Precision Medicine for Chronic Myelomonocytic Leukaemia in Adults: A phase II Trial Studying the Efficacy of Lenzilumab and High Dose Ascorbate with Azacitidine Based on Molecular Profiling.

Start Date28 Sep 2021

Sponsor / Collaborator

South Australian Health & Medical Research Institute Ltd.

NCT04583969 / CompletedPhase 2IIT

A Multicenter Platform Trial of Putative Therapeutics for the Treatment of COVID-19 in Hospitalized Adults

This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints in hospitalized adults diagnosed with Coronavirus Disease 2019 (COVID-19). Big Effect Trial (BET) is a proof-of-concept study with the intent of identifying promising treatments to enter a more definitive study. The study will be conducted in up to 70 domestic sites and 5 international sites. The study will compare different investigational therapeutic agents to a common control arm and determine which have relatively large effects. In order to maintain the double blind, each intervention will have a matched placebo. However, the control arm will be shared between interventions and may include participants receiving the matched placebo for a different intervention.
The goal is not to determine clear statistical significance for an intervention, but rather to determine which products have clinical data suggestive of efficacy and should be moved quickly into larger studies. Estimates produced from BET will provide an improved basis for designing the larger trial, in terms of sample size and endpoint selection. Products with little indication of efficacy will be dropped on the basis of interim evaluations. In addition, some interventions may be discontinued on the basis of interim futility or efficacy analyses.
One or more interventions may be started at any time. The number of interventions enrolling are programmatic decisions and will be based on the number of sites and the pace of enrollment. At the time of enrollment, subjects will be randomized to receive any one of the active arms they are eligible for or placebo. Approximately 200 (100 treatment and 100 shared placebo) subjects will be assigned to each arm entering the platform and a given site will generally have no more than 3 interventions at once.
The BET-B stage will evaluate the combination of remdesivir with lenzilumab vs remdesivir with a lenzilumab placebo. The primary objective is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in adults hospitalized with COVID-19 according to clinical status (8-point ordinal scale) at Day 8.

Start Date23 Oct 2020

Sponsor / Collaborator

National Institute of Allergy & Infectious Diseases

100 Clinical Results associated with Lenzilumab

100 Translational Medicine associated with Lenzilumab

100 Patents (Medical) associated with Lenzilumab

Literatures (Medical) associated with Lenzilumab

31 Dec 2022·Journal of Medical EconomicsQ4 · MEDICINE

Clinical and economic benefits of lenzilumab plus standard of care compared with standard of care alone for the treatment of hospitalized patients with COVID-19 in the United States from the hospital perspective

Q4 · MEDICINE

Article

Author: Thomas, Kimberly ; Jordan, Edward ; Chappell, Dale ; Pepper, Alicia N. ; Hughes, Avery ; Thompson, Melissa ; Kilcoyne, Adrian ; Amarapala, Miyuru ; Zhou, Allen

AIMSEstimate the clinical and economic benefits of lenzilumab plus standard of care (SOC) compared with SOC alone in the treatment of patients hospitalized with COVID-19 pneumonia from the United States (US) hospital perspective.MATERIALS AND METHODSA per-patient cost calculator was developed to report the clinical and economic benefits associated with adding lenzilumab to SOC in newly hospitalized COVID-19 patients over 28 days. Clinical inputs were based on the LIVE-AIR trial, including failure to achieve survival without ventilation (SWOV), mortality, time to recovery, intensive care unit (ICU) admission, and invasive mechanical ventilation (IMV) use. Base case costs included the anticipated list price of lenzilumab, drug administration, and hospital resource costs based on the level of care required. A scenario analysis examined projected one-year rehospitalization costs.RESULTSIn the base case and all scenarios, lenzilumab plus SOC improved all specified clinical outcomes relative to SOC alone. Lenzilumab plus SOC resulted in estimated cost savings of $3,190 per patient in a population aged <85 years with C-reactive protein (CRP) levels <150 mg/L and receiving remdesivir (base case). Per-patient cost savings were observed in the following scenarios: (1) aged <85 years with CRP <150 mg/L, with or without remdesivir ($1,858); (2) Black and African American patients with CRP <150 mg/L ($13,154); and (3) Black and African American patients from the full population, regardless of CRP level ($2,763). In the full modified intent-to-treat population, an additional cost of $4,952 per patient was estimated. When adding rehospitalization costs to the index hospitalization, a total per-patient cost savings of $5,154 was estimated.CONCLUSIONSThe results highlight the clinical benefits for SWOV, ventilator use, time to recovery, mortality, time in ICU, and time on IMV, in addition to an economic benefit from the US hospital perspective associated with adding lenzilumab to SOC for COVID-19 patients.

21 Jul 2022·Nederlands tijdschrift voor geneeskunde

[Current and future therapeutic options for COVID-19].

Article

Author: Nelissen-Vrancken, H Marjorie J M G ; Berger, Marjolein Y ; Kunst, Peter W A ; Olde Rikkert, Marcel G M ; Rosendaal, Frits R ; Bonten, Marc J M ; van Gerven, Joop M A ; Muller, Majon ; Dankers, Marloes

The anti-inflammatory agents dexamethasone (corticosteroid), and tocilizumab and sarilumab (IL6-inhibitors) are effective in the treatment of late COVID-19. Other anti-inflammatory agents, like anakinra (IL1-inhibitor), baricitinib and tofacitinib (JAK-inhibitors) and lenzilumab (GM-CSF-inhibitor) have also shown positive results in late COVID-19. For the treatment of early COVID-19, the inhalation corticosteroid budesonide is regarded as an off-label treatment option. Virus-inhibitors, like remdesivir, molnupiravir and nirmatrelvir/ritonavir decrease the risk of hospitalization and the development of severe COVID-19 by patients with early symptoms. Monoclonal antibodies have shown limited or no efficacy against the omicron-variant of SARS-CoV-2. Fluvoxamine, l-arginine, AT-527 and ensovibep are considered as potential promising new therapies for the treatment of early COVID-19.

01 Apr 2022·Annals of Internal MedicineQ1 · MEDICINE

In inpatients with COVID-19 who need supplemental oxygen, lenzilumab increased ventilation-free survival

Q1 · MEDICINE

Article

Author: Mylonakis, Eleftherios ; Mariano, Vincent J.

SOURCE CITATIONTemesgen Z, Burger CD, Baker J, et al. Lenzilumab in hospitalised patients with COVID-19 pneumonia (LIVE-AIR): a phase 3, randomised, placebo-controlled trial. Lancet Respir Med. 2022;10:237-46. 34863332.

News (Medical) associated with Lenzilumab

12 Feb 2024

·www.fiercebiotech.com

Biotech bankruptcies hit 10-year peak in 2023

In terms of biotech bankruptcies, the new year is starting off bleak. In the first few days of 2024 alone, Humanigen and Athersys both filed for bankruptcy. More biotech companies filed for bankruptcy in 2023 than any year since 2010, underscoring a brutal year defined by layoffs, company closures and pipeline reprioritizations, according to data from S&P Global Market Intelligence. 2023 eclipsed all other years by far, with 18 companies filing for protection compared to eight in 2022, which had previously held the record as the highest bankruptcy year. https://public.flourish.studio/visualisation/16736139/ The year kicked off with Sorrento Therapeutics filing Chapter 11 amid a legal battle with billionaire Patrick Soon-Shiong and his immunotherapy biotech NantCell. The company had $235 million in debt and had run out of options. Sorrento had been developing a generic rival to Bristol Myers Squibb’s Abraxane, which was the subject of the dispute with Soon-Shiong. As of November 2023, Sorrento had laid off its chief financial officer in the final step in the closure process, according to a Securities and Exchange Commission document. For Infinity Pharmaceuticals, an unsuccessful merger with MEI Pharma was the straw that broke the camel’s back. The cancer-focused biotech filed for Chapter 11 bankruptcy on Sept. 29, a move that followed a 75% workforce reduction in July. Infinity had looked for a strategic transaction to keep running trials for eganelisib, a midstage asset being assessed in multiple indications, including urothelial cancer and solid tumors. MEI Pharma appeared to offer the saving Infinity sought until MEI shareholders’ sunk the deal, with 51% of voters opposed to the transaction. OncoSec Medical, which filed in June, was forced to wrap up after a pivotal trial of an interleukin 12-encoding plasmid in combination with Merck & Co.’s Keytruda failed to meet the bar for success in objective response rate. The phase 2b trial was testing the med, called TAVO-EP, in patients with unresectable or metastatic melanoma who had progressed after treatment with an anti-PD-1 checkpoint inhibitor. The company filed for bankruptcy after defaulting on a $2 million loan. https://public.flourish.studio/visualisation/16735813/ Back to court In terms of biotech bankruptcies, the new year is starting off bleak. In the first few days of 2024 alone, Humanigen and Athersys both filed for bankruptcy. The move comes as no surprise for Humanigen, a monoclonal-antibody-focused biotech that had been considering bankruptcy since last summer after talks of a potential reverse merger fell through. The company was on its last leg, with only $3.1 million in the bank last March after its anti-human GM-CSF mAb failed to improve outcomes in hospitalized COVID-19 patients in 2022. This is not the first time Humanigen has gone to the bankruptcy courts. The company, then named KaloBios Pharmaceuticals, also filed in 2015 but managed to reorganize and survive the struggle, according to the S&P data. The company emerged from bankruptcy the following year, thanks to a $14 million equity financing that helped recapitalize the business. Humanigen also picked up rights to a rare disease treatment called benznidazole. The biotech’s name changed to Humanigen in August 2017. But financial troubles again hit the newly named company, forcing the offloading of benznidazole in December 2017 as part of an agreement to exchange loan obligations for equity. Humanigen shifted from rare diseases to immunotherapy and oncology and moved lenzilumab to the center of its pipeline. Lenzilumab never quite found its footing in the clinic, with Humanigen testing it in cancer, COVID-19, graft-versus-host disease and others. A second therapy, the EphA-3-targeted monoclonal antibody ifabotuzumab, was also in development as recently as August 2023. That August pipeline update was the last from Humanigen, and, in January, bankruptcy papers (PDF) were filed. The company now plans to sell off its assets in a bidding process. But before filing the bankruptcy work, Humanigen sold off its biopharma business to Taran Therapeutics, meaning the therapies will go on via a stalking horse bid. Taran picked up a portfolio of monoclonal antibodies, including lenzilumab, ifabotuzumab and HGEN005, for $20 million. The writing was also on the wall for Athersys after the stem cell therapy company suffered a series of clinical setbacks. Ultimately, disappointing phase 3 data for an ischemic stroke cell therapy triggered the biotech to sell off all assets and file for bankruptcy Jan. 5. The healthcare sector as a whole has kicked off the year in third place among bankruptcy filings by sector, according to S&P, behind industrials and consumer discretionary. While the pace of bankruptcies across all sectors declined to start the year, S&P noted that companies are still facing relatively high interest rates and a challenging labor market. Editor's note: Chart data sourced from S&P Global Market Intelligence. Graphics by Gabrielle Masson.

Phase 2ImmunotherapyPhase 3AcquisitionCell Therapy

07 Aug 2023

·www.biospace.com

Humanigen Announces First Participant Dosed in RATinG Trial of Lenzilumab for Early Treatment of Acute Graft Versus Host Disease Following Allogeneic Stem Cell Transplantation

The RATinG (Risk Adapted Therapy in Acute GvHD) is the first trial to explore granulocyte-macrophage colony-stimulating factor (GM-CSF) neutralization for the early treatment of participants with high-risk acute Graft versus Host Disease Planned interim assessment expected in 2024 following treatment of first 20 participants Short Hills, New Jersey--(News - August 7, 2023) - Humanigen, Inc. (OTC Pink: HGEN), a clinical-stage biopharmaceutical company, today announced successful dosing of the first participant in the RATinG trial of lenzilumab for the early treatment of acute Graft versus Host Disease (aGvHD), conducted by IMPACT, a world-class accelerated clinical trial network delivering innovative research for stem cell transplant patients in major centers in the UK. "I am delighted that we have treated our first patient and am grateful to the IMPACT Partnership, Humanigen and to the US MAGIC Consortium for supporting this important study," said Professor Adrian Bloor MA, MB BChir, PhD, FRCP, FRCPath, director of Stem Cell Transplantation, The Christie NHS Foundation Trust. "We anticipate that RATinG will be enrolling patients across 18 IMPACT treatment centers in the UK." The RATinG trial, a Phase 2/3 study, aims to evaluate the efficacy of lenzilumab as an early treatment to improve non-relapse mortality in patients with high risk aGvHD following allogeneic stem cell transplant (HSCT). aGvHD is a serious condition with significant morbidity and mortality that affects 40%-70% of all patients who undergo HSCT.1,2 Mortality from aGvHD is as high as 70%-75% and patients with Grade III aGvHD may not survive more than two years,3 making it one of the leading causes of non-relapse mortality in this situation.2 Lenzilumab is intended to neutralize the immune signalling of the cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF), which may initiate the inflammatory cascade that drives aGvHD.4 Lenzilumab is administered to RATinG participants identified with markers of high-risk aGvHD using the MAGIC criteria. This population has a four-fold higher mortality rate than those identified as low-risk using the same biomarkers.5 The RATinG trial is being conducted in collaboration with IMPACT, the British Society of Blood and Marrow Transplantation, and the University of Birmingham's Cancer Research UK Clinical Trials Unit. "We are excited to support of the use of lenzilumab in a clinical trial that addresses the unmet need of aGvHD and help improve patient outcomes," said Dr. Cameron Durrant, chairman and chief executive officer, Humanigen. About the Risk Adapted Therapy in Acute Graft versus Host Disease (RATinG) Trial The RATinG trial will evaluate lenzilumab in participants who have undergone allogeneic HSCT and been diagnosed with high-risk aGvHD. The trial is proposed to be conducted at up to 18 sites across the UK transplant network in two stages. The first stage of the trial is expected to treat 20 participants with lenzilumab before conducting an interim assessment of safety, efficacy, and feasibility. If an independent data monitoring committee deems the second stage to be feasible, then the trial would progress to its double-blind, randomized (1:1), second stage, which contemplates enrolment of approximately 220 patients. A second interim analysis is planned to assess futility based upon the 28-day response rate to the first infusion in the first 150 evaluable patients. Investigators will assess for aGvHD diagnosis and risk stratification as measured by the Mount Sinai Acute GvHD International Consortium ("MAGIC") biomarkers. Intermediate and high-risk groups will be treated with lenzilumab and steroids in stage 1. In stage 2 they would be randomized to receive lenzilumab and steroids or placebo and steroids. The stage 2 primary endpoint, non-relapse mortality, would be assessed once all participants complete at least 6 months follow up. About Humanigen Humanigen, Inc. (OTC Pink: HGEN) ("Humanigen"), is a clinical-stage biopharmaceutical company focused on developing lenzilumab, a first-in-class antibody that binds to and neutralizes granulocyte-macrophage colony-stimulating factor. Humanigen is developing lenzilumab as a treatment for chronic myelomonocytic leukemia and acute graft versus host disease. Humanigen is also exploring use of lenzilumab to prevent toxicities associated with CAR-T therapy through investigator-initiated trials. Humanigen is also developing an antibody drug conjugate (ADC) utilizing its EphA-3 targeted monoclonal antibody ifabotuzumab ("ifab") for solid tumors. For more information, visit and follow Humanigen on Twitter. About IMPACT IMPACT is a partnership of organizations committed to improving the outcomes of stem cell transplant patients through the delivery of clinical trials across the UK. It is jointly funded by Anthony Nolan, Leukaemia UK and NHS Blood and Transplant. IMPACT aims to ensure patients benefit from scientific advances sooner by making it easier for transplant centers to work together to set up clinical trials, recruit patients and share data. The partnership allows transplant centers across the UK to work together to deliver clinical trials focused on stem cell transplantation. IMPACT provides funding for research nurses in eleven centers and works with a further eleven affiliated centers, which also participate in IMPACT trials. IMPACT trials are coordinated by the central hub, located at the University of Birmingham's Cancer Research UK Clinical Trials Unit (CRCTU). About the University of Birmingham The University of Birmingham is ranked amongst the world's top 100 institutions, and its work brings people from across the world to Birmingham, including researchers and teachers and more than 6,500 international students from nearly 150 countries. Forward-Looking Statements about Humanigen All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to continue as a going concern; our exploration of restructuring options, which may include a bankruptcy or other insolvency proceeding, and other strategic alternatives; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; the outcome of pending or future litigation or arbitration; and the various risks and uncertainties described in the "Risk Factors" sections of our latest annual and quarterly reports and other filings with the SEC. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law. Humanigen Investor Relations Contact Ed Jordan Chief Commercial Officer IR@humanigen.com 650-243-3181 Humanigen Media Relations Contact Charlotte Wray cwray@rxmedyn.com 646-247-3405 IMPACT Media Rebecca Collings Cancer Research UK Clinical Trials Unit Institute of Cancer and Genomic Sciences University of Birmingham RATinG@trials.bham.ac.uk University of Birmingham Press Office Emma McKinney, Media Relations Manager University of Birmingham e.j.mckinney@bham.ac.uk +44 (0)7789 921 165 References Zeiser, R., and Blazar, B. (2017). Acute graft-versus-host disease — biologic process, prevention, and therapy. New England Journal of Medicine, 377(22), 2167-2179. Harris, A.C., et al. (2016) International, Multicenter Standardization of Acute Graft-versus-Host Disease Clinical Data Collection: A Report from the Mount Sinai Acute GvHD International Consortium. Biol. Blood Marrow Transplant. 22:4-10. Malard, F. et al. (2020). Treatment and unmet needs in steroid-refractory acute graft-versus-host disease. Leukemia. 34:1229-1240 Gartlan, K. et al. (2019). Donor T-cell-derived GM-CSF drives alloantigen presentation by dendritic cells in the gastrointestinal tract. Blood Advances, 3(19), 2859-2865. Hartwell, M.J. et al. (2017). An early-biomarker algorithm predicts lethal graft-versus-host disease and survival. JCI Insights. 2(3):e89798. doi: 10.1172/jci.insight.89798. To view the source version of this press release, please visit

Cell Therapy

25 Jul 2023

·firstwordpharma.com

Humanigen sinks as it weighs bankruptcy option

Humanigen stated in a US securities filing that it may be forced to cease operations and file for bankruptcy now that a proposed business merger has fallen through. Company shares were down as much as 81% on Tuesday following the disclosure.According to the Securities and Exchange Commission filing, Humanigen was in negotiations with a privately-held biopharmaceutical firm about a proposed combination, but those talks have now "ended without execution of a definitive agreement."Humanigen said in the filing that it was also unsuccessful in its bid to complete a separate strategic or equity financing transaction so it could regain compliance with Nasdaq listing requirements by August 21. Moreover, it failed to raise sufficient debt or equity financing to continue as a going concern and is now exploring all restructuring options, including initiating bankruptcy or other insolvency proceedings in the third quarter.Meanwhile, board members John Hohneker, Cheryl Buxton and Kevin Xie all resigned from the company. Humanigen said the departures were not due to disagreements with the company on any matter relating to its operations, policies or practices, according to the filing.Last year, shares in the company took another hit after it reported that a US National Institutes of Health trial evaluating its lenzilumab antibody with Gilead Sciences' Veklury (remdesivir) in hospitalised patients with COVID-19 had failed to achieve its primary endpoint.

Executive Change

100 Deals associated with Lenzilumab

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KEGG	Wiki	ATC	Drug Bank
D11236	Lenzilumab	-	DB15148

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Graft Versus Host Disease	Phase 3	GB	Humanigen, Inc.	-
Chronic Myelomonocytic Leukemia	Phase 3	AU	Humanigen, Inc.	-
Non-Hodgkin Lymphoma	Phase 3	US	Humanigen, Inc.	-
Large B-cell lymphoma	Phase 1	US	Kite Pharma, Inc.	26 May 2020
Rheumatoid Arthritis	Phase 1	US	Humanigen, Inc.	01 Jan 2010
COVID-19	Preclinical	US	Humanigen, Inc.	05 May 2020
COVID-19	Preclinical	BR	Humanigen, Inc.	05 May 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


PREACH-M (ASH2023)	Phase 2/3	Chronic Myelomonocytic Leukemia	72	Lenzilumab + Azacitidine	(avbkpygnph) = mhqrdxkyxk vtfcrardek (eufmzqahyr )	Positive	09 Dec 2023
ACTRN12621000223831 (PREACH-M, EHA2023)	Phase 2/3	Chronic leukemia \| Neoplasms \| Chronic Myelomonocytic Leukemia \| Leukemia	72	LENZILUMAB + AZACITIDINE	(jzkjnsvoxj) = grrblibozp udtknmyhvi (scwbivbwcb )	-	08 Jun 2023
NCT04583969 (ACTIV-5/BET-B, CTgov)	Phase 2	COVID-19	527	Remdesivir+Lenzilumab (Remdesivir + Lenzilumab)	quczxnetwg(wsodelrdpv) = nekemkwnbc ucugzwizdx (supsrkahbv, lcstlezeaz - wlwyhobtup) View more	-	05 Jun 2023
				Placebo+Remdesivir (Remdesivir + Placebo)	quczxnetwg(wsodelrdpv) = azqkullpgn ucugzwizdx (supsrkahbv, sdbslicufm - rptcduwblz) View more
NCT04583969 (ACTIV-5/BET-B, Biospace) Manual	Phase 2	COVID-19	-	Lenzilumab+Remdesivir	(uetvswmlgx) = the trial did not achieve statistical significance on the primary endpoint fdtfmjhtrp (fyvnmvhorl ) View more	Negative	13 Jul 2022
				Placebo+Remdesivir
NCT04351152 (LIVE-AIR, Pubmed) Manual	Phase 3	COVID-19	520	Lenzilumab	(tfuvzeqbqr): HR = 2.54 (95% CI, 1.46 - 4.41), P-Value = 0.0009 View more	Positive	06 Jul 2022
				SOC
NCT04351152 (LIVE-AIR, Pubmed) Manual	Phase 3	COVID-19 \| Pneumonia	479	lenzilumab	(otvcbxnldt) = qpafpcttwc vhsywbnqax (itbdehgwww, 79 - 89) View more	Positive	01 Dec 2021
				Placebo	(otvcbxnldt) = uivzhtkkka vhsywbnqax (itbdehgwww, 72 - 83) View more
NCT04351152 (LIVE-AIR, Pubmed)	Phase 3	COVID-19	520	Lenzilumab	(dkgvpywcgx): HR = 1.54 (95% CI, 1.02 - 2.31), P-Value = 0.041	Positive	05 May 2021
				Placebo
NCT04351152 (Pubmed \| Mayo Clin Proc)	Phase 3	COVID-19	520	Lenzilumab 600 mg	(hqfzrepyiq) = nuetcemzuy mryftusrst (epgtozrclk )	-	01 Nov 2020
				Lenzilumab (Control cohort)	(hqfzrepyiq) = cohtyviddc mryftusrst (epgtozrclk )

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