A Randomized, Multi-Center, Blinded, Placebo-Controlled Study of Mapatumumab ([HGS1012], a Fully Human Monoclonal Antibody to TRAIL-R1) in Combination with Sorafenib as a First-Line Therapy in Subjects with Advanced Hepatocellular Carcinoma

Start Date01 Jul 2011

Sponsor / Collaborator

Human Genome Sciences, Inc.

NCT01258608

/ CompletedPhase 1/2

A Randomized, Multi-Center, Blinded, Placebo-Controlled Study Of Mapatumumab ([HGS1012], A Fully Monoclonal Antibody To TRAIL-R1) In Combination With Sorafenib As A First-Line Therapy In Subjects With Advanced Hepatocellular Carcinoma

Mapatumumab is a fully human, agonist monoclonal antibody that activates the cell death pathway in tumor cells by specifically binding to TRAIL-R1 with high affinity. Sorafenib, a multikinase inhibitor, is the standard of care for treatment of patients with advanced hepatocellular carcinoma (HCC). The mechanisms of sorafenib and mapatumumab action suggest that these agents could interact synergistically. This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of mapatumumab in combination with sorafenib in subjects with advanced hepatocellular carcinoma.

Start Date08 Feb 2011

Sponsor / Collaborator

Human Genome Sciences, Inc.

[+1]

NCT01088347

/ CompletedPhase 1/2

A Phase 1b/2 Study With the Agonistic TRAIL-R1 Antibody, Mapatumumab, in Combination With Cisplatin and Radiotherapy as a First Line Therapy in Patients With Advanced Cervical Cancer.

Chemoradiotherapy has become the standard of care for women with locally advanced cervical cancer. The available data support a 30 to 50% reduction in the risk of death from cervical cancer for women with locally advanced disease undergoing radiotherapy (RT) and concomitant cisplatin-based chemotherapy compared to RT alone. Despite the fact that this is currently the best treatment of locally advanced cervical cancer, 5-year overall survival is still only 52%.
The fully human, agonist monoclonal antibody mapatumumab binds to the Tumor necrosis factor-Related Apoptosis-Inducing Ligand Receptor 1 (TRAIL-R1, DR4) and induces cytotoxicity in multiple tumor cell lines in vitro and in vivo. In multiple phase I and phase II studies, mapatumumab appeared to be safe both as single agent and in combination with chemotherapy, including cisplatin.
In cervical cancer cell lines, mapatumumab induced apoptosis in 51% of the cells. Mapatumumab in combination with irradiation increased apoptosis to 83%.
In this phase 1b/2 study, the investigators will evaluate the safety, tolerability and efficacy of mapatumumab in combination with cisplatin and radiotherapy in patients with locally advanced cervical cancer.

Start Date01 Mar 2010

Sponsor / Collaborator

University Medical Center Groningen

[+1]

100 Clinical Results associated with Mapatumumab

100 Translational Medicine associated with Mapatumumab

100 Patents (Medical) associated with Mapatumumab

Literatures (Medical) associated with Mapatumumab

01 Feb 2025·JOURNAL OF DAIRY SCIENCE

Targeted reproductive management for lactating Holstein cows: Reproductive and economic outcomes of Double-Ovsynch compared with a targeted approach based on resumption of estrus

Article

Author: Bilby, Todd R ; De Vries, Albert ; Factor, Luana ; Chebel, Ricardo C ; Peixoto, Phillip M G ; Jones, Kristi ; Montevecchio, Ana B ; Mirzaei, Ahmadreza ; Bisinotto, Rafael S ; Galvão, Klibs N

Accessibility to automated monitoring devices (AMD) has led to exploration of alternative reproductive management to ovulation synchronization protocols (OvSP) for first postpartum AI according to the cow's early postpartum estrus characteristics (EPEC). We hypothesized that pregnancy and economic outcomes of cows subjected to a targeted reproductive management (TRM) are not inferior to those of cows subjected to an OvSP for the first AI. This was a noninferiority, randomized clinical trial. Cows (n = 2,635) from one dairy were fitted with AMD and classified according to EPEC at 45 ± 3 DIM as estrual (high intensity AMD-detected estrus [primiparous: heat index ≥90, multiparous: heat index ≥70; 0 = minimum, 100 = maximum]) and anestrus (no estrus or low intensity estrus). Cows in the control treatment were enrolled in the Double-Ovsynch (GnRH on d -27, PGF_2α on d -20, GnRH on d -17 and -10, PGF_2α on d -3 and -2, GnRH on d -1, and timed AI [TAI] on d 0 at 73 ± 3 DIM). Anestrus cows enrolled in the TRM treatment were assigned to the hCG-Ovsynch (TRM1; hCG on d -17, GnRH on d -10, PGF_2α on d -3 and -2, GnRH on d -1, and TAI on d 0 at 73 ± 3 DIM). Estrual cows received PGF_2α at 60 to 73 DIM, when they were 6 to 22 d after a previous estrus, and if not inseminated in estrus within 7 d, were enrolled in the hCG-Ovsynch at 70 to 77 DIM (TRM2). Estrual cows in the TRM treatment that were ≥23 d from a previous estrus at 63 ± 3 DIM were enrolled in the hCG-Ovsynch at 63 ± 3 DIM and received TAI at 80 ± 3 DIM (TRM3). Pregnancy was diagnosed 32 ± 3 and 67 ± 3 d after AI. Cows were re-inseminated at AMD-detected estrus or at fixed time within 10 d after nonpregnancy diagnosis. The lactation gross profit was calculated as follows: (milk income + sale value + subsequent lactation calf value) - (rearing cost + feed cost + replacement cost + fixed cost + depreciation + reproductive management cost). Cows in the control treatment were more likely to be diagnosed pregnant 67 d after AI (control = 53.9% [95% CI = 51.1%, 56.6%]; TRM = 50.1% [95% CI = 47.2%, 53.0%]), independent of EPEC. The interaction between treatment and EPEC tended to affect the hazard of pregnancy throughout the lactation (control = referent; anestrus-TRM: adjusted hazard ratio = 1.01, 95% CI = 0.91, 1.13; estrual-TRM: adjusted hazard ratio = 0.83, 95% CI = 0.74, 0.94). Treatment did not affect gross profit, independent of EPEC (control = US$2,196.9 ± 25.6; TRM = US$2,221.9 ± 26.5). Alternative strategies for first postpartum AI according to a cow's EPEC may be possible with AMD, without affecting gross profit. The use of a single hCG treatment to presynchronize the estrous cycle of anestrus cows may be an alternative to the presynchronization with the Ovsynch protocol because despite slightly decreasing P/AI, it did not affect gross profit.

11 Jul 2023·Medical oncology (Northwood, London, England)

TRAIL-mediated signaling in bladder cancer: realization of clinical efficacy of TRAIL-based therapeutics in medical oncology.

Review

Author: Kudabayev, Yerlan ; Venera, Rakhmetova ; Farooqi, Ammad Ahmad ; Turgambayeva, Assiya ; Kapanova, Gulnara ; Akhmetova, Gulshara ; Tanbayeva, Gulnur

Bladder cancer is a therapeutically challenging disease and wealth of knowledge has enabled researchers to develop a clear understanding of mechanisms which underlie carcinogenesis and metastasis. Excitingly, research over decades has unveiled wide-ranging mechanisms which serve as central engine in progression of bladder cancer. Loss of apoptosis, drug resistance, and pro-survival signaling are some of the highly studied cellular mechanisms. Therefore, restoration of apoptosis in resistant cancers is a valuable and attractive strategy. Discovery of TRAIL-mediated signaling cascade is an intriguing facet of molecular oncology. In this review, we have provided an overview of the translational and foundational advancements in dissecting the genomic and proteomic cartography of TRAIL signaling exclusively in the context of bladder cancer. We have also summarized how different natural products sensitized drug-resistant bladder cancer cells to TRAIL-mediated apoptosis. Interestingly, different death receptors that activate agonistic antibodies have been tested in various phases of clinical trials against different cancers. Certain clues of scientific evidence have provided encouraging results about efficacy of these agonistic antibodies (lexatumumab and mapatumumab) against bladder cancer cell lines. Therefore, multipronged approaches consisting of natural products, chemotherapeutics, and agonistic antibodies will realistically and mechanistically provide proof-of-concept for the translational potential of these combinatorial strategies in well-designed clinical trials.

01 Jan 2022·American journal of cancer research

miR-3132 upregulates surface TRAIL to induce apoptotic cell death in cancer cells.

Article

Author: Lev, Avital ; El-Deiry, Wafik S ; Ralff, Marie D ; Dicker, David T ; Zhou, Yan ; Lulla, Amriti R

TRAIL-based therapies are of significant clinical interest because of its unique ability to induce apoptosis in cancer cells while sparing normal and untransformed cells. This selective antitumor potential of the TRAIL pathway has been harnessed by development of therapeutics including recombinant (rh)TRAIL and TRAIL-receptor agonist antibodies such as mapatumumab and lexatumumab. While these TRAIL-based therapies have proven successful in preclinical studies and safe in early phase clinical trials, the limited serum half-life has been a hurdle for further clinical development. Here we characterize miR-3132, a novel and first-in class TRAIL-inducing miRNA with potent anti-proliferative and pro-apoptotic effects in cancer cell lines. Initial mechanistic studies indicate that miR-3132 engages the interferon signaling pathway to induce TRAIL and subsequent TRAIL-dependent apoptosis in cancer cell lines. Our data further suggests that the binding of miR-3132 to toll-like receptors could be the upstream pathway for the interferon response. The current study the first report to demonstrate miR-3132's in vitro efficacy and preliminary mechanism of action in cancer cell lines.

News (Medical) associated with Mapatumumab

01 Aug 2007

·www.biospace.com

Human Genome Sciences, Inc. Announces Second Quarter 2007 Financial Results and Key Developments

ROCKVILLE, Md., Aug. 1 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc., today announced financial results for the quarter ended June 30, 2007. (Logo: ) "In the second quarter, we reported the positive final results of our Phase 2b clinical trial of Albuferon(R) in patients with chronic hepatitis C, and we initiated the second of two pivotal Phase 3 trials of LymphoStat-B(R) in patients with lupus," said H. Thomas Watkins, President and Chief Executive Officer. "All four of the Phase 3 trials planned for Albuferon and LymphoStat-B are now underway. We expect to complete enrollment in both of the Albuferon Phase 3 trials in 2007. Clinical results continue to emerge suggesting that each of these products has blockbuster potential if Phase 3 trials are successful. Our cash position is strong, and we are making steady progress toward commercialization." HGS reported that net cash burn for the six months ended June 30, 2007 amounted to $54 million, net of a $47.5 million milestone payment received from Novartis in the first quarter of the year. The Company continues to expect that net cash burn will amount to $145-165 million for the full year 2007. "We substantially reduced our net loss for the second quarter and first half of 2007, compared with the same periods a year ago," said Tim Barabe, Senior Vice President and Chief Financial Officer. "We controlled our net cash burn in the first half through a combination of increased revenues, clinical development cost-sharing and spending controls, and we continue on track to end 2007 with net cash burn of $145-165 million." SECOND QUARTER 2007 FINANCIAL RESULTS HGS reported increased revenues for the quarter ended June 30, 2007 of $9.0 million, compared with revenues of $2.2 million for the same period in 2006. This included $5.7 million in revenue recognized from the Albuferon agreement with Novartis, and $1.6 million in revenue recognized from the LymphoStat-B agreement with GlaxoSmithKline (GSK). The Company reported a reduced net loss of $51.3 million ($0.38 per share) for the quarter ended June 30, 2007, compared with a net loss for the second quarter of 2006 of $61.3 million ($0.47 per share). As of June 30, 2007, cash and investments totaled $704.4 million, of which $634.3 million is unrestricted and available for operations. This compares with cash and investments totaling $763.1 million, of which $701.9 million was unrestricted and available for operations, as of December 31, 2006. HGS reported increased revenues of $18.3 million for the first six months of 2007, compared to revenues of $9.1 million for the same period of the previous year. Revenues for the six months of 2007 included $11.4 million in revenue recognized from the Albuferon agreement with Novartis and $3.2 million in revenue recognized from the LymphoStat-B agreement with GSK. The Company reported a reduced net loss of $102.3 million ($0.76 per share) for the six months ended June 30, 2007, compared with a net loss of $123.4 million ($0.94 per share) for the same period of the previous year. HIGHLIGHTS OF RECENT PROGRESS Albuferon: Positive Final Results of Phase 2b Trial In June 2007, HGS announced the final results of a Phase 2b trial of Albuferon (albinterferon alfa-2b) in combination with ribavirin in patients with chronic hepatitis C. Albuferon requires half as many injections as Pegasys (peginterferon alfa-2a), the current market leader, and results to date suggest that Albuferon may offer efficacy at least comparable to Pegasys, with the potential for less impairment of quality of life and daily activity during treatment. The Company expects that the Phase 2b study results will be presented in full at a scientific meeting later in 2007. HGS expects to complete the enrollment of patients in two pivotal Phase 3 clinical trials of Albuferon before the end of 2007. These trials, assuming they are successful, will provide the data to support filing of global marketing applications for Albuferon in 2009. Albuferon is being developed by HGS and Novartis under an exclusive worldwide development and commercialization agreement entered into in June 2006. LymphoStat-B: Positive Phase 2 Data; Second Phase 3 Trial Initiated In June 2007, at the annual congress of the European League Against Rheumatism (EULAR), clinical investigators presented Phase 2 results demonstrating that LymphoStat-B (belimumab) produced significant improvements in disease activity in patients with active systemic lupus erythematosus (SLE). At Week 52, significant reductions in SLE disease activity were observed based on multiple clinical measures, including the patient response rate chosen as the primary efficacy endpoint of the Phase 3 trials. Continued improvements were observed from Week 52 through Week 76 in the 24-week extension phase of the trial. The data also suggested that LymphoStat-B was well tolerated and improved quality of life in patients with active SLE. In the second quarter, HGS initiated dosing in the second of two pivotal Phase 3 trials of LymphoStat-B. Both trials are expected to enroll patients throughout 2007, with completion of enrollment anticipated in 2008. LymphoStat-B is being developed by HGS and GSK under a definitive development and commercialization agreement entered into in August 2006. TRAIL Receptor Antibodies In April 2007, the Journal of Clinical Oncology published the results of the first human study of HGS-ETR1 (mapatumumab) along with a positive editorial. HGS is currently enrolling patients in a randomized Phase 2 trial of HGS-ETR1 in combination with Velcade (bortezomib) in patients with advanced multiple myeloma. Clinical and preclinical evidence continues to emerge suggesting that HGS-ETR1 and HGS-ETR2 (lexatumumab) have significant potential for use in the treatment of a broad range of cancers. HGS is in the planning stages of additional studies of its TRAIL receptor antibodies in randomized combination trials, and will report on their progress in the months ahead. Facilities Consolidation In May 2007, HGS completed the purchase and sale of a 51,000 square-foot laboratory facility for a net gain of $1.7 million. In addition, as a result of these transactions in the second quarter, the Company recorded a reversal of $2.0 million in previously accrued non-cash exit charges. HGS vacated the facility and subleased it to Novavax, Inc. in 2006. CONFERENCE CALL HGS management will hold a conference call to discuss this announcement today at 11 AM Eastern. Investors may listen to the call by dialing (800) 811-0667 or (913) 981-4901, passcode 6543425, five to 10 minutes prior to the call. A replay of the call will be available within a few hours after the call ends. Investors may listen to the replay by dialing (888) 203-1112 or (719) 457-0820, confirmation code 6543425. Today's conference call also will be webcast and can be accessed at . Investors interested in listening to the live webcast should log on before the conference call begins to download any software required. Both the audio replay and the archive of the conference call webcast will remain available for several days. ABOUT HUMAN GENOME SCIENCES The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs. The HGS clinical development pipeline includes novel drugs to treat hepatitis C, lupus, anthrax disease, cancer and other immune-mediated diseases. The Company's primary focus is rapid progress toward the commercialization of its two key lead drugs, Albuferon for hepatitis C and LymphoStat-B for lupus. Phase 3 clinical trials of both drugs are now under way. In June 2006, the U.S. government exercised its option to purchase 20,000 doses of ABthrax(TM) for the treatment of anthrax disease. Other HGS drugs in clinical development include two TRAIL receptor antibodies for the treatment of hematologic and solid malignancies. For more information about HGS, please visit the Company's web site at . Health professionals or patients interested in clinical trials involving HGS products may inquire via the "Contact Us" section of the Company's Web site, , or by calling (301) 610-5790, extension 3550. HGS, Human Genome Sciences, ABthrax, Albuferon and LymphoStat-B are trademarks of Human Genome Sciences, Inc. SAFE HARBOR STATEMENT This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences' current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the Company's unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company's ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company's dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the Company will continue to face risks related to animal and human testing, to the manufacture of ABthrax and to FDA concurrence that ABthrax meets the requirements of the ABthrax contract. If the Company is unable to meet the product requirements associated with the ABthrax contract, the U.S. Government will not be required to reimburse the Company for the costs incurred or to purchase any ABthrax doses. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise. HUMAN GENOME SCIENCES, INC. CONSOLIDATED STATEMENTS OF OPERATIONS Three months Six months ended June 30, ended June 30, 2007 2006 2007 2006 (dollars in thousands, except share and per share amounts) Revenue $9,007 $2,225 $18,270 $9,065 Costs and expenses: Research and development (a) 49,385 50,046 96,564 108,453 General and administrative (b) 13,159 12,359 25,128 25,750 Facility-related and restructuring charges (credits) (3,673) 16,840 (3,673) 16,840 Total costs and expenses 58,871 79,245 118,019 151,043 Income (loss) from operations (49,864) (77,020) (99,749) (141,978) Net investment income (expense) (1,405) 1,003 (2,549) 3,822 Gain on sale of investment - 14,759 - 14,759 Income (loss) before taxes (51,269) (61,258) (102,298) (123,397) Provision for income taxes - - - - Net income (loss) $(51,269) $(61,258) $(102,298) $(123,397) Net income (loss) per share, basic and diluted $(0.38) $(0.47) $(0.76) $(0.94) Weighted average shares outstanding, basic & diluted 134,239,831 131,348,704 134,136,177 131,285,664 (a) Includes stock-based compensation expense associated with the adoption of FAS 123(R) on January 1, 2006 of $3,380 ($0.03 per share) and $4,570 ($0.04 per share) for the three months ended June 30, 2007 and 2006, respectively. Includes stock-based compensation expense of $6,350 ($0.05 per share) and $8,922 ($0.07 per share) for the six months ended June 30, 2007 and 2006, respectively. (b) Includes stock-based compensation expense associated with the adoption of FAS 123(R) on January 1, 2006 of $2,295 ($0.02 per share) and $2,704 ($0.02 per share) for the three months ended June 30, 2007 and 2006, respectively. Includes stock-based compensation expense of $4,345 ($0.03 per share) and $5,213 ($0.04 per share) for the six months ended June 30, 2007 and 2006, respectively. CONSOLIDATED BALANCE SHEET DATA: As of As of June 30, 2007 December 31, 2006 (dollars in thousands) Cash, cash equivalents and investments (c) $704,428 $763,084 Total assets (c) 1,047,492 1,149,668 Total debt and capital lease, less current portion 752,874 751,526 Total stockholders' equity 125,462 213,923 (c) Includes $70,082 and $61,165 in restricted investments at June 30, 2007 and December 31, 2006, respectively. Photo: NewsCom: AP Archive: PRN Photo Desk, photodesk@prnewswire.comHuman Genome Sciences, Inc. CONTACT: Jerry Parrot, Vice President, Corporate Communications,+1-301-315-2777, or Kate de Santis, Director, Investor Relations,+1-301-251-6003, both of Human Genome Sciences, Inc. Web site: Company News On-Call: /

CollaborateFinancial StatementAntibodyInnovative Drug

100 Deals associated with Mapatumumab

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KEGG	Wiki	ATC	Drug Bank
D04858	Mapatumumab	-	-

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Hepatocellular Carcinoma	Phase 2	United States	GSK Plc	08 Feb 2011
Advanced Hepatocellular Carcinoma	Phase 2	Germany	GSK Plc	08 Feb 2011
Advanced Hepatocellular Carcinoma	Phase 2	Poland	GSK Plc	08 Feb 2011
Advanced Hepatocellular Carcinoma	Phase 2	Puerto Rico	GSK Plc	08 Feb 2011
Advanced Hepatocellular Carcinoma	Phase 2	Romania	GSK Plc	08 Feb 2011
Advanced Hepatocellular Carcinoma	Phase 2	Russia	GSK Plc	08 Feb 2011
Advanced Hepatocellular Carcinoma	Phase 2	Ukraine	GSK Plc	08 Feb 2011
Advanced Cervical Carcinoma	Phase 2	Netherlands	Human Genome Sciences, Inc.	01 Mar 2010
Non-Small Cell Lung Cancer	Phase 2	Germany	Human Genome Sciences, Inc.	01 Jan 2007
Non-Small Cell Lung Cancer	Phase 2	Hungary	Human Genome Sciences, Inc.	01 Jan 2007

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01258608 (CTgov)	Phase 1/2	Advanced Hepatocellular Carcinoma	101	Placebo+Sorafenib (Sorafenib+Placebo)	rjiftintcu(aiwkbzrtlm) = didzuoxubh wuxvycgbho (glgqqbhnmr, kzmoqgwkfe - altifhrfop) View more	-	19 Dec 2018
NCT01258608 (CTgov)	Phase 1/2	Advanced Hepatocellular Carcinoma	101	Mapatumumab+Sorafenib (Sorafenib+Mapatumumab 30 mg/kg)	rjiftintcu(aiwkbzrtlm) = umuzpmkgaw wuxvycgbho (glgqqbhnmr, iaodybccoy - arcpktbqzc) View more	-	19 Dec 2018
NCT01258608 (Pubmed \| Ann Oncol) Manual	Phase 2	Advanced Hepatocellular Carcinoma	101	sorafenib+mapatumumab	ramgxiibri(qtggwrdpvt) = argtvktdtx ijdjpawwvz (ekbdtbkxvn )	Negative	01 Apr 2016
NCT01258608 (Pubmed \| Ann Oncol) Manual	Phase 2	Advanced Hepatocellular Carcinoma	101	sorafenib+Placebo	ramgxiibri(qtggwrdpvt) = hgbnjvpckq ijdjpawwvz (ekbdtbkxvn )	Negative	01 Apr 2016
ASCO2008	Phase 1	Advanced Malignant Solid Neoplasm	49	Mapatumumab	qcohqopyop(rdsdpkwtwh) = upmvxvirdi dzuhpgvcto (ppgwgnqfgf ) View more	-	20 May 2008
ASCO2005	Phase 1	Advanced Malignant Solid Neoplasm	24	HGS-ETR1	incfoqldzi(nhpiikrzto) = wgwdiqttdq lvsfumswxy (amnpmxwbyu )	-	01 Jun 2005

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