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Last update 02 Apr 2026

Glatiramer Acetate

Last update 02 Apr 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Polymer

Synonyms

(T,G)-A-L, COP 1, Copolymer 1

+ [16]

Target-

Action

modulators

Mechanism

Immunomodulators

Therapeutic Areas

Immune System DiseasesNervous System DiseasesOther Diseases

Active Indication

Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingMultiple Sclerosis, Primary Progressive+ [1]

Inactive Indication

Acute decompensated heart failureAmyotrophic Lateral SclerosisCrohn Disease+ [4]

Originator Organization

Weizmann Institute of Science

Active Organization

Consegna Pharma, Inc.

Teva-Handok Pharma Co., Ltd.

Viatris, Inc.

+ [6]

Inactive Organization

Teva Branded Pharmaceutical Products R&D LLC

Weizmann Institute of Science

Teva Pharmaceutical Industries Ltd.

+ [1]

License Organization

Shanghai Pharmaceutical Co., Ltd.

Teva Pharmaceutical Industries Ltd.

Takeda Pharmaceutical Co., Ltd.

+ [2]

Drug Highest PhaseApproved

First Approval Date

United States (20 Dec 1996),

Multiple Sclerosis, Relapsing-Remitting

RegulationOrphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea)

Structure/Sequence

Molecular FormulaC25H45N5O13

InChIKeyFHEAIOHRHQGZPC-KIWGSFCNSA-N

CAS Registry147245-92-9

Sequence Code 321794895

Clinical Trials associated with Glatiramer Acetate

NCT07189325

/ Not yet recruitingPhase 3IIT

A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis

Multiple sclerosis (MS), the main central nervous system autoimmune disorder, is the first cause of non-traumatic disability in young adults and has thus significant individual consequences with elevated public health cost. It commonly starts during the third and fourth decades. Over the last twenty years, several disease-modifying therapies with variable benefit/risk profiles have been introduced leading to dramatic changes in the prognosis of MS.
First, several moderately effective therapies , with good safety profile, have allowed to decrease the frequency of relapses along with a possible, albeit limited, effect on medium- and long-term disability.
More recently highly effective therapies (HET), with immunosuppressive properties, have dramatically reduced clinical and MRI disease activity and significantly improved patient's prognosis.
Anti-CD20 therapies (B-cells depleting therapies, given either intravenous or subcutaneous), one of the main HET, have demonstrated higher efficacy than platform therapies in several phase 3 randomized clinical trials and their use within the very first years of the disease seems to be associated with improved long-term outcomes.
Taking all of this into account, the investigators hypothesize that RRMS patients who experience a de-escalation from anti-CD20 therapies to platform therapies after 40 years will not experience disease activity accrual and disability worsening.

Start Date01 Sep 2025

Sponsor / Collaborator

University Hospital of Montpellier

NCT05344469

/ RecruitingNot Applicable

A Non-interventional Study Evaluating Injectable Treatments (Ofatumumab, Glatiramer Acetate and Interferon β1) and Oral Treatments (Teriflunomide, Dimethyl Fumarate and Diroximel Fumarate) in Patients With Relapsing Multiple Sclerosis [AIOLOS]

This is an observational, non-interventional, multicenter, open-label study in patients being treated with any approved injectable or selected oral DMT for RMS in Germany.
Prospective, primary data will be collected via questionnaires and an electronic case report form (eCRF) over a period of up to four years. Additionally, medical history of participants will be collected including disease duration, laboratory values, EDSS, MRI parameters and relapses.

Start Date10 May 2022

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT05688436

/ RecruitingNot Applicable

Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

In this study, researchers will learn more about the effects of diroximel fumarate (DRF), also known as VUMERITY®, when taken during pregnancy in people with multiple sclerosis, also known as MS. In MS, the immune system attacks the nerves in the brain and spinal cord. The affected areas are called lesions. The damage makes it difficult for the brain and spinal cord to function and send messages throughout the body. MS can be a progressive disease, which means it may get worse over time. In relapsing forms of MS (RMS), new symptoms may happen, and existing symptoms may get better or worse over time. DRF is an approved drug that is used to treat people with RMS.
This is known as an "observational" study, which collects health information about study participants without changing their medical care. The main goal of this study is to collect birth and health information from 3 groups of participants and their babies. These groups are:
* Those who took DRF during their pregnancy
* Those who took other drugs for RMS during their pregnancy, but not DRF
* Those who did not take any drugs for RMS during their pregnancy
The main question researchers want to learn about in this study is:
• How many participants' babies were born with major congenital malformations (MCMs)? MCMs are problems with how a baby's body forms before birth.
Researchers will also learn more about:
* Loss of the baby before 20 weeks of pregnancy
* Loss of the baby at and after 20 weeks of pregnancy
* How many babies are born early (at or before 37 weeks)
* How many babies are small for their age while in the participant's uterus
* How many babies are born with any sign of life
This study will be done as follows:
* Participants with RMS can join this study if they become pregnant from 29th October 2019 to 31st July 2030. Information will start being collected when the participant decides to join the study.
* The participants' medical records will be reviewed 2 times during the study - once when the study is halfway done, and one at the end of the study.
* Each participant will be in the study until the end of their pregnancy. Each baby will be in the study for up to 1 year after birth.
* The study is planned to end by 30th April 2031.

Start Date24 Sep 2021

Sponsor / Collaborator

Biogen, Inc.

100 Clinical Results associated with Glatiramer Acetate

100 Translational Medicine associated with Glatiramer Acetate

100 Patents (Medical) associated with Glatiramer Acetate

2,134

Literatures (Medical) associated with Glatiramer Acetate

01 May 2026·Multiple Sclerosis and Related Disorders

Real-world evaluation of the transition between originator and follow-on glatiramer acetate in people with multiple sclerosis: the “GA transition” study

Article

Author: Rasia, Sarah ; Annovazzi, Pietro ; Schiavetti, Irene ; Lus, Giacomo ; Cavalla, Paola ; Pasquali, Livia ; Laroni, Alice ; Sormani, Maria Pia ; La Gioia, Sara ; Carbone, Alessio ; Caleri, Francesca ; Di Sapio, Alessia ; Giovannini, Beatrice ; Signoriello, Elisabetta ; Pozzato, Mattia ; Zecca, Chiara ; Cordioli, Cinzia ; Torri Clerici, Valentina

INTRODUCTION AND OBJECTIVE:

The introduction of follow-on formulations of glatiramer acetate (GA) has raised questions regarding their equivalence to the originator in real-world practice. This study aimed to evaluate the clinical effectiveness and safety of switching from originator GA to its follow-on product, Copemyl® (CO), in people with multiple sclerosis (MS).

METHODS:

A multicenter, retrospective observational study was conducted, including patients with MS treated for at least two years with GA followed by at least two years with CO. The primary outcome was the annualized relapse rate (ARR), whereas secondary outcomes included disability progression assessed by the Expanded Disability Status Scale (EDSS), MRI activity, and adverse events (AEs).

RESULTS:

A total of 138 patients were included. The ARR was very low and comparable across treatments (GA: 0.028; CO: 0.019), with a mean paired difference of -0.009 (95 % CI -0.028 to 0.010; p = 0.38), falling within the predefined equivalence margin. Disability progression over six months occurred in 6.0 % of GA and 7.3 % of CO periods (HR 1.53; 95 % CI 0.74-3.16; p = 0.26). No significant difference was found in MRI activity (52.2 % vs 60.1 %, p = 0.14). Safety profiles were comparable, with mostly mild to moderate AEs; four serious AEs occurred under CO, two of them possibly treatment-related.

CONCLUSIONS:

Switching from originator GA to CO did not influence clinical outcomes or safety. These findings support the therapeutic equivalence of the two formulations in real-world clinical practice, by supporting previous evidence from randomized trials.

03 Mar 2026·Multiple Sclerosis Journal

Pharmacogenomics of response to interferon-beta and glatiramer acetate in Multiple Sclerosis: A multi-centric study.

Article

Author: Filippi, Massimo ; Kockum, Ingrid ; Olsson, Tomas ; Goris, An ; Saarela, Janna ; Harroud, Adil ; Rocca, Maria Assunta ; Piehl, Fredrik ; D'alfonso, Sandra ; Stridh, Pernilla ; Mingione, Alessandra ; Zollo, Alen ; Martinelli Boneschi, Filippo ; Harbo, Hanne Flinstad ; Giordano, Antonino ; Pääkkönen, Kimmo ; Søndergaard, Helle Bach ; Dubois, Bénédicte ; Shchetynsky, Klementy ; Mascia, Elisabetta ; Sorosina, Melissa ; Priori, Alberto ; Corona, Andrea ; Clarelli, Ferdinando ; Hemmer, Bernhard ; Sellebjerg, Finn ; Esposito, Federica

BACKGROUND:

Multiple sclerosis (MS) treatment response varies significantly, hindering effective management and necessitating better predictive biomarkers. Pharmacogenomics offers a promising avenue to identify genetic markers that, combined with clinico-demographic predictors, could enhance personalized therapeutic decisions.

OBJECTIVES:

This multi-center study investigated genetic determinants of response to interferon-beta (IFN-β) and glatiramer acetate (GA) in European ancestry patients with relapsing-remitting MS (RRMS).

METHODS:

After harmonization and quality control, we tested over 6 million genetic variants. We used negative binomial regression, meta-analysis, and gene-set enrichment to link variants, genes, and biological pathways to treatment response.

RESULTS:

In 679 GA and 1614 IFN-β patients, the top GA variant was rs2053696A in MAP3 K1 (p = 3.97*10^-9), involved in key signaling pathways. Another significant GA signal was in WWOX. For IFN-β, no genome-wide significant variants were found, but suggestive signals emerged near ZMIZ1, ZCCHC7, and other genes linked to immune function and interferon signaling. Gene-set analysis revealed IL-17 regulation for GA and ion channel pathways for IFN-β.

CONCLUSION:

This study identified novel genetic variants for GA response, implicating genes in crucial pathways. For IFN-β, suggestive signals point to immune and interferon-related genes. These findings enhance our understanding of genetic influences on RRMS treatment response, while highlighting pharmacogenomic research challenges.

01 Mar 2026·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Lyophilized formulation development and characterization of stable glatiramer acetate/oligonucleotide polyplexes at clinically therapeutic strengths

Article

Author: Luan, Xi ; Berkland, Cory J ; Laird Forrest, M ; Gong, Huan ; Daniel Griffin, J ; Abdelaziz, Moustafa M ; Hageman, Michael J

Glatiramer acetate (GA) electrostatically complexes with cytosine-guanine oligodeoxynucleotides (CpG ODN), forming ∼100 nm cationic nanoparticles that localize this potent immunostimulant to the injection site. We previously reported GA-CpG nanoparticles retained the anti-tumor activity of CpG while mitigating systemic immune-related adverse events. Nonetheless, nanoparticulate systems like polypeptide-oligonucleotide complexes pose challenges with reproducible production, in-use stability, and storage stability, which must be solved before translation for clinical use. In this study, we systematically investigated a microfluidic mixing process to define reproducible production of GA-CpG nanoparticles. Dynamic light scattering measurements revealed significantly smaller and more uniform nanoparticles for microfluidic processing versus traditional mixing via pipette. We screened a range of buffer systems to determine the pH and ion types that could maintain colloidal stability and CpG potency. Buffer screening tests indicated that amino acid buffers, particularly glutamic acid, better maintained particle consistency than commonly used parenteral buffers. Finally, formulations of potential lyoprotectants and GA-CpG nanoparticles were developed. Freeze-thaw and freeze-drying experiments were conducted to assess the effects of buffers and lyoprotectants. Formulations with 5% HP-β-CD or trehalose yielded mean particle sizes of less than 127 nm and retained even after storage for 6 months at 40 °C/75% relative humidity. The work on electrostatic complexes reported here may provide valuable guidance to formulators aiming to optimize polypeptide-based oligonucleotide polyplex products for in-use or long-term stability.

148

News (Medical) associated with Glatiramer Acetate

31 Mar 2026

·www.prnewswire.com

Immunic Strengthens Its Board of Directors with the Appointment of Seasoned Biopharmaceutical Executive Jon Congleton

– Nearly 40-Year Biopharmaceutical Professional with Deep CNS and Commercial Leadership Experience in Multiple Sclerosis – – Served on Original Team Responsible for the Launch of Copaxone® in the United States – NEW YORK, March 31, 2026 /PRNewswire/ -- Immunic, Inc. (Nasdaq: IMUX), a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases, today announced the appointment of Jon Congleton, a seasoned biopharmaceutical executive with nearly 40 years of experience spanning drug development, commercialization and corporate leadership, to its Board of Directors, effective March 27, 2026. Mr. Congleton has a strong track record of building and leading biopharmaceutical organizations and advancing innovative therapies. During his career, he has worked across cardiovascular, gastrointestinal, and central nervous system (CNS) organizations, with a focus on delivering solutions for patients and their caregivers. He played a key role in the U.S. launch of Teva Pharmaceuticals Industries Ltd.'s Copaxone®, a subcutaneous injection treatment for relapsing forms of multiple sclerosis (MS), and led the U.S. operations when it became the number one prescribed MS treatment. Mr. Congleton currently serves as Chief Executive Officer (CEO) and member of the Board of Directors of Mineralys Therapeutics, Inc., focused on aldosterone-driven cardiorenal conditions. As CEO, he guided the company from an early-stage private entity to the publicly traded, pre-commercial biotechnology firm it is today. Previously, he served as CEO and Board member of both CNS company Impel NeuroPharma, Inc. and cystic fibrosis company Nivalis Therapeutics, Inc.. Earlier, Mr. Congleton held several senior leadership roles at Teva Pharmaceuticals, eventually leading its United States and Canadian neuroscience businesses and global CNS franchise. "MS remains a devastating disease for the patients and their families. Jon's deep CNS expertise and proven track record in late-stage drug development and commercialization will be invaluable as we advance vidofludimus calcium through its pivotal clinical milestones and toward potential regulatory approval and commercial launch," stated Simona Skerjanec, M.Pharm, MBA, Interim Chairperson of the Board of Directors of Immunic. "I am thrilled that Jon is joining us at this critical moment as we evolve our Board to support Immunic in its transition into a fully integrated commercial-stage company." "I am excited to join Immunic's Board at such a pivotal moment for the company's MS program," added Mr. Congleton. "Vidofludimus calcium represents a potentially transformative opportunity for MS patients, offering advantages over currently available therapies, particularly with its unique combination of neuroprotective, anti-inflammatory and anti-viral effects as well as its favorable safety and tolerability profile shown to date. I look forward to working with the Board and the leadership team and contributing my experience to support Immunic as it advances toward the pivotal trial readouts later this year and long-term value creation." About Immunic, Inc. Immunic, Inc. (Nasdaq: IMUX) is a late-stage biotechnology company pioneering the development of novel oral therapies for neurologic diseases. The company's lead development program, vidofludimus calcium (IMU-838), is currently in phase 3 clinical trials for the treatment of relapsing multiple sclerosis, for which top-line data is expected to be available by the end of 2026. It has already shown therapeutic activity in phase 2 clinical trials in relapsing-remitting multiple sclerosis, progressive multiple sclerosis and other diseases. Vidofludimus calcium combines neuroprotective effects, through its mechanism as a first-in-class nuclear receptor-related 1 (Nurr1) activator, with additional anti-inflammatory and anti-viral effects, by selectively inhibiting the enzyme dihydroorotate dehydrogenase (DHODH). The company's development pipeline also includes earlier-stage programs, including IMU-856 and IMU-381, aimed at building a broader therapeutics platform addressing neurodegenerative, chronic inflammatory, and autoimmune-related diseases. For further information, please visit: . Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, sufficiency of cash and cash runway, expected timing, development and results of clinical trials, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Immunic's development programs and the targeted diseases; the potential for Immunic's development programs to safely and effectively target diseases; preclinical and clinical data for Immunic's development programs; the timing of current and future clinical trials, anticipated clinical milestones and regulatory approvals; the nature, strategy and focus of the company and further updates with respect thereto; the development and commercial potential of any product candidates of the company; expectations regarding the capitalization, resources and ownership structure of the company; new appointments to Immunic's board of directors; and the executive and board structure of the company. Immunic may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on management's current expectations and involve substantial risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, increasing inflation, tariffs and macroeconomics trends, impacts of the Ukraine – Russia conflict and the conflict in the Middle East on planned and ongoing clinical trials, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient financial and other resources to meet business objectives and operational requirements, and the ability to raise sufficient capital to continue as a going concern, the fact that the results of earlier preclinical studies and clinical trials may not be predictive of future clinical trial results, any changes to the size of the target markets for the company's products or product candidates, the protection and market exclusivity provided by Immunic's intellectual property, risks related to the drug development and the regulatory approval process and the impact of competitive products and technological changes. A further list and descriptions of these risks, uncertainties and other factors can be found in the section captioned "Risk Factors," in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 26, 2026, and in the company's subsequent filings with the SEC. Copies of these filings are available online at or ir.imux.com/sec-filings. Any forward-looking statement made in this release speaks only as of the date of this release. Immunic disclaims any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. Immunic expressly disclaims all liability in respect to actions taken or not taken based on any or all of the contents of this press release. Contact Information Immunic, Inc. Jessica Breu Vice President Investor Relations and Communications +49 89 2080 477 09 [email protected] US IR Contact Rx Communications Group Paula Schwartz +1 917 633 7790 [email protected] US Media Contact KCSA Strategic Communications Caitlin Kasunich +1 212 896 1241 [email protected] SOURCE Immunic, Inc. 21% more press release views with Request a Demo

Phase 2Executive ChangePhase 3

31 Mar 2026

·www.biospace.com

Sub-Q Bionics Closes $1.5M Pre-Seed Round to Advance Next-Generation Solution for Lymphedema Care

STILLWATER, Minn. & TEL AVIV, Israel--(BUSINESS WIRE)--Sub-Q Bionics, a medical device company developing next-generation solutions to improve care for patients living with lymphedema, today announced the successful close of its $1.5 million pre-seed funding round. The round includes investment from Mayo Clinic and Yeda, the technology transfer company of the Weizmann Institute of Science, as well as several private investors. The Israel Innovation Authority also provided matching funds. The funding will enable Sub-Q Bionics to continue to develop its novel bionic lymph node technology designed to transform how lymphedema is managed, based on scientific innovations from the Weizmann Institute and Shamir Medical Center. The system aims to provide a solution to manage fluid with a subcutaneous implant that will allow patients freedom of movement, automatic fluid management and reduction of symptoms such as pain and swelling. Lymphedema affects millions of patients worldwide, especially breast cancer survivors, and remains significantly underserved by existing therapeutic options. “Our mission at Sub-Q Bionics is to meaningfully improve the standard of care for patients living with lymphedema,” said Jordan Pollack, CEO of Sub-Q Bionics. “This funding enables us to accelerate development of our technology and move toward critical pre-clinical milestones while building the regulatory and commercial foundation needed to ultimately serve patients.” As part of the round, Mayo Clinic will collaborate with Sub-Q Bionics on research and development activities. Yeda also supported Sub-Q Bionics through its venture creation platform, WIN (Weizmann Innovation Nest), which identifies and builds companies around high-potential scientific discoveries originating at the Institute. WIN works closely with researchers and entrepreneurs to bring early-stage technologies to proof-of-concept and position them for company formation and investment. “Sub-Q is a great example of what we aim to build at Yeda and WIN - strong ventures rooted in outstanding science and focused on real world solutions,” said Elik Chapnik, CEO of Yeda. “We’re excited to support the team on their mission to build a technology that can change the lives of so many patients living with lymphatic diseases.” Sub-Q Bionics plans to capitalize on the funding from this round to further advance development efforts, refine its regulatory strategy, and further develop its commercial strategy. Sub-Q Bionics expects to open its seed funding round in Q2 2026. About Sub-Q Bionics Sub‑Q Bionics is a medical technology company developing an implantable lymphatic drainage system intended to manage lymphedema, a chronic condition often experienced by cancer survivors. The company’s technology is designed to assist lymphatic circulation through an implantable device that works beneath the skin to help move lymphatic fluid and address the swelling, discomfort, and mobility limitations associated with the disease. The company is headquartered in Stillwater, Minnesota. About Yeda Yeda is the commercial arm of the Weizmann Institute of Science, dedicated to translating groundbreaking discoveries into life-changing products. For decades, Yeda has been at the forefront of academic technology transfer, driving the commercialization of breakthrough drugs including Copaxone®, Rebif®, Erbitux®, Humira®, and Yescarta®. By partnering with leading companies worldwide, Yeda continues to bridge the gap between cutting-edge science and global impact. About the Weizmann Institute of Science The Weizmann Institute of Science in Israel is one of the world’s top-ranking multidisciplinary research institutions. Noted for its wide-ranging exploration of the natural and exact sciences, Weizmann Institute’s scientists are advancing research on the human brain, artificial intelligence, sustainability, computer science and encryption, astrophysics and particle physics, and are tackling diseases such as cancer, while also addressing climate change through environmental, ocean, and plant sciences. Contacts Jordan Pollack, Sub-Q Bionics CEO & Co-Founder Jordan.pollack@subqbionics.com

06 Feb 2026

·www.globenewswire.com

Mapi Pharma to Present New Safety and Efficacy Data from Glatiramer Acetate Depot Long-Acting Injection Phase II Study in Patients with Primary Progressive Multiple Sclerosis (PPMS) at ACTRIMS Forum 2026

Feb. 03, 2026 -- Mapi Pharma Ltd., a fully integrated, late-stage clinical development biopharmaceutical company focused on introducing innovative long-acting depot injectable treatments, will present new safety and efficacy data from the GA Depot Phase II study in primary progressive multiple sclerosis (PPMS) at the ACTRIMS Forum 2026 Conference, to take place February 5-7, 2026, in San Diego, CA. GA Depot is a long-acting injection version of the approved Glatiramer Acetate (GA, commercially available as Copaxone®/Glatopa®). PPMS is characterized by continued worsening neurologic function from the onset of symptoms, without early relapses or remissions. GA Depot is administered intramuscularly (IM) once every 28 days. Mapi utilizes extended-release depot technologies for the development of long-acting injections as lifecycle management products. The products are based on existing commercially successful pharmaceuticals across multiple therapeutic areas (diabetes, weight control, schizophrenia and oncology) and are protected by strong IP. Mapi recently received the Israeli Ministry of Health’s GMP (Good Manufacturing Practice) approval, enabling the initiation of a Phase III study of GA Depot in PPMS in 2026 and commercial launch of the product in relapsing forms of multiple sclerosis (RMS), its first indication, if approved, in 2027. This GMP approval is also mutually recognized by the EU. Ehud Marom, Chairman and Chief Executive Officer, Mapi Pharma, said, “We are very excited to share these positive results for GA Depot in the treatment of PPMS, where there is a significant unmet medical need. The new clinical results we are sharing this week at ACTRIMS demonstrate that GA Depot can significantly impact disease progression. We believe this product, if approved, has the potential to transform the treatment landscape for PPMS, and we look forward to further evaluating GA Depot in the clinic for this indication." The Phase II data in PPMS will be featured in an e-poster at ACTRIMS Forum 2026, as Poster Number: V495, Poster Session 2. A copy of the abstract can be viewed online here. Company management will be available for one-on-one meetings during the conference to discuss potential joint development collaborations. Interested parties should contact Mapi directly. Mapi has partnered with Viatris under an exclusive global license agreement to commercialize GA Depot for RMS. This was an open-label Phase IIa clinical trial that enrolled 30 patients with PPMS, treated with 25 mg (n = 10) or 40 mg (n = 20) IM GA Depot for up to 3 years. The results showed that overall disability remained stable over time, with mean EDSS scores improving slightly from 5.1 at baseline to 4.5 at three years. All patients but one did not experience confirmed disability progression (CDP) over 12 weeks, resulting in a disability progression free rate of 96.6%. Most patients also maintained stable physical function, with 89.7% remaining stable on the 9-Hole Peg Test and 79.3% on the Timed 25-Foot Walk. Sixty nine percent of patients showed no evidence of progression (NEP), with similar rates observed in both dose groups. Treatment with GA Depot was generally well tolerated. Most adverse events (81.6%) were mild (most common were injection site reactions, asthenia, fever). AEs and ISRs rates were numerically lower with 25 mg than with 40 mg. No unexpected AEs were reported. Mapi Pharma (Mapi) is a clinical stage pharmaceutical company, engaged in development of high barrier-to-entry and high added-value life cycle management ("LCM") products and AB Rated Depot injectable products that target large markets that include complex active pharmaceutical ingredients ("APIs") and formulations. Mapi’s lead product is GA Depot which is partnered with Viatris (NASDAQ: VTRS) in an agreement under which Viatris was granted an exclusive license to commercialize the GA Depot injection product for Relapsing Forms of Multiple Sclerosis (RMS). Following successful Phase 3 results GA Depot is currently under FDA & EU review. Mapi is developing depot long-acting injections for anti-psychotic and diabetes medical indications. The Company is also marketing its own generic versions of Fingolimod (Gilenya®) and Apremilast (Otezla®) in specific geographic markets. Mapi's portfolio also includes a leading development of Depot drugs for Schizophrenia, GLP-1 for diabetes, weight loss, with innovative intellectual property. Mapi is built on strong chemical and pharmaceutical R&D and clinical development capabilities and a deep understanding of the global market and of regulatory needs. Mapi is a global company with an API production and aseptic depot manufacturing and a Fill & Finish for injectable Finished Dosage Forms. Mapi has strong IP positions, numerous granted patent applications for APIs and formulations. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultLicense out/in

100 Deals associated with Glatiramer Acetate

External Link

KEGG	Wiki	ATC	Drug Bank
D04318	Glatiramer Acetate	L03AX13	DB05259

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Multiple Sclerosis	United States	Teva Pharmaceuticals USA, Inc.	28 Jan 2014
Multiple Sclerosis, Relapsing-Remitting	United States	Teva Pharmaceuticals USA, Inc.	20 Dec 1996

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Multiple sclerosis relapse	Phase 3	United States	Mapi-Pharma Ltd.	19 Sep 2019
Multiple sclerosis relapse	Phase 3	Belarus	Mapi-Pharma Ltd.	19 Sep 2019
Multiple sclerosis relapse	Phase 3	Bosnia and Herzegovina	Mapi-Pharma Ltd.	19 Sep 2019
Multiple sclerosis relapse	Phase 3	Bulgaria	Mapi-Pharma Ltd.	19 Sep 2019
Multiple sclerosis relapse	Phase 3	Estonia	Mapi-Pharma Ltd.	19 Sep 2019
Multiple sclerosis relapse	Phase 3	Israel	Mapi-Pharma Ltd.	19 Sep 2019
Multiple sclerosis relapse	Phase 3	Moldova	Mapi-Pharma Ltd.	19 Sep 2019
Multiple sclerosis relapse	Phase 3	Russia	Mapi-Pharma Ltd.	19 Sep 2019
Multiple sclerosis relapse	Phase 3	Ukraine	Mapi-Pharma Ltd.	19 Sep 2019
Rhabdomyosarcoma	Phase 3	United States	Mapi-Pharma Ltd.	19 Sep 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


P8-6.018 (AAN2024)	Phase 3	Multiple sclerosis relapse	-	GA Depot	fcxmgjptvr(pnolzeragd) = meosuizrls njhiwfcrin (aliamkvnnu ) View more	Positive	09 Apr 2024
				Copaxone	fcxmgjptvr(pnolzeragd) = rwkgtlbotx njhiwfcrin (aliamkvnnu ) View more
S31.010 (AAN2024)	Not Applicable	Multiple Sclerosis	930	Fingolimod	erfasqhbyg(ardhlbnthj) = uuutxgihgf twtilhfihw (vtuaceijub )	Negative	09 Apr 2024
				Natalizumab	erfasqhbyg(ardhlbnthj) = iiupejoehc twtilhfihw (vtuaceijub )
GA Depot, Phase 3 (ACTRIMS2024)	Phase 3	Multiple sclerosis relapse	763	GA Depot	drrgttcizl(rhluomlbzy) = mean percent change 8.34 owwvojzuar (olzdpdxczl )	Positive	29 Feb 2024
Phase III Open Label period (ACTRIMS2024)	Phase 3	-	821	Glatiramer Acetate Depot	ybpwrpjlxu(hmwiibyrlc) = The most frequent TEAEs reported (≥5% of the subjects in any treatment group), irrespective of the relatedness, were ISRs, pyrexia, influenza-like illness, body temperature increase, and headache sdxkuuwesa (okzpdonvyb ) View more	Positive	29 Feb 2024
				Placebo
NCT04121221 (ECTRIMS2023)	Phase 3	Multiple sclerosis relapse	-	GA Depot	smopbswpyn(nbldfioeeg) = ozjfjzpidz pbpamjcyzz (nbdkcjofox ) View more	-	30 Sep 2023
				Copaxone®	smopbswpyn(nbldfioeeg) = rxrmlcgwkj pbpamjcyzz (nbdkcjofox ) View more
AAN2022	Phase 2	Multiple Sclerosis, Relapsing-Remitting anti-GA antibodies	-	GA Depot 80mg	zektthsapz(ulvmmxnuuk) = peujobswtr nxacsaqpjl (mjpgrgmqpe, +/ - 1.13) View more	Positive	03 May 2022
				GA Depot 40mg	zektthsapz(ulvmmxnuuk) = xykkhdbvkq nxacsaqpjl (mjpgrgmqpe, +/ - 1.25) View more
NCT00176592 (BECOME, CTgov)	Phase 4	Multiple Sclerosis \| Multiple Sclerosis, Relapsing-Remitting	75	Betaseron (Betaseron)	satonakmiq(hotjpuafjq) = pjymjihlyu lmbnqavwnc (jsvtljkwpb, 2.76) View more	-	16 Nov 2021
				Copaxone (Copaxone)	satonakmiq(hotjpuafjq) = zhfdsepxax lmbnqavwnc (jsvtljkwpb, 2.46) View more
NCT00326625 (CTgov)	Phase 2	Amyotrophic Lateral Sclerosis	366	Placebo	auoavfmdoe(zjnwnazxzj) = rlhldegcal xizcymdzfa (klreqetcks, 0.058) View more	-	20 Oct 2021
GA Depot phase IIa (ECTRIMS 12020 \| ECTRIMS 22020 \| AAN2020)	Phase 2	Multiple Sclerosis, Primary Progressive	11	GA Depot	aesfbhsrds(laypediani) = stable ylwypfvbhx (kmtdovgrvg ) View more	Positive	07 Dec 2020
NCT00211887 (CombiRx, Pubmed \| Neurology)	Phase 3	Multiple Sclerosis	959	Interferon-beta-1a	hjsbdpurzc(ttwzpiivzi) = After adjustment, anxiety (hazard ratio [HR] 1.25, 95% confidence interval [CI] 1.01-1.55) and dyslipidemia (HR 1.32, 95% CI 1.01-1.72) were associated with an increased hazard of any disease activity, while migraine (HR 0.80, 95% CI 0.67-0.97) was associated with a decreased hazard. mqtamutuyc (sllrzufvrx )	Positive	04 Aug 2020
				Glatiramer acetate

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