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Minzasolmin
Last update 07 Jun 2025
Overview
Basic Info
Drug Type Small molecule drug |
Synonyms DLX 313, DLX-313, DLX313 + [3] |
Target |
Action inhibitors |
Mechanism α-synuclein inhibitors(Synuclein alpha inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization |
Drug Highest PhasePhase 2 |
First Approval Date- |
Regulation- |
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Structure/Sequence
Molecular FormulaC23H31N5OS |
InChIKeyGDFWCSZNQVAQGR-GOSISDBHSA-N |
CAS Registry1802518-92-8 |
Related
7
Clinical Trials associated with MinzasolminNCT06533475
An Open-Label, Randomized Study to Evaluate the Relative Bioavailability of a New Tablet Formulation of Minzasolmin and the Potential Effect of Food on the Pharmacokinetics of Minzasolmin in Healthy Participants
The purpose of the study is to estimate the relative bioavailability of a new minzasolmin tablet formulation versus reference 'granules in capsule' formulation in healthy participants and to evaluate the effect of food with the new tablet formulation on the pharmacokinetics (PK) of minzasolmin.
Start Date06 Sep 2024 |
Sponsor / Collaborator |
CTIS2023-507959-29-00
- CDLX313A12101
Start Date22 Jul 2024 |
Sponsor / Collaborator |
NCT05845645
A 2-Part Study to Evaluate the Relative Bioavailability of 2 New Formulations of UCB0599 and the Effect of Esomeprazole on the PK of UCB0599 in Healthy Participants (Part A, Open-Label) and to Assess the Safety/Tolerability and PK of UCB0599 in Healthy Participants of Japanese and Chinese Origins (Part B, Double-Blind)
The purpose of the study is to estimate the relative bioavailability of 2 new UCB0599 formulations under elevated and normal gastric pH conditions in healthy participants (Part A) and to asess the safety, tolerability and pharmacokinetics of UCB0599 in healthy participants of Japanese and Chinese origins (Part B).
Start Date31 May 2023 |
Sponsor / Collaborator |
100 Clinical Results associated with Minzasolmin
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100 Translational Medicine associated with Minzasolmin
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100 Patents (Medical) associated with Minzasolmin
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7
Literatures (Medical) associated with Minzasolmin01 Apr 2024·Molecular imaging and biology
Evaluation and Application of a PET Tracer in Preclinical and Phase 1 Studies to Determine the Brain Biodistribution of Minzasolmin (UCB0599)
Article
Author: Huiban, Mickael ; Mercier, Joël ; van Asch, Vanja ; Plisson, Christophe ; Searle, Graham ; Maguire, Ralph Paul ; Smit, Johan Willem ; Wagneur, Michel ; Otoul, Christian ; Nicholl, Richard ; Germani, Massimiliano ; Lalla, Marianna ; Bani, Massimo ; Colson, Anny-Odile ; Mathy, François-Xavier
Abstract:
Purpose:
Minzasolmin (UCB0599) is an orally administered, small molecule inhibitor of ASYN misfolding in development as a potential disease-modifying therapy for Parkinson’s disease. Here we describe the preclinical development of a radiolabeled tracer and results from a phase 1 study using the tracer to investigate the brain distribution of minzasolmin.
Procedures:
In the preclinical study, two radiolabeling positions were investigated on the S-enantiomer of minzasolmin (UCB2713): [11C]methylamine UCB2713 ([11C-N-CH3]UCB2713) and [11C]carbonyl UCB2713 ([11C-CO]UCB2713). Male C57 black 6 mice (N = 10) received intravenous [11C-N-CH3]UCB2713; brain homogenates were assessed for radioactivity and plasma samples analyzed by high-performance liquid chromatography. Positron emission tomography-computed tomography (PET-CT) was used to image brains in a subset of mice (n = 3). In the open-label, phase 1 study, healthy volunteers were scanned twice with PET-CT following injection with [11C]minzasolmin radiotracer (≤ 10 µg), first without, then with oral dosing with non-radiolabeled minzasolmin 360 mg. Primary objective: to determine biodistribution of minzasolmin in the human brain; secondary objectives included minzasolmin safety/tolerability.
Results:
Preclinical data supported the use of [11C]minzasolmin in clinical studies. In the phase 1 study, PET data showed substantial drug signal in the brain of healthy volunteers (N = 4). The mean estimated whole brain total distribution volume (VT) at equilibrium across all regions of interest was 0.512 mL/cm3, no difference in VT was observed following administration of minzasolmin 360 mg. Treatment-emergent adverse events (TEAEs) were reported by 75% (n = 3) of participants. No drug-related TEAEs, deaths, serious adverse events, or discontinuations were reported.
Conclusion:
Following positive preclinical results with the N-methyl labeled PET tracer, [11C]minzasolmin was used in the phase 1 study, which demonstrated that minzasolmin readily crossed the blood–brain barrier and was well distributed throughout the brain. Safety and pharmacokinetic findings were consistent with previous early-phase studies (such as UP0077, NCT04875962).
11 Apr 2023·Proceedings of the National Academy of Sciences of the United States of AmericaQ1 · CROSS-FIELD
High-resolution structural information of membrane-bound α-synuclein provides insight into the MoA of the anti-Parkinson drug UCB0599.
Q1 · CROSS-FIELD
Article
Author: Hoefurthner, Theresa ; Schwarz, Thomas C. ; Beier, Andreas ; Hartl, Markus ; Ledolter, Karin ; Konrat, Robert ; Baker, Terry S. ; Gossenreiter, Thomas ; Taylor, Richard J.
α-synuclein (αS) is an intrinsically disordered protein whose functional ambivalence and protein structural plasticity are iconic. Coordinated protein recruitment ensures proper vesicle dynamics at the synaptic cleft, while deregulated oligomerization on cellular membranes contributes to cell damage and Parkinson's disease (PD). Despite the protein's pathophysiological relevance, structural knowledge is limited. Here, we employ NMR spectroscopy and chemical cross-link mass spectrometry on 14N/15N-labeled αS mixtures to provide for the first time high-resolution structural information of the membrane-bound oligomeric state of αS and demonstrate that in this state, αS samples a surprisingly small conformational space. Interestingly, the study locates familial Parkinson's disease mutants at the interface between individual αS monomers and reveals different oligomerization processes depending on whether oligomerization occurs on the same membrane surface (cis) or between αS initially attached to different membrane particles (trans). The explanatory power of the obtained high-resolution structural model is used to help determine the mode-of-actionof UCB0599. Here, it is shown that the ligand changes the ensemble of membrane-bound structures, which helps to explain the success this compound, currently being tested in Parkinson's disease patients in a phase 2 trial, has had in animal models of PD.
01 Oct 2022·Movement disorders : official journal of the Movement Disorder Society
Phase 1/1b Studies of UCB0599 , an Oral Inhibitor of α‐Synuclein Misfolding, Including a Randomized Study in Parkinson's Disease
Article
Author: Smit, Johan Willem ; Bani, Massimo ; Basile, Peter ; Schmidt, Astrid ; Mathy, François‐Xavier ; Germani, Massimiliano ; Prato, Maria Key ; Detalle, Laurent ; Genius, Just ; Biere, Anja‐Leona ; Lalla, Marianna ; Carson, Stan ; Domange, Coralie
Abstract:
Background:
Parkinson's disease (PD) and its progression are thought to be caused and driven by misfolding of α‐synuclein (ASYN). UCB0599 is an oral, small‐molecule inhibitor of ASYN misfolding, aimed at slowing disease progression.
Objective:
The aim was to investigate safety/tolerability and pharmacokinetics (PK) of single and multiple doses of UCB0599.
Methods:
Safety/tolerability and PK of single and multiple doses of UCB0599 and its metabolites were investigated in two phase 1 studies in healthy participants (HPs), where food effect and possible interaction with itraconazole (ITZ) were assessed (UP0030 [randomized, placebo‐controlled, dose‐escalation, crossover study, N = 65] and UP0078 [open‐label study, N = 22]). Safety/tolerability and multi‐dose PK of UCB0599 were subsequently investigated in a phase 1b randomized, double‐blind, placebo‐controlled study of participants with PD (UP0077 [NCT04875962], N = 31).
Results:
Across all studies, UCB0599 displayed rapid absorption with linear, time‐independent PK properties; PK of multiple doses of UCB0599 were predictable from single‐dose exposures. No notable food‐effect was observed; co‐administration with ITZ affected UCB0599 disposition (maximum plasma concentration and area under the curve increased ~1.3‐ and ~2 to 3‐fold, respectively) however, this did not impact the safety profile. Hypersensitivity reactions were reported in UP0030 (n = 2) and UP0077 (n = 2). Treatment‐related adverse events occurred in 43% (UCB0599), and 30% (placebo) of participants with PD were predominantly mild‐to‐moderate in intensity and were not dose related.
Conclusions:
Seventy‐three HPs and 21 participants with PD received UCB0599 doses; an acceptable safety/tolerability profile and predictable PK support continued development of UCB0599 for the slowing of PD progression. A phase 2 study in early‐stage PD is underway (NCT04658186). © 2022 UCB Pharma. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.
10
News (Medical) associated with Minzasolmin22 Apr 2025
As a selective monoamine oxidase B (MAO-B) inhibitor, XADAGO offers a unique mechanism of action that complements traditional therapies, potentially improving motor function and reducing "off" time in patients. The increasing prevalence of Parkinson's disease and the growing demand for effective therapies create a substantial market opportunity for XADAGO, particularly in regions with aging populations.
LAS VEGAS, April 22, 2025 /PRNewswire/ -- DelveInsight's "
XADAGO/EQUFINA Market Size, Forecast, and Market Insight Report" highlights the details around XADAGO/EQUFINA, an inhibitor of monoamine oxidase B (MAO-B) indicated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing "off" episodes. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of XADAGO/EQUFINA. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Newron Pharmaceuticals/Eisai/Meiji Seika Pharma's XADAGO/EQUFINA (safinamide) Overview
XADAGO is a monoamine oxidase B (MAO-B) inhibitor used alongside levodopa/carbidopa to help manage "off" episodes in individuals with Parkinson's disease. While its exact mode of action in treating Parkinson's is not fully understood, it is thought to work by inhibiting MAO-B, thereby reducing dopamine breakdown. This leads to increased dopamine levels and enhanced dopaminergic activity in the brain. XADAGO contains the active ingredient safinamide in the form of a mesylate salt and is available in 50 mg and 100 mg film-coated oral tablets. Each tablet provides either 65.88 mg or 131.76 mg of safinamide mesylate, equivalent to 50 mg or 100 mg of the safinamide base. The medication is marketed as XADAGO in the United States and Europe and under the name EQUFINA in Japan.
Learn more about XADAGO/EQUFINA projected market size for Parkinson's disease @
XADAGO/EQUFINA Market Potential
Parkinson's disease is a progressive neurological disorder that mainly impairs movement control. It results from the slow degeneration of dopamine-producing neurons in the brain, especially in the substantia nigra, a region crucial for managing voluntary motor function. According to estimates by DelveInsight, there were
2.7 million diagnosed prevalent cases of Parkinson's disease in the 7MM in 2023, with the United States accounting for around
45% of these cases. While a cure for Parkinson's remains elusive, a combination of pharmacological and non-pharmacological therapies is used to manage symptoms. Physical, occupational, and speech therapies form key components of treatment, and surgical procedures may benefit select patients. Additionally, complementary therapies are sometimes employed to help address particular symptoms.
Frequently prescribed medications for Parkinson's include
levodopa, dopamine agonists, MAO-B inhibitors, COMT inhibitors, amantadine, anticholinergics, and adenosine A2A antagonists. These treatments primarily target motor symptoms, which are a major concern for those affected. DelveInsight reports that the Parkinson's disease market in the 7MM was valued at
USD 3.2 billion in 2023. The market is expected to grow over the forecast period (2020–2034), fueled by the launch of new therapies, increasing prevalence, better access to healthcare, and rising demand for more advanced and effective treatment options.
Discover more about the Parkinson's disease market in detail @
Parkinson's Disease Market Report
Emerging Competitors of XADAGO/EQUFINA
Some of the drugs in the pipeline include
Solengepras (Cerevance),
Minzasolmin (UCB Biopharma SRL/Novartis),
Buntanetap (Annovis Bio), and others.
Buntanetap has successfully completed Phase III trials for early-stage Parkinson's disease. Annovis Bio has scheduled a meeting with the FDA in Q1 2025 to determine the development path forward for Buntanetap in the treatment of Parkinson's disease. Buntanetap is also being developed for Alzheimer's disease, Lewy Body Dementia, and other neurodegenerative disorders.
In
November 2024, Cerevance announced the dosing of the first patient in its pivotal Phase III ARISE trial, evaluating solengepras as a potential adjunctive treatment for Parkinson's disease. Cerevance expects to report topline data in the first half of 2026. In
December 2021, UCB partnered with
Novartis to globally co-develop and co-commercialize
UCB0599, a pioneering alpha-synuclein misfolding inhibitor currently in Phase II clinical trials for Parkinson's disease.
To know more about the number of competing drugs in development, visit @
XADAGO/EQUFINA Market Positioning Compared to Other Drugs
Key Milestones of XADAGO/EQUFINA
In
April 2020, Newron Pharmaceutical acknowledged that US WorldMeds, who held the US commercialization rights for the licensed drug, XADAGO, as a sub licensee of Zambon, had entered into a definitive agreement with Supernus Pharmaceuticals under which Supernus would acquire the CNS portfolio of US WorldMeds, including the US rights to XADAGO
In
November 2019, Eisai announced that it had launched the EQUFINA 50mg tablets for the indication of improvement of the wearing-off phenomenon in patients with Parkinson's disease under treatment with a drug containing levodopa in Japan. Manufacturing and marketing approval of EQUFINA was obtained in September 2019.
In
April 2017, Eisai Co., Ltd. and Meiji Seika Pharma announced entering into a license agreement for the commercialization of safinamide (development code: ME2125) to treat Parkinson's disease in Japan and Asia.
In
March 2017, Newron Pharmaceuticals announced the US FDA approval of XADAGO to treat Parkinson's disease as an add-on therapy to levodopa/carbidopa for patients experiencing "off" episodes.
In
March 2016, Zambon announced a strategic agreement with US WorldMeds to commercialize Newron's lead compound, XADAGO, to treat Parkinson's disease in the US.
In
February 2015, XADAGO was approved in the European Union as an add-on therapy to levodopa, alone or in combination with other Parkinson's medications, in mid-late stage PD patients with motor fluctuations.
XADAGO/EQUFINA Patent Details
XADAGO tablets are currently protected by three XADAGO patents with US patent numbers 8,076,515, 8,278,485, and 8,283,380, which expire between June 2027 and December 2028 and are listed in the FDA's publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book. The company has a license agreement with Zambon S.p.A., Newron's partner, related to the XADAGO Patents, and as a new chemical entity, XADAGO is under the 5-year FDA exclusivity period that expires on March 21, 2022.
In May 2017, Zambon filed a worldwide patent under the patent number WO2017207587A1. The invention relates to pharmaceutical compositions comprising safinamide and, more particularly, to taste-masked particles comprising said active ingredient or pharmaceutically acceptable salts thereof, oral dosage forms that include said particles, and a process for preparing them.
Discover how XADAGO/EQUFINA is shaping the Parkinson's disease treatment landscape @
XADAGO 50mg
XADAGO/EQUFINA Market Dynamics
XADAGO, marketed as EQUFINA in some regions (notably in South Korea and Japan), is a once-daily oral selective
MAO-B inhibitor used as an add-on treatment for Parkinson's disease patients experiencing "off" episodes while on a stable dose of levodopa. The drug's unique dual mechanism of action—MAO-B inhibition and modulation of glutamate release—offers both
dopaminergic and non-dopaminergic effects, positioning it as a differentiated product in the PD adjunctive therapy landscape. This has helped it carve a niche in markets where patients are inadequately controlled by levodopa alone, particularly those in mid-to-late-stage PD.
The global market dynamics for XADAGO/EQUFINA are shaped by a mix of
competitive intensity, regional adoption trends, and payer dynamics. In the U.S. and Europe, the drug has faced stiff competition from
generic MAO-B inhibitors (like
selegiline and rasagiline) and newer Parkinson's disease therapies, including
COMT inhibitors, dopamine agonists, and extended-release levodopa formulations. Despite this, its favorable safety profile and once-daily dosing have supported its uptake in certain patient segments, especially in Europe. Market penetration has been slower in the U.S. due to both
reimbursement hurdles and physician preference for more established adjunctive treatments.
In Asia, particularly
Japan and South Korea, EQUFINA has demonstrated stronger market performance thanks to
focused commercial strategies and a
high unmet need for effective "off time" management.
Meiji Seika Pharma and Eisai, the regional marketing partners, have successfully leveraged the drug's differentiated profile in clinician education, which has led to
growing adoption among neurologists. In Japan, where the
aging population is rapidly expanding and
Parkinson's prevalence is rising, EQUFINA has benefited from both demographic tailwinds and formulary access.
Looking ahead, the market outlook for XADAGO/EQUFINA depends on several strategic levers, including
lifecycle management, regional partnerships, and real-world evidence generation. The manufacturer's ability to expand into new geographies, secure favorable reimbursement, and differentiate against both generics and newer entrants will be critical. Moreover, as Parkinson's disease treatment moves toward more personalized approaches, XADAGO/EQUFINA may find sustained relevance in specific subpopulations, particularly those requiring a balance of efficacy and tolerability.
Dive deeper to get more insight into XADAGO/EQUFINA's strengths & weaknesses relative to competitors @
XADAGO/EQUFINA Market Drug Report
Table of Contents
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Phase 3Drug ApprovalLicense out/inPhase 2
30 Jan 2025
iStock,
Afry Harvy
Inhibikase’s setback continues biopharma’s losing streak against Parkinson’s, marked by several clinical failures and abandoned assets in recent months.
Inhibikase Therapeutics on Wednesday announced that it will
suspend the further development
of its investigational drug risvodetinib in Parkinson’s disease.
The decision was spurred by underwhelming findings from a Phase II trial, which the biotech in an SEC filing said met its primary efficacy endpoint of safety and tolerability but failed to demonstrate significant efficacy. Inhibikase provided limited data in its regulatory document, but promised to present a more complete readout and analysis at a future medical congress.
In a hierarchy of 15 functional endpoints, risvodetinib failed to elicit a significant improvement in the top measure, which was the sum of scores in parts 2 and 3 of the Movement Disorder Society Universal Parkinson’s Disease Rating Scale (MDS-UPDRS).
Still, Ironwood flagged certain promising signals of efficacy. Patients treated with 100 mg risvodetinib saw a 1.41-point improvement in part 2 of the MDS-UPDRS, an effect with a nominal p-value of 0.036, according to the biotech. Meanwhile, the 50-mg dose led to a 4% increase in the results of the Schwab & England Activities of Daily Life Scale, a treatment effect with a nominal p-value of 0.0004.
With risvodetinib paused, Inhibikase is switching its focus to its new lead program IkT-001Pro, which it is developing for pulmonary arterial hypertension. The biotech will look at potential strategic options for risvodetinib but has yet to specify possibilities such as licensing deals or a sale. Aside from Parkinson’s, Inhibikase
was also trialing
risvodetinib for neurogenic constipation, dysphagia and multiple system atrophy.
Inhibikase’s stock price declined more than 19% in after-hours trading at $2.26 per share, down from $2.80 at the previous close.
Risvodetinib’s discontinuation highlights the difficulties of developing effective therapies for Parkinson’s disease, a therapeutic space that has suffered several stumbles and even more
abandoned assets
in recent months.
Last month, for instance, Roche disclosed that its Prothena-allied prasinezumab
failed
a Phase IIb Parkinson’s study, unable to significantly slow motor progression in patients. Just days earlier, Novartis and UCB announced that their drug candidate minzasolmin likewise
failed
a proof-of-concept Parkinson’s study.
Fellow Big Pharma Johnson & Johnson has also struggled with Parkinson’s, revealing in October 2024 that it would
no longer invest
in JNJ-0376, an early-stage drug candidate that, according to an
earlier business presentation
, had “novel mechanisms to modify, treat and/or prevent neurodegenerative disorders.”
In April of the same year, Sage Therapeutics was also
forced to turn its back
on its Parkinson’s program for the oral asset dalzanemdor after a mid-stage study found no significant cognitive improvements in treated adult patients.
Phase 2Clinical ResultClinical Trial Failure
19 Dec 2024
Roche’s alpha-synuclein-targeting antibody has failed to slow the progression of motor symptoms in a mid-stage Parkinson’s disease test, marking the latest setback in a largely challenging year for the disease pipeline.
The pharma company’s prasinezumab missed statistical significance in the Phase 2b PADOVA study’s primary endpoint of time to confirmed motor progression versus placebo (p=0.0657), according to a Thursday
release
. The trial enrolled 586 people with early-stage Parkinson’s who were taking stable doses of levodopa or a monoamine oxidase-B inhibitor.
Roche secured the rights to prasinezumab more than ten years ago, when it inked a global development and commercialization
deal
with the drug’s creator, Prothena, worth up to $600 million. Prothena’s share price
$PRTA
was down around 6% premarket Thursday.
Prasinezumab seemed to have a stronger effect in the subset of Phase 2b patients taking levodopa, Roche said. There were also “positive trends” in multiple secondary endpoints.
Roche plans to present the full Phase 2b data at a future medical meeting. In the meantime, the Swiss drugmaker will carry on with open-label extensions of PADOVA and a separate failed prasinezumab study called PASADENA. The latter trial
missed its primary endpoint
in 2020.
Roche is not the only company to struggle with developing effective treatments for Parkinson’s. On Tuesday, UCB and Novartis reported that minzasolmin, which has the same mechanism as prasinezumab, failed to significantly slow signs of
disease progression
in a Phase 2a study. In April, Sage Therapeutics
axed its Parkinson’s asset
, dalzanemdor, on the heels of a Phase 2 disappointment. Two months later, the FDA
rejected
AbbVie’s 24-hour infusion therapy for Parkinson’s for the second time due to manufacturing concerns.
AbbVie has had better luck with tavapadon, the Parkinson’s drug it acquired from Cerevel, which passed its
third late-stage test
earlier this month.
Phase 2Clinical Trial FailurePhase 3Acquisition
100 Deals associated with Minzasolmin
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R&D Status
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Parkinson Disease | Phase 2 | United States | 30 Dec 2020 | |
| Parkinson Disease | Phase 2 | Canada | 30 Dec 2020 | |
| Parkinson Disease | Phase 2 | France | 30 Dec 2020 | |
| Parkinson Disease | Phase 2 | Germany | 30 Dec 2020 | |
| Parkinson Disease | Phase 2 | Italy | 30 Dec 2020 | |
| Parkinson Disease | Phase 2 | Netherlands | 30 Dec 2020 | |
| Parkinson Disease | Phase 2 | Poland | 30 Dec 2020 | |
| Parkinson Disease | Phase 2 | Spain | 30 Dec 2020 | |
| Parkinson Disease | Phase 2 | United Kingdom | 30 Dec 2020 | |
| Parkinson Disease, Secondary | Phase 1 | United States | 06 May 2019 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
| Study | Phase | Population | Analyzed Enrollment | Group | Results | Evaluation | Publication Date |
|---|
Phase 2 | 450 | enpkevkgpt(ngzrkgvnfn) = not meet primary clinical endpoints. aaforkykhu (cdslsmncdp ) Not Met View more | Negative | 16 Dec 2024 | |||
Placebo | |||||||
Phase 1 | ASYN misfolding | 4 | Minzasolmin (UCB0599) | wrabwyorwr(dryjwtnukw) = Treatment-emergent adverse events (TEAEs) were reported by 75% (n = 3) of participants. No drug-related TEAEs, deaths, serious adverse events, or discontinuations were reported. ttkdwqqszz (uqamyvqlle ) | Positive | 01 Apr 2024 |
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