Assessment of Safety and Feasibility of Exablate Blood-Brain Barrier Disruption for the Treatment of Patients with with Mild Cognitive Impairment (MCI) or Mild Alzheimer's Disease (AD) Undergoing Standard of Care Monoclonal Antibody (mAb) Therapy

The purpose of this study is to assess the safety and feasibility of administering standard of care monoclonal antibody (mAb) infusion therapy in combination with opening the blood-brain barrier with the Exablate Model 4000 Type 2 device in patients with mild Alzheimer's disease (AD) or mild cognitive impairment (MCI).

Start Date14 Jul 2022

Sponsor / Collaborator

West Virginia University

[+1]

NCT05310071

/ TerminatedPhase 3

A Phase 3b/4 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Verify the Clinical Benefit of Aducanumab (BIIB037) in Participants With Alzheimer's Disease

The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score as compared with placebo in participants with early Alzheimer's disease.

Start Date02 Jun 2022

Sponsor / Collaborator

Biogen, Inc.

100 Clinical Results associated with Aducanumab-avwa

100 Translational Medicine associated with Aducanumab-avwa

100 Patents (Medical) associated with Aducanumab-avwa

576

Literatures (Medical) associated with Aducanumab-avwa

14 Apr 2025·Reviews on Recent Clinical Trials

The Importance of Vaccines in Preventing Impending Alzheimer’s Epidemic

Article

Author: Tripathi, Siddhant ; Kumar, Dileep ; Sharma, Yashika

Abstract:The use of antibodies to neutralize cytotoxic soluble amyloid-β aggregates rather than remove plaque has raised cautious hope since the monoclonal antibody BAN2401 seems to halt the course of prodromal Alzheimer's Disease (AD). By immobilizing cytotoxic amyloid-β, rather than the causative factor, plaques can help prevent Alzheimer's disease. A preventive immunity against Alzheimer's disease is shown by natural antibodies against cytotoxic amyloid-β. Vaccines should include adjuvants that promote anti-inflammatory Th2 immunity and immunogens that guard against different cytotoxic amyloid-β conformers to prevent or delay the onsetof Alzheimer's disease. The lack of long-term protection with monoclonal antibodies that neutralize single conformers, such as aducanumab, may be due to amyloid-β pleomorphism. In this scenario, novel cytotoxic conformers might evade neutralization by monoclonal antibodies that were previously successful. A vaccine's ability to elicit a polarized Th2 immunity would depend on both priming and the simultaneous delivery of immunogen to dendritic cells. In addition to neutralizing antibodies against neurotoxic amyloid-β oligomers, an immune response may also release anti-inflammatory cytokines, which can help prevent inflammation that exacerbates Alzheimer's disease. Vaccines would be significantly more successful in preventing Alzheimer's disease than treating it because of age-related immunological decrease. Since both amyloid-β and tau contribute to pathological hyperphosphorylation and work in tandem to cause Alzheimer's disease, preventive vaccinations against both should be taken into consideration. Given their affordability and simplicity, vaccines may be the only way to stop the looming Alzheimer's pandemic in many nations.

03 Apr 2025·Expert Opinion on Drug Safety

Mining and analysis of adverse events associated with aducanumab: a real-world study using FDA Adverse Event Reporting System database

Article

Author: Qi, Yiming ; Zheng, Junxian ; Jiang, Cheng ; Wu, Shuangshuang

BACKGROUNDAducanumab, a monoclonal antibody, received approval for the treatment of Alzheimer's disease in 2021. However, it remains controversial over the security of this drug. In this study, aducanumab-related adverse events (AEs) were evaluated through data mining based on the FDA Adverse Event Reporting System (FAERS) database.RESEARCH DESIGN AND METHODSThe AE reports induced by aducanumab as the primary suspected drug were extracted from the FAERS database. The clinical characteristics of aducanumab-associated reports were analyzed. The potential new AE signals of aducanumab were explored using four disproportionality analysis methods. Furthermore, the difference in aducanumab-associated AE signals was investigated concerning sex, age, weight, dose, onset time, and continent.RESULTSIn total, 328 reports and 793 AEs associated with aducanumab were identified. Six new AEs were identified. No significant sex and weight difference in aducanumab-related signals was found. Notably, nervous system disorders, especially 'amyloid related imaging abnormality-edema/effusion' and 'amyloid related imaging abnormality-microhaemorrhages and haemosiderin deposits,' were more frequently to be reported within 121-240 days, particularly in Europe.CONCLUSIONSThis study contributes real-world evidence regarding the safety of aducanumab.

03 Apr 2025·Brain

Tau, synapse loss and gliosis progress in an Alzheimer’s mouse model after amyloid-β immunotherapy

Article

Author: Hyman, Bradley T ; Khasnavis, Anita ; Mate de Gerando, Anastasie ; Bussiere, Thierry ; Welikovitch, Lindsay A ; Chibnik, Lori B ; Buée, Luc ; Bhavsar, Harshil ; Meltzer, Jonah C

AbstractPreclinical studies assessing drugs for Alzheimer’s disease (AD) are conducted in animal models that usually display only one neuropathological feature of AD, whereas patients present with a complex combination of comorbidities and neuropathologies. Importantly, it is well established that amyloid-β (Aβ) plaque and tau tangle accumulation interact in a phase-dependent manner, making it difficult to predict how targeting one might influence the other, as well as downstream degeneration.We developed a transgenic mouse model, APP/PS1xTau22, with progressive cortical Aβ deposition and hippocampal tau neurofibrillary inclusions, to investigate how both neuropathologies act jointly to bring about neural degeneration, synapse loss and glial phenotypes. We then assessed whether applying murine chimeric aducanumab, an anti-amyloid immunotherapy, could impact the synergistic relationship between amyloid and tau.Drug treatment resulted in a ∼70% reduction in Aβ deposition in hippocampal and cortical areas and produced a robust peri-plaque microglial and astrocytic response. Removing amyloid from the brain did not reverse or slow tau pathology or alter synapse loss.Our findings suggest that, once the interaction between amyloid and tau is set in motion, reducing plaque burden by Aβ immunotherapy may stimulate glial responses, but is insufficient to curb degenerative phenotypes in this model.

857

News (Medical) associated with Aducanumab-avwa

01 May 2025

·www.pharmaceutical-technology.com

Biogen’s Q1 revenue soars past estimates as rare disease pivot pays off

Spinal muscular atrophy treatment Spinraza (nusinersen) became Biogen’s best-selling drug in Q1 2025. Image credit: Shutterstock/ Tada Images. Biogen has unveiled Q1 2025 revenues above estimates, spurred by strong sales of rare disease assets amid a sales dropoff from its multiple sclerosis business. Quarterly revenues for the neurological disease drugmaker were $2.43bn, above analyst group William Blair’s estimates of $2.3bn. The Q1 sales performance represents a 6% increase compared to the same period in 2024, with Biogen ramping up commercial duties for existing drugs and buying assets during that time. One of those assets is Skyclarys, a drug picked up in a $7.3bn acquisition of Reata Pharmaceuticals in September 2023. The treatment for the neurodegenerative disorder Friedreich’s ataxia generated revenue of $124m in Q1, a value that had already taken into account the impact seen in US sales due to Medicare discount dynamics. Approved in the US, Europe, and UK, amongst others, Skyclarys has a high growth ceiling. GlobalData’s Pharma Intelligence Centre forecasts sales of $1.3bn by 2031. GlobalData is the parent company of Pharmaceutical Technology . Skyclarys is one of the drugs spurring a change of the guard in Biogen’s pipeline. The company is well known for its host of multiple sclerosis treatments, such as Vumerity (diroximel fumarate), Tysabri (natalizumab), and Avonex (interferon beta-1a). But, sales for these treatments have declined over the years as biosimilars entered the market. The company’s multiple sclerosis business shrank 11% in Q1 2025 compared to the same period last year. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence “Biogen is really, a tale of two companies in my view. There’s one company which has been a multiple sclerosis company, and that portfolio, as you all know, has been gradually declining,” said Biogen’s CEO Chris Vibacher in a Q1 earnings call. “But there’s a new Biogen emerging. And when I look at the rare disease business […] we actually have a commercial portfolio that we’re actively promoting that’s now gotten to be about 45% of our product revenue. And those products mostly have a very long runway to continue to grow,” Vibacher added. Alongside Skyclarys, Biogen’s rare disease business is headed by spinal muscular atrophy treatment Spinraza (nusinersen). Spinraza generated global Q1 2025 sales of $423.9m, up from $341.3m in Q1 2024. This increase, coupled with the decline of Tysabri, meant Spinraza was Biogen’s best-selling drug in Q1 2025. Leqembi’s “modest growth” Another key part of Biogen’s business model is its Alzheimer’s segment, now solely headed by Leqembi (lecanemab) after the company discontinued Aduhelm (aducanumab) at the start of 2024. Biogen splits revenue from Leqembi with co-developer Eisai equally, the latter reporting Q1 sales of $96m for the drug. The US, where Leqembi got a full approval in July 2023, accounted for $52m of those sales. Biogen has already secured key milestones for Leqembi this year. In January, the US Food and Drug Administration (FDA) approved maintenance dosing of Leqembi, a move expected to expand its market share. Then in April, the Leqembi was authorised for use in the European Union (EU). Biogen said the Q1 sales for Leqembi represented “continued sequential growth.” William Blair analyst Myles R. Minter said in a research note that: “Skyclarys had a strong quarter, but the commercial focus remains on Leqembi, which has seen only modest growth, in our view.” In the mergers and acquisitions space, Biogen failed a $469m takeover bid of Sage Therapeutics in January.

Drug ApprovalAcquisitionBiosimilar

28 Mar 2025

·endpts.com

European regulator rejects Lilly's Alzheimer’s drug over potentially fatal side effects

Eli Lilly’s Alzheimer’s drug Kisunla has failed to get support from the European Medicines Agency over serious side effects and three patient deaths. The agency’s human medicines committee (CHMP) recommended that the European Commission reject Lilly’s donanemab, branded as Kisunla, saying its benefits don’t outweigh the risks of potential swelling and bleeding in the brain, called amyloid‑related imaging abnormalities (ARIA). The opinion marks another blow for anti-amyloid treatments in Europe. CHMP only recently gave the go-ahead for Eisai and Biogen’s Leqembi in November, after previously rejecting the drug over safety issues in July 2024. The regulator rejected Biogen’s Aduhelm in 2021 , leading the company to withdraw its application a year later. The EC has the final say over new drug approvals, but it normally follows CHMP’s recommendations. CHMP has been wary of recommending Alzheimer’s drugs that risk the development of ARIAs. Kisunla has higher rates of ARIA compared to Leqembi, according to William Blair analysts. Both Aduhelm and Leqembi are FDA-approved, and Lilly won approval for Kisunla in the US last July. ARIAs were recorded in 36.8% of people who took Kisunla compared with 14.9% who received the placebo, which resulted in three patient deaths, CHMP said in its latest opinion. Lilly said Friday it was “disappointed” by the CHMP’s decision and will look for a “re-examination” from the agency. The company has 15 days to submit for another review process. Kisunla is estimated to pull in around $2 billion in global sales in 2030, according to GlobalData analysts. Lilly’s application to CHMP used data from 1,736 patients enrolled in a Phase 3 study called TRAILBLAZER-ALZ 2, which was used to secure approvals in other markets including the UK , Japan , and China. Kisunla is given to a patient through an infusion drip once every four weeks and contains a monoclonal antibody that attaches to plaques that are formed in the brain in patients with Alzheimer’s disease.

Phase 3Drug ApprovalAccelerated Approval

20 Feb 2025

·www.prnewswire.com

The Alzheimer's Drug Discovery Foundation Announces Daniel M. Skovronsky, MD, PhD, of Eli Lilly & Company, as Recipient of Prestigious 2025 Melvin R. Goodes Prize

Skovronsky will be recognized for his extraordinary work with the Amyvid PET scan, the first FDA-approved diagnostic test for Alzheimer's.The Goodes Prize – referred to the Nobel Prize of Alzheimer's research – honors scientists making extraordinary and lasting contributions to the Alzheimer's field. NEW YORK, Feb. 20, 2025 /PRNewswire/ -- The Alzheimer's Drug Discovery Foundation (ADDF) will present its 2025 Melvin R. Goodes Prize to Daniel M. Skovronsky, MD, PhD, Chief Scientific Officer, Lilly, and President, Lilly Research Labs, at the Inaugural ADDF Scientific Summit on Wednesday, March 5th. Skovronsky will be recognized for his groundbreaking work to develop critical diagnostic tests for Alzheimer's in addition to his leadership in developing and commercializing Kisunla, one of the first disease-modifying therapies for Alzheimer's patients. Continue Reading Daniel M. Skovronsky, MD, PhD, of Eli Lilly & Company, announced as the 2025 Melvin R. Goodes Prize The game-changing diagnostics developed with Skovronsky's help include the Amyvid PET scan, the first FDA-approved diagnostic test for Alzheimer's; the Tauvid PET scan, the first and only FDA-approved diagnostic for Tau in the brain; and a blood biomarker test for p-tau217 for the early diagnosis of Alzheimer's disease. The Goodes Prize, referred to as the Nobel Prize of Alzheimer's research, is presented annually to a leading scientist to mark exceptional contributions to the Alzheimer's field. This international award was established by the late Melvin R. Goodes to advance critical science aimed at fighting Alzheimer's disease and related dementias. "Dan is the epitome of a Goodes Prize awardee, a leading scientist who has advanced innovative and bold ideas to transform how we diagnose and develop new treatments for Alzheimer's," said Howard Fillit, MD, Co-Founder and Chief Science Officer at the ADDF. "The Goodes Prize emphasizes our ongoing commitment to accelerating drug development for Alzheimer's and honors the legacy of Mel Goodes, a trailblazer in the pharmaceutical industry. We are thrilled to recognize Dan's outstanding work and partnership with the ADDF, which spans more than 20 years. His efforts to develop the Amyvid PET scan made recent Alzheimer's drug approvals possible, including Lilly's Kisunla, and will benefit patients now and for years to come." The Amyvid PET scan, which received early seed funding from the ADDF, is a brain imaging test that helps detect Alzheimer's disease by combining a positron emission tomography (PET) scan and an injection of Amyvid, a radioactive tracer. Amyvid was instrumental in the approval of the first disease-modifying Alzheimer's drugs – Aduhelm in 2021, Leqembi in 2023, and Kisunla in 2024 – providing the biomarker data needed for regulatory approval. "Over the past decade, we have witnessed remarkable advances in Alzheimer's research," said Dr. Daniel Skovronsky, Chief Scientific Officer, Lilly, and President, Lilly Research Labs. "It is my belief that through early detection and early intervention we can someday make Alzheimer's a preventable disease. I am deeply honored to receive the prestigious Goodes Prize award and look forward to joining fellow recipients who are leading the way in developing new treatments for Alzheimer's. The early support from the ADDF for my work, which aimed to revolutionize how we diagnose patients to ensure the right ones were included in our studies, was crucial to advancing the field, and I will always be grateful for that support." The Goodes Prize, which celebrated its 10th anniversary last year in Stockholm with a program featuring Queen Silvia of Sweden and U.S. Ambassador to Sweden Erik Ramanathan, honors scientists who are leading new approaches to developing Alzheimer's therapeutics and diagnostics. "To have pioneering scientists like Dan who have received this award out there in the field, pushing research forward, is truly a gift," said Nancy Goodes, ADDF Board Member. "The breakthroughs being made in the name of the Goodes Prize are the most meaningful legacy for my husband." The 11th annual Goodes Prize will be presented at 6:00 p.m. ET on Wednesday, March 5, 2025 during the inaugural ADDF Scientific Summit. This celebration of Alzheimer's science will be hosted by Dr. Howard Fillit and features a keynote address from Dr. Sanjay Gupta, MD, CNN Chief Medical Correspondent, bestselling author and practicing neurosurgeon. The summit will highlight nine world-renowned scientists and recipients of the Melvin R. Goodes Prize discussing therapeutics, biomarkers, prevention, and what is coming next in the field. Skovronsky will be the latest to join the ranks of these accomplished scientists who have helped bring the biology of aging to the forefront of Alzheimer's research. "The Goodes Prize represents our mission to treat, prevent, and ultimately cure Alzheimer's disease," commented Mark Roithmayr, ADDF Chief Executive Officer. "We support one of the largest and most diverse clinical development portfolios for Alzheimer's disease, and pioneering research, like Dan's, is critical to our goal of driving meaningful innovation and change in drug development." The Melvin R. Goodes Prize for Excellence in Drug Development was established in 2015 in honor of Melvin R. Goodes, former CEO of Warner-Lambert Company, who channeled his unique knowledge of the drug industry into Alzheimer's advocacy after being diagnosed with the disease. The award recognizes individual researchers whose work has significantly advanced our understanding of Alzheimer's, paving the way for potential breakthroughs in treatment and prevention. Previous Goodes Prize recipients have demonstrated tremendous innovation and perseverance in the quest for effective treatment options for Alzheimer's. Internationally lauded as the highest recognition in Alzheimer's research, the Goodes Prize has helped move the field forward by facilitating thought provoking discussions among leading scientists from academia, industry, and philanthropy in pursuit of a future free of Alzheimer's. About The Alzheimer's Drug Discovery Foundation (ADDF) Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF's leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer's PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $370 million to fund 765 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 21 countries. To learn more, please visit: . SOURCE Alzheimer's Drug Discovery Foundation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

100 Deals associated with Aducanumab-avwa

External Link

KEGG	Wiki	ATC	Drug Bank
D10541	Aducanumab-avwa	N07	DB12274

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Alzheimer Disease	United States	Biogen, Inc.	07 Jun 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 1	European Union	Biogen, Inc.	17 Dec 2021
Cognitive Dysfunction	Phase 1	United States	Biogen, Inc.	20 Dec 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05310071 (ENVISION, CTgov)	Phase 3	Alzheimer Disease	1,027	Placebo (Placebo)	jmvwbeospf(kbumlvsvfp) = gjazqnvgsk izzvtzfoaf (eqcefbklxv, jyqkksfmis - zhzqvcqdgo) View more	-	23 Apr 2025
				Aducanumab (Aducanumab)	jmvwbeospf(kbumlvsvfp) = mdjpltpvqb izzvtzfoaf (eqcefbklxv, voyvmpfmom - dtukpbalhd) View more
NCT04241068 (CTgov)	Phase 3	Alzheimer Disease	1,696	Aducanumab	(xdkflvyhny) = tzzeaibuey jrroptugzw (xqsneaaypg, euqwivowmb - lqytvtkzcc) View more	-	21 Feb 2025
NEWS Manual	Not Applicable	Alzheimer Disease	3	聚焦超声+aducanumab	iwjmvcxatv(jsmerttbtf) = 6个月的联合治疗阶段，所有聚焦超声靶向脑区的血脑屏障均有开放，在手术后24-48小时内关闭， cyhlhiqnwg (mszravqpdi ) View more	Positive	04 Jan 2024
				aducanumab (对侧未接受聚焦超声)
TRAILBLAZER-ALZ-4 (AAN2023)	Phase 3	Alzheimer Disease	148	Donanemab	(rketnhvyti) = 62.0% of donanemab-treated and 66.7% of aducanumab-treated participants reported an adverse event (AE), there were no serious AEs due to ARIA in donanemab arm and 1.4% serious AEs (one event) due to ARIA were reported in aducanumab arm. atbhynbnlb (gfidsvzqbk )	-	25 Apr 2023
				Aducanumab
NCT02477800 (ENGAGE, AAIC2022)	Phase 3	Alzheimer Disease ApoE3/3 \| ApoE4/4	-	Aducanumab (Patient 1)	msesxcppcq(okovnfzmey) = fvaboboqfl dabaagikpe (fmjoyniknf )	-	20 Dec 2022
				Aducanumab (Patient 2)	msesxcppcq(okovnfzmey) = rmwmntlgvf dabaagikpe (fmjoyniknf )
NCT02484547 \| NCT02477800 (EMERGE and ENGAGE, AAN2022)	Phase 3	apolipoprotein ɛ4	2,192	Aducanumab 10 mg/kg	zpbldphjnu(ztpavnzrdb) = nzeicysenw kfcgfqnnby (xviykrdphs ) View more	Positive	03 May 2022
				Placebo	bnesqykkrl(bspkqsuxvj) = zexwafvutm qpmkocujbx (hylwxnmxnz )
EMERGE and ENGAGE (AAIC2021)	Not Applicable	apolipoprotein ε4	3,285	Aducanumab	tvgmsxlmpa(dmjftoesxf) = rdgzwgpjuw dvcaylnqru (nsjbqjdxsl ) View more	-	31 Dec 2021
NCT03639987 (EVOLVE, CTgov)	Phase 2	Alzheimer Disease \| Cognitive Dysfunction	52	Placebo+Aducanumab (Group 1)	bwawxzkebv(aqnfczhoiw) = mkkafaluqs bkrhxpkjhv (pgxtkdootn, vizndhmtjl - rayxwhtoid) View more	-	16 Sep 2021
				Aducanumab (Group 2)	bwawxzkebv(aqnfczhoiw) = vcklgpzvru bkrhxpkjhv (pgxtkdootn, jgnrcdvqik - jjocjtogfx) View more
NCT02484547 (221AD302 \| EMERGE, CTgov)	Phase 3	Alzheimer Disease	1,643	Placebo (Placebo (PC Period))	hvbgleupqe(zsjlbqjhfu) = fajgcggtom woylgkamrp (rgaoczybqg, yxcntybgzg - seizoqwknd) View more	-	02 Sep 2021
				BIIB037 (BIIB037 Low Dose (PC Period))	hvbgleupqe(zsjlbqjhfu) = fszsvrahxr woylgkamrp (rgaoczybqg, wisvtflaka - wftdcqjfnt) View more
NCT02477800 (221AD301 \| ENGAGE, CTgov)	Phase 3	Alzheimer Disease	1,653	Placebo (Placebo (PC Period))	cqpzdsdrzt(jbvyylvqgk) = qzliuksupd jcavtizvye (zoticksrvn, ibxuhgulpu - ursbxrztdd) View more	-	02 Sep 2021
				BIIB037 (BIIB037 Low Dose (PC Period))	cqpzdsdrzt(jbvyylvqgk) = jyafupqpzi jcavtizvye (zoticksrvn, iskqzkynqc - uuiiyvglxw) View more

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