Drugs / Leriglitazone
Leriglitazone
also known as
Min-102 · Hydroxypioglitazone · Hydroxypioglitazone hydrochloride · Leriglitazona · LERIGLITAZONE HYDROCHLORIDE · MIN-102 HCl
Small molecule targets PPARG via activation
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Refused (EMA) | EU (EMA) | Nezglyal | — | 2024-07-22 | europa.eu ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT04528706 | Sep 2019 → Dec 2023 | X-linked cerebral adrenoleukodystrophy | Minoryx Therapeutics, S.L. | Unknown | Met primary |
| Phase 2 | NCT03917225 | Mar 2019 → Aug 2020 | Friedreich ataxia | Minoryx Therapeutics, S.L. | Completed | Missed primary |
| Comparator or background therapy2 trials | ||||||
| Phase 2/3 | NCT03231878 Comparator | Dec 2017 → Jun 2021 | adrenoleukodystrophy | Minoryx Therapeutics, S.L. | Completed | No outcome recorded |
| Phase 3 | NCT05819866 Comparator | Jul 2023 → May 2027 expected | X-linked cerebral adrenoleukodystrophy | Minoryx Therapeutics, S.L. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 25
| Date | Issuer | Release |
|---|---|---|
| 2026-07-24 | Minoryx Therapeutics, S.L. | Regulatory NEZGLYAL® (leriglitazone) receives a positive CHMP opinion for the treatment of cerebral Adrenoleukodystrophy (cALD), a rare neurodegenerative disease minoryx.com ↗
The positive CHMP opinion is a regulatory validation, and we are very pleased that we will soon be able to provide a new therapeutic option to boys suffering from cALD. |
| 2025-07-23 | Minoryx Therapeutics, S.L. | Regulatory Leriglitazone Marketing Authorization Application submitted for treatment of cerebral adrenoleukodystrophy has been validated by European Medicines Agency minoryx.com ↗
EMA has now validated the MAA file and it is under review by the Committee for Medicinal Products for Human Use (CHMP). |
| 2025-06-05 | Minoryx Therapeutics, S.L. | Results Results from NEXUS interim analysis published in eClinicalMedicine, part of THE LANCET DiscoveryScience minoryx.com ↗ |
| 2024-12-11 | Minoryx Therapeutics, S.L. | Results Leriglitazone has met the primary endpoint in NEXUS, the pivotal trial for pediatric patients with cerebral Adrenoleukodystrophy minoryx.com ↗
All 20 patients remained clinically stable whilst on treatment and 7 out of 20 patients (35%) met the arrested disease criteria, which is significantly greater than the 10% self-arrested patients that would be expected from natural history (p<0.05). |
| 2024-06-11 | Minoryx Therapeutics, S.L. | Results Leriglitazone halts disease progression in adult patients with early cerebral adrenoleukodystrophy in compassionate-use study published in Brain minoryx.com ↗
Among the 13 patients treated with leriglitazone, the disease stabilized clinically and in radiological tests in 10 patients through up to two years of follow-up. |
| 2024-05-31 | Minoryx Therapeutics, S.L. | Regulatory Update on Regulatory Review of NEZGLYAL® (leriglitazone) in the EU minoryx.com ↗
the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended not to grant marketing authorization for NEZGLYAL® (leriglitazone) as a treatment for cALD following completion of the re-examination procedure. |
| 2024-01-26 | Minoryx Therapeutics, S.L. | Regulatory Update on Regulatory Review of leriglitazone in the EU minoryx.com ↗ |
| 2023-05-31 | Minoryx Therapeutics, S.L. | Regulatory Minoryx gains FDA approval to initiate a Phase 3 clinical trial in patients with cerebral Adrenoleukodystrophy minoryx.com ↗
The CALYX protocol has received both FDA and central IRB approval. |
| 2023-04-25 | Minoryx Therapeutics, S.L. | Results Minoryx presents positive interim results from NEXUS registration study for leriglitazone targeting pediatric ALD patients with cerebral adrenoleukodystrophy (cALD) minoryx.com ↗ |
| 2023-01-20 | Minoryx Therapeutics, S.L. | Results The Lancet Neurology publishes results from Minoryx Therapeutics Phase 2/3 ADVANCE clinical trial of leriglitazone in X-linked Adrenoleukodystrophy minoryx.com ↗
Leriglitazone was well tolerated, and significant benefit was shown through clinically meaningful myelopathy endpoints and reduced progression of cerebral lesions |
| 2022-11-29 | Minoryx Therapeutics, S.L. | Results Leriglitazone’s clinical proof of concept data in Friedreich’s Ataxia published in Neurology Genetics minoryx.com ↗
Although the primary endpoint was not met in this study, results from secondary endpoints provide evidence for clinical proof of concept for use of leriglitazone in patients with Friedreich’s Ataxia and support assessment in larger studies. |
| 2022-09-14 | Minoryx Therapeutics, S.L. | Regulatory Minoryx‘s Marketing Authorization Application for its lead candidate leriglitazone validated by EMA for orphan indication X-linked Adrenoleukodystrophy (X-ALD) minoryx.com ↗
The EMA has now validated the MAA file and it is under review by the Committee for Medicinal Products for Human Use (CHMP). |
| 2021-11-03 | Minoryx Therapeutics, S.L. | Results Additional data from Minoryx’s Phase 2/3 ADVANCE clinical trial presented at American Neurological Association (ANA) 2021 minoryx.com ↗
The results showed that Minoryx’s therapy leriglitazone reduces the progression of cerebral lesions and, based on plasma biomarkers, modulates neuroinflammation, preserves blood-brain barrier integrity and protects against axonal degeneration. |
| 2021-06-03 | Minoryx Therapeutics, S.L. | Results Minoryx publishes mechanism of action of leriglitazone in X-ALD in Science Translational Medicine journal minoryx.com ↗
Published results show efficacy in both adrenomyeloneuropathy (AMN) and cerebral ALD (cALD) related models. |
| 2021-04-12 | Minoryx Therapeutics, S.L. | Results Minoryx Phase 2/3 ‘ADVANCE’ study results to be presented at the 2021 American Neurological Association (AAN) Annual Meeting minoryx.com ↗
Overall results support the positive effects of leriglitazone on reducing the progression of cerebral lesions and myelopathy symptoms. |
| 2021-01-26 | Minoryx Therapeutics, S.L. | Results Minoryx presents topline results from Phase 2/3 “ADVANCE” study demonstrating significant clinical benefit of leriglitazone in adrenomyeloneuropathy (AMN) minoryx.com ↗
Minoryx Therapeutics, a Phase 3 clinical stage biotech company focused on the development of differentiating treatment options in orphan central nervous system (CNS) disorders, today announces topline results from its Phase 2/3 ADVANCE clinical trial. |
| 2020-12-15 | Minoryx Therapeutics, S.L. | Results Minoryx’s clinical candidate leriglitazone shows clinical benefit in a proof of concept Phase 2 study in Friedreich´s ataxia minoryx.com ↗
Treatment with leriglitazone resulted in PPARg engagement, within the target range, in all patients as assessed by the relevant biomarker (adiponectin). |
| 2020-11-16 | Minoryx Therapeutics, S.L. | Results Minoryx’s preclinical data for leriglitazone in Friedreich’s Ataxia published in Neurobiology of Disease Journal minoryx.com ↗
The results show that the company’s lead compound, leriglitazone, improves impairments that are derived from frataxin loss – the genetic deficiency that causes FRDA. |
| 2020-01-09 | Minoryx Therapeutics, S.L. | Regulatory Minoryx Therapeutics receives US FDA fast-track designation for leriglitazone in the treatment of X-ALD minoryx.com ↗
today announces that its lead drug candidate leriglitazone (MIN-102) has been granted fast track designation by the US Food and Drug Administration (FDA) |
| 2019-11-13 | Minoryx Therapeutics, S.L. | Regulatory Minoryx Therapeutics receives Orphan Drug Designation from the European Commission for leriglitazone in the treatment of Friedreich’s Ataxia minoryx.com ↗
Minoryx Therapeutics, a company that specializes in the development of innovative treatments for orphan Central Nervous System (CNS) diseases, today announces that its lead drug candidate, leriglitazone (MIN-102), has been granted Orphan Drug Designation by the European Commission in the treatment of Friedreich’s Ataxia. |
| 2019-10-17 | Minoryx Therapeutics, S.L. | Regulatory Minoryx Therapeutics receives FDA Orphan Drug Designation for leriglitazone in Friedreich’s Ataxia minoryx.com ↗
Minoryx Therapeutics, a company that specializes in the development of innovative treatments for orphan Central Nervous System (CNS) diseases, today announces that its lead drug candidate, leriglitazone (MIN-102), has been granted Orphan Drug Designation in Friedreich’s Ataxia by the US Food and Drug Administration (FDA). |
| 2019-02-27 | Minoryx Therapeutics, S.L. | Regulatory Minoryx Therapeutics receives approval from Spanish Regulatory Agency to initiate phase 2 study in Friedreich’s Ataxia minoryx.com ↗
Minoryx Therapeutics, a company specializing in the development of new drugs for orphan diseases, today announces that it has received approval from the Spanish Agency of Medicines and Medical Devices (AEMPS) to launch a phase 2 clinical trial in Friedreich’s Ataxia with its lead candidate, MIN-102 . |
| 2017-03-21 | Minoryx Therapeutics, S.L. | Results Minoryx Therapeutics successfully completes phase 1 clinical trial for lead candidate MIN-102 minoryx.com ↗
The results show that MIN-102 was generally safe and well tolerated at exposures exceeding the levels required for efficacy. |
| 2017-02-22 | Minoryx Therapeutics, S.L. | Regulatory Minoryx Therapeutics receives Orphan Drug Designation from the US FDA for its lead candidate MIN-102 minoryx.com ↗
Minoryx Therapeutics, a drug development company specialized in the discovery and development of new drugs for orphan diseases, today announces that its lead compound MIN-102 has been granted Orphan Drug Designation by the US Food and Drug Administration body (FDA). |
| 2016-12-14 | Minoryx Therapeutics, S.L. | Regulatory Minoryx Therapeutics receives European Orphan Drug Designation for its lead candidate MIN-102 minoryx.com ↗
Minoryx Therapeutics, a drug development company specialized in the discovery and development of new drugs for orphan diseases, today announces that its lead compound MIN-102 has been granted Orphan Drug Designation by the European Medicines Agency (EMA). |
All press releases naming this drug 37 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Leriglitazone | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05819866 ↗ |
| Known as | Hydroxypioglitazone | ChEMBL registry synonym — accepted as the source's own label CHEMBL1267 ↗ |
| Known as | Hydroxypioglitazone hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL1267 ↗ |
| Known as | Leriglitazona | ChEMBL registry synonym — accepted as the source's own label CHEMBL1267 ↗ |
| Known as | LERIGLITAZONE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL1267 ↗ |
| Known as | Min-102 | “Min-102 Oral suspension, strength 15mg/ml.” NCT04528706 ↗ |
| Known as | MIN-102 HCl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1267 ↗ |
| Action | Activate | “Peroxisome proliferator-activated receptor gamma agonist” CHEMBL1267 ↗ |
| Modality | Small molecule | — CHEMBL1267 ↗ |
| Route | Oral | “Min-102 Oral suspension, strength 15mg/ml.” NCT04528706 ↗ |
| Target | PPARG | “Peroxisome proliferator-activated receptor gamma agonist” CHEMBL1267 ↗ |