre-treatment baseline. |
| 2025-09-23 | Monopar Therapeutics | Results Monopar Announces Journal of Hepatology Publishes Physicians’ Letter to the Editor Demonstrating ALXN1840 Rapidly Improved Copper Balance in Wilson Disease Patients monopartx.com ↗
By controlling for the other routes of copper loss by comparing pre- and post-ALXN1840 treatment, the analysis demonstrates that ALXN1840 statistically significantly improved copper balance (increases copper excretion) over the duration of the study. |
| 2025-09-14 | Monopar Therapeutics | Results Monopar to Present New Long-Term Neurological Efficacy and Safety Data for ALXN1840 in Wilson Disease at the 150th American Neurological Association Annual Meeting monopartx.com ↗
The new data presented at ANA highlight the long-term neurological benefit of ALXN1840, and follow the recent presentation of long-term hepatic and systemic efficacy and safety data at the European Association for the Study of the Liver (EASL) International Liver Congress 2025. |
| 2025-05-07 | Monopar Therapeutics | Results Monopar Presents ALXN1840 Late-Breaker Data at EASL 2025 monopartx.com ↗
Sustained improvements from baseline in the Unified Wilson Disease Rating Scale (“UWDRS”) Part II (patient-reported symptoms) and Part III (clinician-assessed symptoms); |
| 2022-06-23 | AstraZeneca | Results ALXN1840 shows rapid and sustained improvement in copper mobilisation from tissues, potentially closing treatment gaps for Wilson disease community astrazeneca.com ↗
In the trial, people taking ALXN1840 experienced rapid copper mobilisation, with a response at four weeks and sustained through 48 weeks. |
| 2021-08-26 | AstraZeneca | Results ALXN1840 FoCus Phase III trial in Wilson disease met primary endpoint demonstrating improvement in copper mobilisation from tissues astrazeneca.com ↗
Positive high-level results from the FoCus Phase III trial in Wilson disease showed ALXN1840 met the primary endpoint with a statistically significant improvement in daily mean copper mobilisation from tissues, demonstrating superiority compared with standard-of-care (SoC) treatments. |
All press releases naming this drug 14 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TIOMOLIBDATE CHOLINE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594259 ↗ |
| Known as | ALXN1840 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05319899 ↗ |
| Known as | ATN-224 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00352742 ↗ |
| Known as | Bis-choline tetrathiomolybdate | “Bis-choline tetrathiomolybdate (WTX101) is an oral first-in-class copper-protein-binding molecule that targets hepatic intracellular copper and reduces plasma...” PMID 28988934 ↗ Oct 2017 |
| Known as | Choline tetrathiomolybdate | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594259 ↗ |
| Known as | formerly WTX101 | “formerly WTX101” NCT04594252 ↗1“formerly WTX101” NCT04573309 ↗ |
| Known as | WTX-101 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594259 ↗ |
| Action | Inhibit | “SOD1 inhibitor ATN-224” NCT00674557 ↗ |
| Modality | Small molecule | “ATN-224 is a small molecule that has been shown in pre-clinical studies to be antiangiogenic.” NCT00352742 ↗ |
| Route | Oral | “orally active” NCT00383851 ↗ |
| Target | SOD1 | “SOD1 inhibitor ATN-224” NCT00674557 ↗ |