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Last update 17 Aug 2026

Rasagiline mesylate

Last update 17 Aug 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Agilect, Elbrus, rasagiline

+ [18]

Target

MAO-B

Action

inhibitors

Mechanism

MAO-B inhibitors(Monoamine oxidase B inhibitors)

Therapeutic Areas

Nervous System DiseasesEndocrinology and Metabolic Disease

Active Indication

Parkinson DiseasePrimary Parkinson's disease

Inactive Indication

Dementia due to Alzheimer's disease (disorder)Motor DisordersMultiple System Atrophy+ [2]

Originator Organization

Teva Pharmaceutical Industries Ltd.

Technion-Israel Institute of Technology

Active Organization

Teva Pharmaceuticals Australia Pty Ltd

Shanghai Shangyao Chinese-Western Pharmaceutical Co., LtdTeva Pharmaceuticals Europe BV

+ [7]

Inactive Organization

H. Lundbeck A/STeva Neuroscience, Inc.

Eisai, Inc.

+ [1]

License Organization

Teva Pharmaceutical Industries Ltd.

Takeda Pharmaceutical Co., Ltd.

Eisai Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

European Union (21 Feb 2005),

Parkinson Disease

RegulationPriority Review (China)

Structure/Sequence

Molecular FormulaC13H17NO3S

InChIKeyJDBJJCWRXSVHOQ-UTONKHPSSA-N

CAS Registry161735-79-1

Clinical Trials associated with Rasagiline mesylate

TCTR20251022003

/ Not yet recruitingPhase 1/2

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Rasagiline 1 mg Tablets of Remedica Ltd., Cyprus and Reference Product MAH (Azilect) in Healthy Adult Thai Volunteers under Fasting Conditions

Start Date03 Mar 2026

Sponsor / Collaborator-

TCTR20250825002

/ Not yet recruitingPhase 1IIT

A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Rasagiline Tablets 1 mg relative to AZILECT 1 mg tablets in healthy Thai volunteers under fasting condition

Start Date19 Feb 2026

Sponsor / Collaborator

Bio-innova Co., Ltd

CTR20260001

/ CompletedNot Applicable

甲磺酸雷沙吉兰片在健康受试者中空腹条件下开放、随机、单次给药、两制剂、两序列、四周期完全重复交叉设计生物等效性试验

[Translation] A bioequivalence study of rasagiline mesylate tablets in healthy subjects under fasting conditions, using an open-label, randomized, single-dose, two-formulation, two-sequence, four-period fully replicate crossover design.

本试验旨在研究单次空腹口服武汉人福药业有限责任公司研制、生产的甲磺酸雷沙吉兰片（1 mg）的药代动力学特征；以Teva Pharmaceutical Industries Ltd.持证、生产的甲磺酸雷沙吉兰片（安齐来®，1 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

[Translation]

This study aimed to investigate the pharmacokinetic characteristics of rasagiline mesylate tablets (1 mg) developed and manufactured by Wuhan Renfu Pharmaceutical Co., Ltd. via a single fasting oral administration. Rasagiline mesylate tablets (Anzilai®, 1 mg) manufactured by Teva Pharmaceutical Industries Ltd. were used as the reference formulation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two formulations were compared to evaluate their bioequivalence in humans.

Start Date23 Jan 2026

Sponsor / Collaborator

Wuhan Humanwell Pharmaceutical Co., Ltd.

100 Clinical Results associated with Rasagiline mesylate

100 Translational Medicine associated with Rasagiline mesylate

100 Patents (Medical) associated with Rasagiline mesylate

833

Literatures (Medical) associated with Rasagiline mesylate

31 Dec 2026·JOURNAL OF ENZYME INHIBITION AND MEDICINAL CHEMISTRY

Discovery of novel N-(prop-2-yn-1-yl)-1,2,3,4-tetrahydronaphthalen-1-amine derivatives as MAO-B inhibitors for the treatment of Parkinson’s disease

Article

Author: Wang, Ziwei ; Zhang, Wanping ; Yi, Chengwan ; Yu, Yu ; Fu, Xianwu ; Feng, Jing

Monoamine oxidase B (MAO-B) inhibitors may be an effective therapeutic approach for Parkinson's disease. This study designed and synthesised a series of N-(prop-2-yn-1-yl)-1,2,3,4-tetrahydronaphthalen-1-amine derivatives and evaluated their inhibitory activity against human MAO-B (hMAO-B). Most compounds exhibited inhibitory activity and selectivity, with compounds 29 and 34 demonstrating the strongest inhibitory potency (IC₅₀ = 0.066 ± 0.03 μM and 0.070 ± 0.002 μM, respectively) and selectivity indices (SI > 151 and 134), which were superior to the positive control rasagiline. Enzyme kinetic studies confirmed that these representative active compounds exhibited mixed reversible inhibition of hMAO-B. Molecular docking and kinetic analyses indicated that compound 29 binds stably to the hMAO-B active site. Concurrently, they exhibited low neurotoxicity and protective effects against 6-OHDA-induced damage in SH-SY5Y neuroblastoma cells. Therefore, we propose these active compounds as potential drug candidates for further investigation.

01 Jul 2026·JOURNAL OF NEUROLOGY

Combination therapy of levodopa with safinamide is more effective than with rasagiline and zonisamide in Asian Parkinson’s disease patients with motor fluctuations: a systematic review and network meta-analysis of randomized controlled trials

Review

Author: Hou, Duan-Lu ; Feng, Ya ; Li, Xuan ; Tan, Eng-King ; Yuan, Bing-Ji ; Yang, Xing-Huang ; Li, Xin-Jun ; Peng, Si-Jia ; Zhang, Yu-Lei ; Zhou, Zhi-Dong ; Wang, Xi-Xi ; Wu, Yun-Cheng ; Wang, Yu

BACKGROUND:

Selegiline, rasagiline, safinamide, and zonisamide are commonly used with levodopa to manage motor fluctuations in Parkinson's disease (PD). This study compared the efficacy and safety of these agents as adjuncts to levodopa in Asian PD patients with motor fluctuations.

METHODS:

A Bayesian network meta-analysis (NMA) was conducted. Randomized controlled trials (RCTs) published from database inception to August 31, 2025 were identified through PubMed, Embase, Web of Science, Cochrane Library, CNKI, VIP, Wanfang, and ClinicalTrials.gov. Eligible studies enrolled PD patients treated with levodopa plus any of the four agents. Primary outcomes included changes in daily OFF-time and Unified Parkinson's Disease Rating Scale (UPDRS) Part III score. This study is registered in PROSPERO (CRD42024627701).

FINDINGS:

Eleven RCTs involving 2824 patients were included, no eligible RCTs evaluating selegiline in Asian PD patients were identified for inclusion in the analysis. All combination therapies, except for zonisamide 25 mg, were more effective than levodopa plus placebo. NMA indicated that safinamide 100 mg was significantly superior to both rasagiline 1 mg and zonisamide 25 mg in reducing OFF-time (safinamide 100 mg vs. rasagiline 1 mg: MD = - 0·52, 95% CI - 0·97 to - 0·07; safinamide 100 mg vs. zonisamide 25 mg: MD = - 0·84, 95% CI - 1·46 to - 0·22) and improving UPDRS III score (safinamide 100 mg vs. rasagiline 1 mg: MD = - 2·00, 95% CI - 3·30 to - 0·67; safinamide 100 mg vs. zonisamide 25 mg: MD = - 2·50, 95% CI - 4·10 to - 0·94). Compared with zonisamide 50 mg, safinamide 100 mg showed a trend toward a reduction in OFF-time (MD = - 0·56, 95% CI - 1·18 to 0·08) and UPDRS III score (MD = - 1·40, 95% CI - 2·90 to 0·08). Safinamide 100 mg ranked first in SUCRA ranking for reducing OFF-time and UPDRS III score. These findings were robust in sensitivity analyses.

CONCLUSIONS:

The findings suggest that levodopa in combination with safinamide 100 mg is more efficacious than combinations with rasagiline 1 mg or zonisamide 25 mg for alleviating motor fluctuations and improving motor symptoms in Asian PD patients, and shows a more favourable (though not statistically significant) trend compared with zonisamide 50 mg.

27 May 2026·ChemMedChem

Design, Synthesis, and Evaluation of Coumarin‐Rasagiline Hybrids as Multifunctional Neuroprotective Agents

Article

Author: Matos, Maria João ; Barreiro, Sandra ; Carneiro, Aitor ; Machado, Claudia Sofia ; Pinto, Miguel ; Chavarria, Daniel ; Novás, Manuel ; Crucitti, Davide ; Fernandes, Carlos

The design of hybrid molecules with multifunctional profiles has emerged as a promising strategy in medicinal chemistry, particularly for tackling complex disorders such as neurodegenerative diseases. There is an urgent need for therapeutic agents capable of acting on multiple pathological targets to both control neuronal death and support the recovery of already compromised neuronal populations. In this study, we synthesized and evaluated a series of hybrid compounds combining a coumarin scaffold with an alkynylamine moiety inspired by rasagiline. These molecules were studied for their potential as human monoamine oxidase ( h MAO) inhibitors, antioxidants, and neuroprotective agents. Five compounds demonstrated inhibitory activity against h MAO‐B in the micromolar range, along with significant neuroprotective effects against oxidative stress induced by Fe 3+ (FeNTA), tert ‐butyl hydroperoxide ( t ‐BHP), and hydrogen peroxide (H 2 O 2 ). Additionally, all compounds exhibited the ability to scavenge free radicals (ABTS assay) and chelate Fe(II), further corroborating their antioxidant capacity. In addition, the absorption, distribution, metabolism, excretion, and toxicity (ADMET) properties were investigated. Docking studies and molecular dynamics simulations provide additional support for the experimental data. Collectively, these findings provide renewed evidence for the therapeutic potential of coumarin‐rasagiline hybrids as multifunctional agents for the treatment of neurodegenerative diseases.

News (Medical) associated with Rasagiline mesylate

22 Apr 2025

·www.prnewswire.com

XADAGO/EQUFINA Set to Revolutionize Parkinson's Disease Treatment Landscape | DelveInsight

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 Related Reports Parkinson's Disease Market Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease companies, including UCB Biopharma SRL, Novartis, Annovis Bio, Supernus Pharmaceuticals, Inc., Britannia Pharmaceutical, Pharma Two B, Mitsubishi Tanabe Pharma (NeuroDerm), AbbVie, Cerevel Therapeutics, Cerevance, among others. Parkinson's Disease Pipeline Parkinson's Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Parkinson's disease companies, including Cerevel Therapeutics, Inhibikase Therapeutics, Neuraly, Peptron, Biogen, Roche, Brain Neurotherapy Bio, Inc., Modag, Annovis Bio Inc., BioVie Inc., United Neuroscience Ltd., Luye Pharma Group, AbbVie, UCB Biopharma SRL, InnoMedica Schweiz AG, Integrative Research Laboratories AB, H. Lundbeck A/S, Shanghai WD Pharmaceutical Co., Ltd., Cerevance Beta, Inc., Nobilis Therapeutics Inc., BlueRock Therapeutics, Taiwan Mitochondrion Applied Technology Co., Ltd., among others. Cell and Gene Therapy in Parkinson's Disease Market Cell and Gene Therapy in Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key cell and gene therapy in Parkinson's disease companies including MeiraGTx, Hope Biosciences, Sumitomo Pharma, Prevail Therapeutics, BlueRock Therapeutics, Voyager Therapeutics, among others. Parkinson's Disease Psychosis Market Parkinson's Disease Psychosis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease psychosis companies, including Sumitomo Pharma America Inc., Vanda Pharmaceuticals, Acadia Pharmaceuticals Inc., Otsuka America Pharmaceutical, Lundbeck LLC, Jazz Pharmaceuticals, Alkahest Inc., Sandoz, Sio Gene Therapies, Axovant Sciences Ltd, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalLicense out/inPhase 2

05 Dec 2024

·www.globenewswire.com

Pharma Two B Announces Poster Presentation on P2B001 at the Annual Meeting of the Parkinson’s Disease Study Group

Pooled data analysis of efficacy and safety from Phase 2b and Phase 3 data sets in patients with early-stage Parkinson’s disease (PD) support P2B001 as a first line, once-daily treatment choice for early PD KIRYAT ONO, Israel, Dec. 05, 2024 (GLOBE NEWSWIRE) -- Pharma Two B, a private, late-stage pharmaceutical company developing innovative combination drugs for neurological disorders, today announced a poster presentation of integrated safety and efficacy data on P2B001 from its Phase 2b and Phase 3 studies in early-stage Parkinson’s disease (PD) patients. P2B001 is a fixed, low-dose extended-release (ER) combination of pramipexole, 0.6 mg and rasagiline, 0.75 mg. The data are being presented today by Henry Moore, M.D., Associate Professor of Clinical Neurology, University of Miami, Miller School of Medicine, at the Parkinson’s Study Group (PSG) 33rd Annual Meeting in Nashville, TN. “The poster includes robust safety and efficacy data from two double-blind studies, which compared once-daily P2B001 to titrated pramipexole ER (PramiER) or placebo, over a 12-week period,” said Dr. Moore, Associate Professor of Clinical Neurology at the University of Miami and presenter of the study. “P2B001 consistently demonstrated a favorable risk-benefit profile in treating PD symptoms in early-stage patients, compared to the groups receiving other, commercially available therapies. It therefore could be a valuable potential first-line therapy for such patients who are often treated by general neurologists and primary care physicians.” The poster summarizes an integrated modified-ITT analysis of Unified Parkinson’s Disease Rating Scale (UPDRS) results in 196 early-stage PD patients, as follows: P2B001 had significantly greater effect on the UPDRS Part II (Activities of Daily Living, or ADL), Part III (Motor), and Total (Parts II and III) scores versus placebo.P2B001 had comparable efficacy to individually titrated PramiER.P2B001 had significantly less worsening in daytime-sleepiness compared to those treated with PramiER.P2B001 was well-tolerated with an adverse event profile that included fewer sleep-related and dopaminergic adverse events than titrated doses of PramiER. Dan Teleman, CEO of Pharma Two B, added, “These data provide further support for P2B001 as a first-line, once-daily combination pill treatment for people with early PD that requires no titration. Currently, we are focused on completing our merger with Hepion and thereafter look forward to moving P2B001 towards an NDA submission.” About the PSG Annual Conference The 2024 Annual Meeting of the Parkinson Study Group is being held December 5-8, 2024, in Nashville, TN. For over three decades, the PSG Annual Meeting has showcased the organization’s efforts in collaborative research and a commitment to education and mentorship. The meeting welcomes leading investigators, coordinators, trainees, advocates, and allied stakeholders to exchange the latest advances and practices in PD. About Pharma Two B Pharma Two B is a private, late-stage pharmaceutical company. Pharma Two B’s mission is to improve patients’ quality of life by developing innovative, value-added combination drugs for neurological disorders, with a clear unmet need, that are based on previously approved oral drugs and that may offer meaningful clinical benefits, as well as improved safety and enhanced convenience. Pharma Two B’s lead product candidate is P2B001. For more information, please visit: www.pharma2b.com. Pharma Two B plans to go public via a merger transaction (the “Merger”) with Hepion Pharmaceuticals, Inc. (Nasdaq: HEPA) (“Hepion”) in conjunction with the closing of a concurrent private placement. The proposed merger transaction was initially announced on July 22, 2024, and on November 11, 2024, the U.S. Securities and Exchange Commission (“SEC”) declared effective the Company’s registration statement on Form F-4, as amended (the “Registration Statement”) relating to the Merger. The Merger, which has been approved by the respective boards of directors of Pharma Two B and Hepion, is expected to close in the fourth quarter of 2024 and remains subject to approval by both Pharma Two B and Hepion’s respective stockholders, regulatory approval, listing of Pharma Two B’s ordinary shares on Nasdaq under the ticker symbol “PHTB” and other customary closing conditions. About P2B001 P2B001 is an investigational, novel, fixed-dose, extended-release combination of pramipexole and rasagiline (0.6 mg/0.75 mg), both at low doses that are not commercially available. Marketed pramipexole and rasagiline are currently indicated for the treatment of PD (as monotherapy and adjunct therapy for early and more advanced patients). P2B001 is being developed for potential use as a first-line therapy for people with PD. Extended release rasagiline is a new and proprietary formulation of rasagiline developed by Pharma Two B. In a Phase 3 clinical trial, P2B001 demonstrated that it provides benefits comparable with commercially used doses of marketed pramipexole-ER (PramiER) while minimizing associated daytime sleep-related and dopaminergic side effects. Pharma Two B owns worldwide-granted patents for both pharmaceutical composition and method of treatment with P2B001. About Hepion Pharmaceuticals Hepion is a biopharmaceutical company headquartered in Edison, New Jersey, previously focused on the development of drug therapy for treatment of chronic liver diseases. This therapeutic approach targets fibrosis, inflammation, and shows potential for the treatment of hepatocellular carcinoma (“HCC”) associated with non-alcoholic steatohepatitis (“NASH”), viral hepatitis, and other liver diseases. Hepion’s cyclophilin inhibitor, rencofilstat, was being developed to offer benefits to address multiple complex pathologies related to the progression of liver disease. In December 2023, Hepion’s board of directors approved a strategic restructuring plan to preserve capital by reducing operating costs. Additionally, Hepion initiated a process to explore a range of strategic and financing alternatives focused on maximizing stockholder value within the current financial environment and NASH drug development landscape. On April 19, 2024, Hepion announced that it has begun wind-down activities in its ASCEND- NASH clinical trial which wind-down activities have since been completed and the trial has been closed. Hepion is continuing efforts, to the extent that cash is available, to provide any value derived from rencofilstat to its shareholders. Forward-Looking Statements Certain statements in this press release may be considered “forward-looking statements”. Forward-looking statements generally relate to future events or Hepion’s or Pharma Two B’s future financial or operating performance. For example, express or implied statements regarding Hepion and Pharma Two B’s expectations with respect to the Merger, including the timing of the Special Meeting, listing Pharma Two B’s ordinary shares on Nasdaq, receipt of necessary shareholder approvals and the timing of closing of the Merger, and related matters, as well as all other statements other than statements of historical fact included in this press release, are forward-looking statements. When used in this press release, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and similar expressions, as they relate to Hepion or Pharma Two B, identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, Hepion’s and Pharma Two B’s management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors detailed in Hepion’s and Pharma Two B’s filings with the SEC. Most of these factors are outside the control of Hepion and/or Pharma Two B and are difficult to predict. In addition to factors disclosed in Hepion’s and Pharma Two B’s filings with the SEC, the following factors, among others, could cause actual results and the timing of events to differ materially from the anticipated results or other expectations expressed in the forward-looking statements: the risk that the Merger may not be completed in the fourth quarter of 2024 or at all; the inability to meet the closing conditions to the Merger, including the failure of Pharma Two B to meet Nasdaq initial listing standards in connection with the consummation of the Merger; costs related to the Merger and the failure to realize anticipated benefits of the Merger or to realize estimated pro forma results with respect thereto as well as other risks associated with biopharmaceutical companies generally, including the risks of filing an NDA, obtaining regulatory approval for any product candidates, commercialization of any approved product, including P2B001 for PD, as well as the total addressable market and potential for success of P2B001, the presentation of financial information in U.S. GAAP, completion of a PCAOB audit of U.S. GAAP financials, as well as other risks set forth in more detail in the Registration Statement. The forward-looking statements are based upon management’s beliefs and assumptions; and other risks and uncertainties identified in the Registration Statement, including those under “Risk Factors” therein, and in other filings with the SEC made by Hepion. Each of Hepion and Pharma Two B undertake no obligation to update these statements for revisions or changes after the date of press release, except as required by law. No Offer or Solicitation This press release does not constitute an offer to sell or a solicitation of an offer to buy, or the solicitation of any vote or approval in any jurisdiction in connection with the Merger or any related transactions, nor shall there be any sale, issuance or transfer of securities in any jurisdiction where, or to any person to whom, such offer, solicitation or sale may be unlawful. Any offering of securities or solicitation of votes regarding the proposed transaction will be made only by means of a proxy statement/prospectus that complies with applicable rules and regulations promulgated under the Securities Act, and the Securities Exchange Act of 1934, as amended, or pursuant to an exemption from the Securities Act or in a transaction not subject to the registration requirements of the Securities Act. Additional Information and Where to Find It In connection with the Merger, Pharma Two B filed the Registration Statement with the SEC, which includes a prospectus with respect to its securities to be issued in connection with the Merger, and a definitive proxy statement with respect to Hepion’s stockholder meeting at which Hepion’s stockholders will be asked to vote on the Merger and related matters. The Registration Statement has been declared effective by the SEC and Hepion is mailing a definitive proxy statement and prospectus to its shareholders. Each of Hepion and Pharma Two B urge investors, stockholders, and other interested persons to read, when available, the Registration Statement including the proxy statement/prospectus, any amendments thereto, and any other documents filed with the SEC, before making any voting or investment decision because these documents will contain important information about the Merger. Investors and security holders will be able to obtain free copies of the Registration Statement, the proxy statement prospectus and all other relevant documents filed or that will be filed with the SEC by Pharma Two B or Hepion through the website maintained by the SEC at www.sec.gov. Participants in the Solicitation Pharma Two B and Hepion and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from Hepion’s stockholders in connection with the Merger. Information about Hepion’s directors and executive officers and their ownership of Hepion’s securities is set forth in Hepion’s filings with the SEC. To the extent that holdings of Hepion’s securities have changed since the amounts printed in Hepion’s Annual Report on Form 10-K/A, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC. A list of the names of such directors and executive officers and information regarding their interests in the Merger is contained in the proxy statement/prospectus in the Registration Statement. You may obtain free copies of these documents as described in the preceding paragraph. Contact: Pharma Two BDan TelemanCEOPharma Two B Ltd.Cell: + 972-54-550-0804Email: dan@pharma2b.comwww.pharma2b.com U.S. investors Chuck PadalaLifeSci Advisors, LLC+1-917-741-7792chuck@lifesciadvisors.com

Clinical ResultPhase 2Phase 3Acquisition

14 Nov 2024

·www.globenewswire.com

Pharma Two B and Hepion Pharmaceuticals, Inc. Announce Effectiveness of Registration Statement Related to Proposed Merger

Nov. 11, 2024 -- Pharma Two B Ltd. (“Pharma Two B”), a late-clinical stage company that is developing P2B001, an innovative combination product candidate for the treatment of Parkinson’s Disease (“PD”) and Hepion Pharmaceuticals, Inc. (Nasdaq: HEPA) (“Hepion”), a clinical stage biopharmaceutical company that had been developing a treatment for non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma (“HCC”), and other chronic liver diseases, today jointly announced that the U.S. Securities and Exchange Commission ("SEC") has declared effective the registration statement on Form F-4 (as amended, the "Registration Statement") filed with the SEC related to Pharma Two B’s merger transaction with Hepion as previously announced on July 22, 2024 (the “Proposed Transaction”). The Proposed Transaction, which has been approved by the respective boards of directors of Pharma Two B and Hepion, is expected to close in the fourth quarter of 2024 and remains subject to approval by both Pharma Two B and Hepion’s respective stockholders, regulatory approval, listing of Pharma Two B’s ordinary shares on Nasdaq under the ticker symbol “PHTB” and other customary closing conditions. Upon the anticipated closing of the Proposed Transaction, the combined company will operate under the “Pharma Two B” name. Hepion also announced that a special meeting (the “Special Meeting”) of its stockholders will be held on December 12, 2024 to approve the Proposed Transaction. The Special Meeting will be held at 9:00 a.m. Eastern Time via live webcast at www.virtualshareholdermeeting.com/HEPA2024SM. Hepion stockholders of record at the close of business on the record date of November 6, 2024 are entitled to vote at the Special Meeting. Hepion filed its definitive proxy statement/prospectus relating to the Proposed Transaction with the SEC and will mail it to stockholders on or about November 8, 2024. More details about the Proposed Transaction and the resolutions to be voted upon at the Special Meeting can be found in the definitive proxy statement/prospectus, available at http://www.sec.gov. Hepion stockholders who need assistance in completing the proxy card, need additional copies of the proxy statement/prospectus, or have questions regarding the Special meeting may contact Hepion’s proxy solicitor, Campaign Management, by calling 1-855-422-1042 or emailing info@campaign-mgmt.com. A.G.P./Alliance Global Partners is serving as financial advisor to Hepion and Sheppard, Mullin, Richter & Hampton LLP is acting as U.S. legal advisor to Hepion and Lipa Meir & Co.is acting as Israeli legal advisor to Hepion. Sullivan & Worcester LLP is serving as legal advisor to A.G.P. Laidlaw & Company (UK) Ltd. is acting as financial advisor to Pharma Two B. and Meitar Law Offices and Goodwin Procter LLP are acting as legal advisors to Pharma Two B. Pharma Two B is a private, late-stage pharmaceutical company. Pharma Two B’s mission is to improve patients’ quality of life by developing innovative, value-added combination drugs for neurological disorders, with a clear unmet need, that are based on previously approved oral drugs and that may offer meaningful clinical benefits, as well as improved safety and enhanced convenience. Pharma Two B’s lead product candidate is P2B001. For more information, please visit: www.pharma2b.com. P2B001 is an investigational, novel, fixed-dose, extended-release combination of pramipexole and rasagiline (0.6 mg/0.75 mg), both at low doses that are not commercially available. Marketed pramipexole and rasagiline are currently indicated for the treatment of PD (as monotherapy and adjunct therapy for early and more advanced patients). P2B001 is being developed for potential use as a first-line therapy for people with PD. Extended release rasagiline is a new and proprietary formulation of rasagiline developed by Pharma Two B. In a Phase 3 clinical trial, P2B001 demonstrated that it provides benefits comparable with commercially used doses of marketed pramipexole-ER (PramiER) while minimizing associated daytime sleep-related and dopaminergic side effects. Pharma Two B owns worldwide-granted patents for both pharmaceutical composition and method of treatment with P2B001. Hepion is a biopharmaceutical company headquartered in Edison, New Jersey, previously focused on the development of drug therapy for treatment of chronic liver diseases. This therapeutic approach targets fibrosis, inflammation, and shows potential for the treatment of hepatocellular carcinoma (“HCC”) associated with non-alcoholic steatohepatitis (“NASH”), viral hepatitis, and other liver diseases. Hepion’s cyclophilin inhibitor, rencofilstat, was being developed to offer benefits to address multiple complex pathologies related to the progression of liver disease. In December 2023, Hepion’s board of directors approved a strategic restructuring plan to preserve capital by reducing operating costs. Additionally, Hepion initiated a process to explore a range of strategic and financing alternatives focused on maximizing stockholder value within the current financial environment and NASH drug development landscape. On April 19, 2024, Hepion announced that it has begun wind-down activities in its ASCEND- NASH clinical trial which wind-down activities have since been completed and the trial has been closed. Hepion is continuing efforts, to the extent that cash is available, to provide any value derived from rencofilstat to its shareholders. The content above comes from the network. if any infringement, please contact us to modify.

Acquisition

100 Deals associated with Rasagiline mesylate

External Link

KEGG	Wiki	ATC	Drug Bank
D02562	Rasagiline mesylate	N04BD02	DB01367

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Parkinson Disease	European Union	Teva Pharmaceuticals Europe BV	21 Feb 2005
Parkinson Disease	Iceland	Teva Pharmaceuticals Europe BV	21 Feb 2005
Parkinson Disease	Liechtenstein	Teva Pharmaceuticals Europe BV	21 Feb 2005
Parkinson Disease	Norway	Teva Pharmaceuticals Europe BV	21 Feb 2005

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Motor Disorders	Phase 3	-	H. Lundbeck A/S	01 Jan 2011
Restless Legs Syndrome	Phase 3	United States	Teva Neuroscience, Inc.	01 Sep 2010
Supranuclear Palsy, Progressive	Phase 3	Germany	Teva Branded Pharmaceutical Products R&D LLC	01 Jan 2010
Multiple System Atrophy	Phase 2	United States	H. Lundbeck A/S	01 Dec 2009
Multiple System Atrophy	Phase 2	Austria	H. Lundbeck A/S	01 Dec 2009
Multiple System Atrophy	Phase 2	Canada	H. Lundbeck A/S	01 Dec 2009
Multiple System Atrophy	Phase 2	France	H. Lundbeck A/S	01 Dec 2009
Multiple System Atrophy	Phase 2	Germany	H. Lundbeck A/S	01 Dec 2009
Multiple System Atrophy	Phase 2	Hungary	H. Lundbeck A/S	01 Dec 2009
Multiple System Atrophy	Phase 2	Israel	H. Lundbeck A/S	01 Dec 2009

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


MDS2025 \| EAN2025	Not Applicable	Parkinson Disease	160	Selegiline (SL)	cuaojqwvwx(djfplgthpp) = huxbyuuasd gfofanrlii (ftszvlbhrd )	Positive	05 Oct 2025
				Rasagiline (RS)	-
NCT03727139 (JapicCTI-184181, Pubmed \| Expert Opin Drug Saf)	Not Applicable	Parkinson Disease	961	Rasagiline 1 mg once daily	qmovctrctg(mfhzefnjqa) = rggyiesgrb prtvonavjp (kmczcnwljb )	Positive	02 Jan 2024
NCT02789020 (CTgov)	Phase 2	Parkinson Disease	96	functional Magnetic Resonance Imaging+Rasagiline (Rasagiline)	bzfnedisgt(vufibjabnq) = yghvvdubwj ohgtaspgmm (dkqalbmlbq, 0.01) View more	-	06 Sep 2023
				functional Magnetic Resonance Imaging (Placebo)	bzfnedisgt(vufibjabnq) = gqxhtgmpvh ohgtaspgmm (dkqalbmlbq, 0.01) View more
NCT02359552 (R2, CTgov)	Phase 2	Alzheimer Disease	50	Placebo (Placebo)	shyxwzqjcm(lcjjmvfsrb) = ksatdnxymt wdtdfyzguh (ewhxkamcqs, 0.030) View more	-	20 Oct 2020
				Rasagiline (Rasagiline)	shyxwzqjcm(lcjjmvfsrb) = kkentdkihv wdtdfyzguh (ewhxkamcqs, 0.030) View more
NCT01786603 (CTgov)	Phase 2	Amyotrophic Lateral Sclerosis	80	Rasagiline (Rasagiline)	bowrpmhyfh(aeolqqrnrf) = czhqvxtgwb whokeggsgi (kwunfrjhvo, ugvfkjhpqm - dsqvbnsgqe) View more	-	27 Jan 2020
				Placebo (Placebo)	bowrpmhyfh(aeolqqrnrf) = dqdzfzvaat whokeggsgi (kwunfrjhvo, nwvmlzwlba - drfeqiwemd) View more
NCT02337764 (CTgov)	Phase 3	Parkinson Disease	222	TVP-1012	ssymmsrdys = vndtdmuhgu jjijynlsfa (oxfazhrnlc, higmzjtpix - mruaubwfth) View more	-	19 Apr 2019
NCT02337725 (Pubmed) Manual	Phase 3	Parkinson Disease	244	Rasagiline	iidmzrkgiu(ugejztjecw): difference = -6.39 (95% CI, -8.530 to -4.250), P-Value = <0.0001 View more	Positive	01 Mar 2019
				Placebo
NCT02337751 (Pubmed \| J Neural Transm (Vienna))	Phase 3	Parkinson Disease	210	Placebo	wlgdoefqxb(fwbcplvhni) = pgdkzokjld odjcmronhs (rfdfnltqrg ) View more	-	01 Mar 2019
				Rasagiline 1 mg/day	wlgdoefqxb(fwbcplvhni) = ssrnniensr odjcmronhs (rfdfnltqrg ) View more
NCT02337751 (CTgov)	Phase 3	Parkinson Disease	198	Placebo+TVP-1012 (Placebo + TVP-1012 Group)	lxymqexhwq = hpcftuwnwz gkepkqwoma (suqaskivbd, gpxxczrzwz - ypxbybldov) View more	-	28 Feb 2019
				TVP-1012 (TVP-1012 + TVP-1012 Group)	lxymqexhwq = dteflvqmnn gkepkqwoma (suqaskivbd, pelizveprb - fppfzvhvvn) View more
NCT02337738 (CTgov)	Phase 2/3	Parkinson Disease	404	Placebo	wkughdwwcr(fphoirephp) = wojhbovhcs nsfhtibapn (tkxjcwpbhb, 0.167) View more	-	28 Feb 2019

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