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Last update 18 Apr 2026

Cinpanemab

Last update 18 Apr 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Cinpanemab (USAN), Immunoglobulin g1, anti-(human .alpha.-synuclein) (human monoclonal biib054 .gamma.1-chain), disulfide with human monoclonal biib054 .kappa.-chain, dimer, Immunoglobulin g1-lambda, anti-(homo sapiens alpha-synuclein)humanized monoclonal antibody.gamma.1 heavy chain (1-442) (homo sapiens vh (ighv3-25*03 (86%) (ighd)-ighj2*01) (8.10.4) (1-113)-homo sapiens ighg1*03 (ch3(k107>del(443))) (114-442)) (216-213')-

+ [4]

Target

α-synuclein

Action

inhibitors

Mechanism

α-synuclein inhibitors(Synuclein alpha inhibitors)

Therapeutic Areas

Nervous System DiseasesEndocrinology and Metabolic Disease

Active Indication-

Inactive Indication

Parkinson Disease

Originator Organization

Neurimmune Holding AG

Active Organization-

Inactive Organization

Biogen, Inc.

License Organization-

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

Structure/Sequence

Sequence Code 315620518H

Source: *****

Sequence Code 315620519L

Source: *****

Clinical Trials associated with Cinpanemab

NCT03716570

/ TerminatedPhase 1

A Multicenter, Blinded, Placebo-Controlled, Randomized, Single and Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Subjects With Parkinson's Disease

The primary objective of this study is to evaluate the safety and tolerability of a range of single and 13 repeated doses of BIIB054, administered as intravenous (IV) infusion, in Japanese participants with Parkinson's disease (PD). The secondary objectives are to evaluate the immunogenicity, and serum pharmacokinetics (PK) profile of BIIB054 after single and multiple dose administration.

Start Date12 Mar 2019

Sponsor / Collaborator

Biogen, Inc.

NCT03318523

/ TerminatedPhase 2

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, With an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects With Parkinson's Disease

The primary objective of the study is to evaluate the clinical efficacy of BIIB054 via dose response using the change from baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score.
The secondary objectives of the study are to evaluate the dose-related safety of BIIB054, to evaluate the clinical efficacy of BIIB054 via MDS-UPDRS total score, to assess the pharmacokinetic (PK) profile of BIIB054, to evaluate the clinical efficacy of BIIB054 based on MDS-UPDRS subparts, to evaluate the pharmacodynamic effects of BIIB054 on the integrity of nigrostriatal dopaminergic nerve terminals and to evaluate the immunogenicity of BIIB054.

Start Date10 Jan 2018

Sponsor / Collaborator

Biogen, Inc.

NCT02459886

/ CompletedPhase 1

A Phase 1 Randomized, Double-Blinded, Placebo-Controlled Single-Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB054 in Healthy Subjects and Subjects With Early Parkinson's Disease

The primary objective of the study is to evaluate the safety and tolerability of a range of single BIIB054 doses, administered as a single intravenous (IV) infusion, in healthy participants and participants with early Parkinson's disease (PD). Secondary objectives of the study are to assess the serum pharmacokinetics (PK) profile of BIIB054 after single-dose administration and to evaluate the immunogenicity of BIIB054 after single-dose administration.

Start Date01 Jul 2015

Sponsor / Collaborator

Biogen, Inc.

100 Clinical Results associated with Cinpanemab

100 Translational Medicine associated with Cinpanemab

100 Patents (Medical) associated with Cinpanemab

Literatures (Medical) associated with Cinpanemab

01 Apr 2026·CURRENT OPINION IN NEUROBIOLOGY

The challenges of experimental pharmacology in identifying novel treatments for Parkinson's disease

Review

Author: Huot, Philippe ; Teil, Margaux

An important part of the field of experimental pharmacology encompasses the study of the effects of molecules in animals. In the case of Parkinson's disease (PD), animal models have played an invaluable role in refining our understanding of the disease, in characterizing the effect of new compounds on the illness, and in bringing new treatments to the clinic. Indeed, it is now hardly conceivable that a drug would be tested in humans if several parameters pertaining to safety, toxicology, efficacy, etc. had not previously been evaluated in animal models. Quite unfortunately, efficacy in experimental models of PD does not necessarily guarantee positive clinical outcomes. In this article, which primarily focusses on the past five years, we review drugs that entered clinical trials for the treatment of levodopa-induced dyskinesia, parkinsonism, disease modification, and had previously been assessed in animal models of PD. The drugs discussed are buspirone, JM-010, befiradol, mesdopetam, foliglurax, dipraglurant, tavapadon, prasinezumab, cinpanemab, nilotinib, minzasolmin, exenatide, NLY01, liraglutide, lixisenatide, and semaglutide. For each molecule, we examine how previous preclinical studies succeeded or failed in predicting efficacy in clinical trials and discuss possible ways to optimize animal-model design and selection to maximize the probability of translational success.

01 Mar 2026·JOURNAL OF THE NEUROLOGICAL SCIENCES

α-synuclein monoclonal antibodies in Parkinson's disease: A failed promise or unmet potential?

Review

Author: Mandour, Youssef ; Messak, Mark ; Altalab, Gergis ; Shaker, Omar ; Khattab, Youssef A ; Abdelmageed, Ahmed

BACKGROUND:

Monoclonal antibodies (mAbs) have shown disappointing results in targeting α-synuclein (α-Syn) aggregates in PD, leading us to question whether this therapeutic approach is fundamentally flawed or unrealized potential awaiting better application. This review aims to assess the current evidence, identify key challenges hindering this therapeutic approach, and highlight priorities for future research.

METHODS:

A narrative review of the literature was conducted focusing on available evidence with respect to safety, efficacy, pharmacokinetics, CNS exposure, peripheral and central target engagement, emerging biomarkers and PET scan imaging tracers, and lessons from immunotherapy development in Alzheimer's disease.

FINDINGS:

Five RCTs, three phase-I and two phase-II trials, testing three different forms of mAb (n = 786) were identified. All studies showed that mAbs were generally safe. They demonstrated low but measurable CSF mAb concentration (CSF:Serum = 0.2-0.5%) with limited evidence regarding central target engagement. Phase-II trials failed to meet their primary efficacy endpoints and showed no significant slowing of disease progression (Cinpanemab 250 mg P-value = 0.7, 1250 mg P-value = 0.78, 3500 mg P-value = 0.7; Prasinezumab 1500 mg P-value = 0.24, 4500 mg P-value = 0.72). These disappointing results are attributed to several factors, including late timing of intervention, poor BBB permeability, heterogeneity in α-Syn pathology, not using sensitive tools to detect central target engagement and Delayed PET scan tracers' development.

CONCLUSION:

Although there is strong preclinical evidence supporting the efficacy of mAb in PD, several limitations prevent this from translating into tangible clinical benefit. These limitations do not necessarily indicate a fundamental flaw in the therapeutic concept, but they do highlight the urgent need for future research to prioritize addressing these limitations.

01 Dec 2025·Alzheimers & Dementia

Translational cognitive biomarkers for preclinical drug testing in neurodegenerative diseases

Article

Author: Prado, Marco AM ; Cowan, Matthew ; Bussey, Timothy J ; Evangelista, Czarina ; Fon, Edward A ; Menon, Ravi S. ; Eed, Amr ; Sharma, Sahil ; Novikov, Vladislav ; Durcan, Thomas M. ; Sandoval, Rodrigo ; Saksida, Lisa M ; Tabatabaei, Mohammad‐Hossein ; Chakravarty, M. Mallar ; Prado, Vania F ; Chiosis, Gabriela ; Attaran, Anoosha ; Luo, Wen ; Abduldayem, Yasmien ; Shlaifer, Irina ; Yau, Man Ching

Abstract:

Background:

Neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD) are characterized by the accumulation of misfolded proteins, including amyloid‐β, tau, and alpha‐synuclein (a‐Syn). Despite extensive research, no effective disease‐modifying therapies exist. A major barrier to drug development is the poor translatability of animal models and the lack of biomarkers with predictive power for clinical efficacy. Higher‐order cognitive deficits, such as impaired reversal learning, are observed in patients with synucleinopathies, suggesting that cognitive biomarkers could be valuable in preclinical drug testing. This study evaluates whether touchscreen‐based cognitive testing enhances the predictive validity of preclinical drug testing. We assessed PU‐AD, an HSP90 epichaperome disruptor targeting the abnormal chaperone network implicated in protein misfolding disorders, and a mouse version of Cinpanemab, an anti‐a‐Syn antibody that recently failed in clinical trials, despite initial positive results in animal models.

Method:

Hemizygous M83 transgenic mice were intracerebrally injected with preformed fibrils (PFFs) to model synucleinopathy‐related neurodegeneration. Mice underwent cognitive assessment using the Pairwise Visual Discrimination and Reversal (PVD‐R) touchscreen task, a highly translational measure of cognitive flexibility sensitive to a‐Syn toxicity. PU‐AD and Cinpanemab were administered intraperitoneally post‐PFF injection. Drug doses matched previous animal model studies. Motor performance was assessed with grip strength, rotarod, and wire hang tests. MRI was used to detect brain atrophy. Immunohistochemical and biochemical analyses evaluated a‐Syn pathology and neuroinflammation.

Result:

M83/PFF‐injected mice showed significant reversal learning deficits earlier than motor deficits. Pharmacokinetic analysis confirmed PU‐AD reached brain concentrations comparable to those in other models. PU‐AD treatment rescued cognitive and motor impairments, suggesting broad neuroprotective effects. In contrast, Cinpanemab‐treated mice showed no improvements in cognition and preliminary data suggest no improvements in motor symptoms. Ongoing experiments are evaluating pathology and brain atrophy.

Conclusion:

The lack of Cinpanemab efficacy in our pre‐clinical testing pipeline aligns with clinical trial results. The effectiveness of PU‐AD in reducing both cognitive and motor impairments suggests it may have broad therapeutic potential in synucleinopathies. We suggest that touchscreen‐based cognitive testing enhances the predictive validity of preclinical drug evaluation.

News (Medical) associated with Cinpanemab

14 Apr 2021

·www.biospace.com

SciNeuro and Eli Lilly Unite on Antibodies to Defeat Neurological Diseases in China

Under the terms of the deal, SciNeuro is paying Lilly cash upfront as well as various milestone payments and royalties. No financial details were disclosed. Shanghai, China-based SciNeuro Pharmaceuticals and U.S.-based Eli Lilly and Company inked an exclusive license deal to develop and commercialize alpha-synuclein targeted antibody treatments in Greater China, including mainland China, Hong Kong, Macau, and Taiwan. SciNeuro picked up an exclusive license to the antibodies developed by Lilly. Under the terms of the deal, SciNeuro is paying Lilly cash upfront as well as various milestone payments and royalties. No financial details were disclosed. Lilly will hold all rights outside Greater China. Alpha-synuclein is primarily found in neural tissue. Among other things, it is believed to contribute to Parkinson’s disease. “Approximately 3 million elderly people are currently affected by Parkinson’s disease in Greater China, creating a significant disease burden,” said Michael Hutton, vice president, Neurodegeneration Research, at Lilly. “There is a pressing need for new therapeutic options. We are pleased to be collaborating with SciNeuro, a company dedicated to the treatment of serious neurological diseases and focused on development within Greater China, to help address such needs.” SciNeuro launched in December 2020 with a $100 million Series A financing co-led by Lilly Asia Ventures Fund and Arch Venture Partners. The round was joined by Boyu Capital, General Atlantic, Sequoia Capital China, TF Capital and Zoo Capital. As Hutton noted above, the company is focused on diseases of the central nervous system (CNS). The founder and chief executive officer of SciNeuro is Min Li, former professor at Johns Hopkins Medicine who was also senior vice president and Global Head of Neurosciences R&D at GlaxoSmithKline, and also a Venture Partner at Lilly Asia Ventures. The assets they are licensing from Eli Lilly are preclinical, but Min Li and SciNeuro believe they can provide a solid foundation for a first-in-class portfolio with their in-house pipeline. Li indicated that alpha-synuclein in earlier research has an “off-the-charts” connection to neurodegeneration. That said, other companies, such as AbbVie and Voyager, Roche-partnered Prothena and Biogen, have struggled to develop therapies against the protein. Earlier this year, Biogen abandoned BIIB054 (cinpanemab) for Parkinson’s after it failed to “achieve proof-of-concept” in a Phase II study, missing primary and secondary endpoints. Roche and Prothena’s prasinezumab failed to demonstrate superiority to placebo on MDS-UPDRS total score but are continuing development. They are advancing the drug into a Phase IIb trial in early Parkinson’s disease. “We are very encouraged by the results from PASADENA, demonstrating significant slowing of motor progression and improvements on imaging biomarkers consistent with disease modification, as this provides a rich dataset to directly inform and de-risk this next late-stage study,” Gene Kinney, president and chief executive officer of Prothena, stated in October 2020. “Results from the PASADENA study are part of a growing clinical body of evidence suggesting antibodies that optimally target misfolded proteins can result in clinically meaningful benefit. With a growing pipeline of programs based on this scientific approach, Prothena is poised to advance a number of novel therapeutics for devastating disease.” Their initial focus with the Lilly antibodies is focused on Parkinson’s, dementia with Lewy bodies, and multi-system atrophy. In today’s announcement, Li stated, “We are excited to establish this important collaboration with Lilly, an industry leader in neurological diseases. Alpha-synuclein is a promising target for neurodegenerative disease with robust evidence of human genetics and disease pathology, and it aligns well with SciNeuro’s strategic focus.” “Current therapies for Parkinson’s disease provide symptomatic relief, while alpha-synuclein targeted therapies, particularly given the differentiated features of the Lilly program, have the potential to slow or halt disease progression,” Li continued. “They hold significant promise as a new treatment paradigm to improve the quality of life and management of Parkinson’s disease patients.”

Phase 2License out/in

04 Feb 2021

·www.biospace.com

Biogen Ditches Parkinson's Drug After Phase II Study Fails to Show Benefit

Photo courtesy of Biogen. Biogen announced Wednesday morning in its annual results and earnings presentation that its Phase II SPARK study of cinpanemab, a candidate drug for Parkinson’s disease, missed its primary and secondary endpoints. As the therapy “did not achieve proof-of-concept” and failed to provide benefit in this study, the development of the drug has been discontinued. The Phase II SPARK study examined the ability of cinpanemab, an anti-alpha synuclein (syn) monoclonal antibody, to reduce a measure of impairment and disability compared with placebo. Biogen was hopeful that the drug could successfully compete with Roche and Prothena’s syn therapy prasinezumab. “Although we made this determination in February 2021, it was based on conditions that existed as of December 31, 2020,” the Biogen statement said. “As a result, we recognized an impairment charge of approximately $75.4 million during the fourth quarter of 2020 to reduce the fair value of the related in-process research and development (IPR&D) intangible asset to zero.” The company added that it had adjusted the value of its contingent consideration obligation related to the drug, leading to a gain of $51 million in the fourth quarter of last year. Biogen’s cinpanemab was previously acquired from Neurimmune in 2016 and entered early-stage trials for Parkinson’s disease. In 2018, Biogen presented an overview of the design of the SPARK Phase II study, which at the time is the most advanced program in the company’s Parkinson’s disease pipeline. As Biogen tosses out cinpanemab, the company will switch focus to its Alzheimer’s disease drug aducanumab, co-developed with Tokyo-based Eisai. In late January, the U.S. Food and Drug Administration extended the review period for the companies’ Biologic License Application (BLA) for the therapy, which has been shrouded in controversy since its inception. The FDA’s decision on the drug application was expected March 7, but the delay will place the decision on the agency’s shoulders on June 7. “We are committed to working with the FDA as it completes its review of the aducanumab application,” Biogen’s Chief Executive Offer Michel Vounatsos said in a statement. “We want to thank the FDA for its continued diligence during the review.” Both Biogen and Eisai announced in March 2019 that they were discontinuing their global Phase III clinical trials ENGAGE and EMERGE, both of which were studying aducanumab in patients with mild cognitive impairment for Alzheimer’s and mild Alzheimer’s dementia. In addition, the companies said they were discontinuing their EVOLVE Phase II trial as well as the long-term extension of the PRIME Phase Ib study, after an independent data monitoring committee said these studies were unlikely to reach the primary endpoints. Fast-forward to October 2019, Biogen and Eisai said they still planned to seek regulatory approval for aducanumab, as the Phase III EMERGE trial did indeed meet its primary endpoint of significant reduction in clinical decline. The findings from this study were presented by Biogen at a conference in December, but the overall data were met with some outside skepticism. Despite this skepticism, the data appeared robust enough for the companies to file for a BLA. “Alzheimer’s disease remains one of the greatest public health challenges of our time,” said Vounatsos at the time. “The aducanumab BLA is the first filing for FDA approval of a treatment that addresses the clinical decline associated with this devastating condition, as well as the pathology of the disease. We are committed to driving progress for the Alzheimer’s disease community and look forward to the FDA’s review of our filing.” Most Read Today

CollaborateAntibodyLicense out/in

03 Feb 2021

·www.biospace.com

Biogen Ditches Parkinson’s Drug After Phase II Study Fails to Show Benefit

Biogen is planning to cut its Alzheimer’s drug Adu As the therapy “did not achieve proof-of-concept” and failed to provide benefit in this study, the development of the drug has been discontinued. Photo courtesy of Biogen. Biogen announced Wednesday morning in its annual results and earnings presentation that its Phase II SPARK study of cinpanemab, a candidate drug for Parkinson’s disease, missed its primary and secondary endpoints. As the therapy “did not achieve proof-of-concept” and failed to provide benefit in this study, the development of the drug has been discontinued. The Phase II SPARK study examined the ability of cinpanemab, an anti-alpha synuclein (syn) monoclonal antibody, to reduce a measure of impairment and disability compared with placebo. Biogen was hopeful that the drug could successfully compete with Roche and Prothena’s syn therapy prasinezumab . “Although we made this determination in February 2021, it was based on conditions that existed as of December 31, 2020,” the Biogen statement said. “As a result, we recognized an impairment charge of approximately $75.4 million during the fourth quarter of 2020 to reduce the fair value of the related in-process research and development (IPR&D) intangible asset to zero.” The company added that it had adjusted the value of its contingent consideration obligation related to the drug, leading to a gain of $51 million in the fourth quarter of last year. Biogen’s cinpanemab was previously acquired from Neurimmune in 2016 and entered early-stage trials for Parkinson’s disease. In 2018, Biogen presented an overview of the design of the SPARK Phase II study, which at the time is the most advanced program in the company’s Parkinson’s disease pipeline. As Biogen tosses out cinpanemab, the company will switch focus to its Alzheimer’s disease drug aducanumab, co-developed with Tokyo-based Eisai . In late January, the U.S. Food and Drug Administration extended the review period for the companies’ Biologic License Application (BLA) for the therapy, which has been shrouded in controversy since its inception. The FDA’s decision on the drug application was expected March 7, but the delay will place the decision on the agency’s shoulders on June 7. “We are committed to working with the FDA as it completes its review of the aducanumab application,” Biogen’s Chief Executive Offer Michel Vounatsos said in a statement . “We want to thank the FDA for its continued diligence during the review.” Both Biogen and Eisai announced in March 2019 that they were discontinuing their global Phase III clinical trials ENGAGE and EMERGE, both of which were studying aducanumab in patients with mild cognitive impairment for Alzheimer’s and mild Alzheimer’s dementia. In addition, the companies said they were discontinuing their EVOLVE Phase II trial as well as the long-term extension of the PRIME Phase Ib study, after an independent data monitoring committee said these studies were unlikely to reach the primary endpoints. Fast-forward to October 2019, Biogen and Eisai said they still planned to seek regulatory approval for aducanumab, as the Phase III EMERGE trial did indeed meet its primary endpoint of significant reduction in clinical decline. The findings from this study were presented by Biogen at a conference in December, but the overall data were met with some outside skepticism . Despite this skepticism , the data appeared robust enough for the companies to a BLA. “Alzheimer’s disease remains one of the greatest public health challenges of our time,” said Vounatsos at the time. “The aducanumab BLA is the first filing for FDA approval of a treatment that addresses the clinical decline associated with this devastating condition, as well as the pathology of the disease. We are committed to driving progress for the Alzheimer’s disease community and look forward to the FDA’s review of our filing.”

Phase 2Phase 3AcquisitionClinical Trial Failure

100 Deals associated with Cinpanemab

External Link

KEGG	Wiki	ATC	Drug Bank
D11467	-	-	DB16127

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Parkinson Disease	Phase 2	United States	Biogen, Inc.	10 Jan 2018
Parkinson Disease	Phase 2	Austria	Biogen, Inc.	10 Jan 2018
Parkinson Disease	Phase 2	Canada	Biogen, Inc.	10 Jan 2018
Parkinson Disease	Phase 2	France	Biogen, Inc.	10 Jan 2018
Parkinson Disease	Phase 2	Germany	Biogen, Inc.	10 Jan 2018
Parkinson Disease	Phase 2	Israel	Biogen, Inc.	10 Jan 2018
Parkinson Disease	Phase 2	Italy	Biogen, Inc.	10 Jan 2018
Parkinson Disease	Phase 2	Spain	Biogen, Inc.	10 Jan 2018
Parkinson Disease	Phase 2	United Kingdom	Biogen, Inc.	10 Jan 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03318523 (SPARK, Pubmed \| BMC Neurol)	Phase 2	Parkinson Disease DaT-SPECT	482	Cinpanemab	rthlyspile(mcwvbrqqtz) = tnijclyjrg ytdrxjfefq (aqavmdurnm )	-	01 Dec 2021

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