A Phase 2 Open-label Randomized Study of Farletuzumab Ecteribulin (MORAb-202), a Folate Receptor Alpha-targeting Antibody-drug Conjugate, Versus Investigator's Choice Chemotherapy in Women With Platinum-resistant High-grade Serous (HGS) Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

The purpose of the study is to assess the safety, tolerability, and efficacy of farletuzumab ecteribulin (MORAb-202) and compare it to Investigator's choice (IC) chemotherapy in female participants with platinum-resistant HGS ovarian, primary peritoneal, or fallopian tube cancer.

Start Date01 Feb 2023

Sponsor / Collaborator

Bristol Myers Squibb Co.

[+1]

NCT05577715

/ TerminatedPhase 2

A Phase 2, Open-label, Randomized Study of MORAb-202 (Farletuzumab Ecteribulin), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) After Progression on Prior Therapies

The aim of this study is to characterize the safety and tolerability of MORAb-202, and to assess the objective response rate in participants with previously treated, metastatic NSCLC AC.

Start Date14 Nov 2022

Sponsor / Collaborator

Bristol Myers Squibb Co.

[+1]

NCT04300556

/ RecruitingPhase 1/2

A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Subjects With Selected Tumor Types

The primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer [OC], endometrial cancer [EC], non-small cell lung carcinoma [NSCLC], triple-negative breast cancer [TNBC]), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin (MORAb-202) in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin (MORAb-202) and (3) dose-optimization part. (divided in two parts: Part A [OC and EC participants] and Part B [OC only]): Part A: to evaluate other farletuzumab ecteribulin (MORAb-202) treatment regimens for safety, tolerability and preliminary efficacy in participants with OC and EC; to evaluate the addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days; and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to evaluate the safety and tolerability of different doses of farletuzumab ecteribulin (MORAb-202) as monotherapy and in combination with lenvatinib and to determine the recommended dose (RD) of farletuzumab ecteribulin (MORAb-202) as monotherapy and in combination with lenvatinib.

Start Date06 Aug 2020

Sponsor / Collaborator

Eisai, Inc.

100 Clinical Results associated with Farletuzumab Ecteribulin

100 Translational Medicine associated with Farletuzumab Ecteribulin

100 Patents (Medical) associated with Farletuzumab Ecteribulin

520

Literatures (Medical) associated with Farletuzumab Ecteribulin

01 Dec 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Comprehensive assessments of pharmacokinetics and immunogenicity of farletuzumab ecteribulin, a novel antibody-drug conjugate against tumors expressing folate receptor α, in monkeys

Article

Author: Mano, Yuji ; Fernando, Shawn

Farletuzumab ecteribulin (MORAb-202) is a novel antibody-drug conjugate (ADC) comprising farletuzumab and eribulin with a cathepsin-B cleavable linker, currently under development for tumors expressing folate receptor α. It is crucial to comprehend the pharmacokinetics (PK) of MORAb-202 in monkeys to enhance the accuracy of PK prediction in humans. To this end, a series of assays were devised for the total antibody (Tab) as the sum of conjugated and unconjugated antibodies, the conjugated antibody as the ADC, and the unconjugated eribulin (payload) by a ligand binding assay (LBA) and liquid chromatography with tandem mass spectrometry. The LBA by Gyrolab was employed for the quantification of Tab and ADC. Additionally, a semi-quantitative assay for anti-drug antibody (ADA) was developed using the LBA for the immunogenicity assessment. The quantifiable range for ADC and Tab in monkey serum was from 0.4 and 4 µg/mL, respectively, while eribulin was quantified from 0.2 ng/mL. The aforementioned methodologies were subsequently validated and employed in a PK study in monkeys. The accuracy and precision of the assay were within the criteria. Following intravenous administration, the PK profiles of Tab and ADC were similar, while minimal levels of eribulin. No ADA against MORAb-202 was detected in postdose samples.

03 Nov 2025·MOLECULAR CANCER THERAPEUTICS

Antitumor Effect of Farletuzumab Ecteribulin in Molecular Subtypes of Endometrial Cancer Patient-Derived Xenograft Models

Article

Author: Hasegawa, Kosei ; Shintani, Daisuke ; Ogasawara, Aiko ; Nishikawa, Tadaaki ; Yagishita, Shigehiro ; Ishii, Hironori ; Uenaka, Toshimitsu ; Yasuda, Masanori ; Sato, Sho ; Yoshida, Hiroshi ; Hamada, Akinobu ; Furuuchi, Keiji

Abstract:

Endometrial cancer represents a significant health burden globally, particularly in postmenopausal women. Current treatment options for advanced-stage endometrial cancer remain limited, emphasizing the need for novel therapeutic strategies. This study aimed to investigate farletuzumab ecteribulin (FZEC), an antibody–drug conjugate targeting folate receptor α (FRα), as a potential new therapeutic agent for endometrial cancer. We utilized a panel of 22 patient-derived xenograft (PDX) models, representing various histologic and molecular subtypes of endometrial cancer with different levels of FRα expression, to evaluate the antitumor effect of FZEC. FZEC was administered intravenously at doses of 5 and 12.5 mg/kg on day 0. Intratumoral accumulation of eribulin, the payload of FZEC, was visualized using phosphor-integrated dot imaging. FZEC demonstrated dose-dependent antitumor effects across the endometrial cancer–PDX panel. At 5 mg/kg, the FZEC efficacy was associated with FRα expression, with 100% of FRα 3+ models exhibiting tumor shrinkage compared with 33.3% of FRα-negative models. FZEC also demonstrated broad activity across both histologic and molecular subtypes. Intratumoral eribulin accumulation was highly correlated with antitumor effects, even in models with low FRα expression. Follow-up studies confirmed FRα-dependent antitumor effects while also indicating potential FRα-independent mechanisms of action. FZEC demonstrated a robust antitumor effect against the FRα-high endometrial cancer–PDX models with significant antitumor effects also observed, even in FRα-low or FRα-negative models. Notably, intratumoral eribulin accumulation exhibited a stronger correlation with efficacy than with FRα expression alone. These findings support further clinical development of FZEC for endometrial cancer treatment and highlight the complexity of the mechanisms of action of antibody–drug conjugates.

01 Jun 2025·JOURNAL OF CLINICAL PHARMACOLOGY

Pharmacokinetic and Exposure–Response Modeling Support Body Surface Area‐Based Dosing of Farletuzumab Ecteribulin in Japanese Patients with Solid Tumors

Article

Author: Hasegawa, Kosei ; Zhu, Li ; Shimizu, Toshio ; Yasuda, Sanae ; Zhao, Yue ; Hamuro, Lora ; Yunokawa, Mayu ; Miura, Takuma ; Yonemori, Kan ; Matsumoto, Koji ; Nishio, Shin ; Hirashima, Yasuyuki ; Kozuki, Toshiyuki ; Takehara, Kazuhiro ; Yoshida, Tatsuya ; Kato, Hidenori ; Nomoto, Maiko ; Hayato, Seiichi ; Nishio, Makoto

Abstract:

The first‐in‐human, Phase 1 Study 101 showed antitumor activity and a tolerable safety profile of farletuzumab ecteribulin in Japanese patients with platinum‐resistant ovarian and non‐small cell lung cancer. A pharmacometric assessment evaluated farletuzumab ecteribulin pharmacokinetics and exposure–response (E‐R) relationships for efficacy and safety to support dose optimization. Patients received 0.3‐1.2 mg/kg of farletuzumab ecteribulin intravenously every 3 weeks. A pharmacokinetics (PK) model was developed and used for E‐R analyses. Efficacy was assessed via tumor response and safety via known treatment‐emergent adverse events (TEAEs) of farletuzumab ecteribulin, particularly pneumonitis/interstitial lung disease (ILD). Dosing scenarios were simulated to identify dosing that maximizes the probability of an objective response while minimizing the risk of ILD. The farletuzumab ecteribulin PK dataset included 1261 observations from 82 patients. The final model included an estimated population mean value for farletuzumab ecteribulin clearance of 0.0162 L/h. Body surface area (BSA) was a significant PK covariate and was included in the model. Body weight (BW) was associated with higher farletuzumab ecteribulin exposure. Using BW‐based dosing, farletuzumab ecteribulin AUC (area under the serum concentration–time curve) was higher in patients with tumor response or stable disease versus patients with progressive disease and higher in patients with ILD and other TEAEs. Dosing simulations showed that BSA‐based dosing (33 mg/m2) yielded similar tumor responses to BW‐based dosing (0.9 mg/kg) and decreased ILD rates. This study showed that BW‐based dosing resulted in higher risks of ILD events for patients with a high BW versus low BW, whereas BSA‐based dosing is predicted to reduce this risk while maintaining clinical efficacy.

News (Medical) associated with Farletuzumab Ecteribulin

26 Dec 2024

·www.echemi.com

Leadership Changes at Bristol-Myers Squibb: Who's the Next to Be Let Go?

On April 26, 2023, Bristol-Myers Squibb (BMS) announced a significant development that placed the company in the spotlight. The announcement revealed a major leadership change: after eight years as CEO, Dr. Giovanni Caforio would step down, passing leadership to Chief Commercialization Officer Chris Boerner. This leadership transition not only marked the end of a chapter in Caforio’s career but also posed unprecedented challenges for Boerner. Bristol-Myers Squibb is facing the severe challenge of a patent cliff, which is a critical test for the company. To ensure a smooth transition, Caforio’s resignation did not take immediate effect; instead, a carefully planned transition period lasted until November 1, 2023, when he formally handed over leadership, ushering in a new era for Bristol-Myers Squibb. This leadership change has profound implications for BMS and its closely associated biotechnology partners. Recently, the company announced the termination of cell therapy collaboration agreements with Century Therapeutics and Immatics, marking significant decisions under Boerner’s tenure—and they are unlikely to be the last. Under Caforio's leadership, BMS achieved remarkable milestones. The official statement highly praised Caforio’s contributions, including his leadership of the landmark merger with Celgene, the launch of 12 new drugs, and the doubling of company revenues. These achievements have fostered a high-performance corporate culture and an engaged workforce. However, these accomplishments present both inspiration and pressure for Boerner. BMS faces challenges in innovative drug development due to the expiration of patents on its three revenue pillars: Revlimid, Eliquis, and Opdivo. Together, these drugs generated $26 billion in sales in 2023, accounting for nearly 60% of the company's total revenue. The impending patent expirations create a sense of urgency for the company. In response, BMS has been actively engaged in the M&A market, acquiring companies such as Karuna, Mirati, and RayzeBio for a combined total of approximately $22.9 billion. The company is also investing significantly in introducing innovative drugs, exemplified by the $8.3 billion licensing deal with Brii Biosciences for its dual-target ADC drug BL-B01D1. For Boerner, these extensive acquisitions and introductions pose a formidable challenge, requiring time for integration and digestion. At the financial report meeting on February 2, 2024, Boerner made his debut, presenting his comprehensive insights on the company’s future. Despite challenges like the patent cliff and the Inflation Reduction Act (IRA), Boerner emphasized that core products such as Revlimid, Eliquis, and Opdivo will continue to generate cash flow, supporting the company’s innovative R&D pipeline. Boerner identified 2026 as the company's most challenging period, describing it as the “most critical risk exposure” due to the IRA’s impact taking effect in that year. Boerner’s strategic focus in the current phase is to "shorten the transition period as much as possible" by accelerating R&D while maintaining strict cost control. His core strategy involves prioritizing investments in high-potential projects and suspending lower-priority ones. For example, the acquisition of Karuna is not just about acquiring assets but also involves integrating its operating expenses. BMS needs to centralize management, improve efficiency, and free up resources for new assets. From the outset of his tenure, Boerner has emphasized the importance of repositioning underperforming products such as Abecma and Zeposia, ensuring they receive adequate resources to succeed. In July 2024, Eisai announced that its FRα ADC drug MORAb-202, which was part of a $3.1 billion collaboration, was returned by BMS. Despite high investment and strong performance in key areas, treatment-related adverse events such as interstitial lung disease/pneumonia limited its competitiveness. In August 2024, BMS terminated its partnership with Agenus for TIGIT/CD96 dual antibodies, leading to a $200 million loss. Similarly, collaborations such as the $3 billion investment with Immatics have also been terminated. These actions reflect Boerner's strategy of shortening transition periods and focusing on the future. So, who will be the next to face "return" at BMS?

Executive ChangeAcquisition

18 Nov 2024

·www.pharmaceutical-technology.com

AbbVie’s Elahere wins European approval for certain ovarian cancers

GlobalData market analysts predict that Elahere could generate up to $1.98bn in revenue for AbbVie by 2030. Credit: Skorzewiak via Shutterstock. The European Commission (EC) has granted marketing authorisation to AbbVie ’s Elahere (mirvetuximab soravtansine) for the treatment of folate receptor-alpha (FRα) platinum-resistant ovarian cancer, a decade since the approval of the latest treatment. Antibody-drug conjugate (ADC) Elahere has received European approval for the treatment of adult patients with FRα positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube or primary peritoneal cancers. The therapy is authorised for patients who have undergone one to three prior systemic treatment regimens. Approximately 35%-40% of ovarian cancer patients express FRα, a biomarker specifically targeted by Elahere. By delivering the cytotoxic agent DM4 directly to cancer cells while sparing healthy tissue, the treatment aims to minimise off-target effects and reduce toxicity compared to traditional chemotherapy. Elahere’s approval is supported by data from the Phase III MIRASOL trial (NCT04209855), which enrolled 453 patients with FRα-positive platinum-resistant ovarian cancer. The treatment demonstrated a significant and clinically meaningful 35% reduction in the risk of disease progression or death, compared to standard chemotherapy. Patients treated with Elahere had a median progression-free survival (PFS) of 5.6 months, slightly longer than the four months observed in patients who received standard chemotherapy. Moreover, patients in the Elahere arm showed a median overall survival (OS) of 16.5 months while those in the investigator’s choice chemotherapy arm had a median OS of 12.8 months. The approval of Elahere addresses an unmet need for patients with platinum-resistant ovarian cancer. “It’s been ten years since a new treatment for platinum-resistant ovarian cancer was approved in the EU, and now oncologists have an effective, new, targeted treatment option for these patients,” said Toon Van Gorp, professor of gynaecological oncology at the University of Leuven. AbbVie inherited Elahere as part of a $10.1bn acquisition of ImmunoGen . The drug received accelerated approval by the US Food and Drug Administration (FDA) in November 2022 and was granted full FDA approval in the US in March 2024. GlobalData market analysts predict that Elahere could generate up to $1.98bn in revenue for AbbVie by 2030. As the first FRα-targeted ADC approved in the EU, Elahere represents a competitive advantage for AbbVie in the ovarian cancer treatment landscape. GlobalData is the parent company of Pharmaceutical Technology. Elahere faces competition from Bristol Myers Squibb and Eisai ’s ADC farletuzumab ecteribulin, which is currently being investigated in Phase II trials. However, Elahere holds the first-to-market advantage. The drug is currently being investigated in three other ovarian cancer trials, in combination with Roche’s Avastin (bevacizumab) in the Phase III GLORIOSA study (NCT05445778), as a monotherapy in the Phase II PICCOLO study (NCT05041257), and with carboplatin in another Phase II trial (NCT05456685).

Drug ApprovalPhase 3Phase 2Clinical ResultADC

03 Jul 2024

·www.echemi.com

Strategic Analysis of Bristol-Myers Squibb's Adjustment of MORAb-202 in the Global Landscape

From a strategic perspective, Bristol-Myers Squibb has been continuously adjusting the priority of its product portfolio in global strategic collaborations, leading to the decision to discontinue MORAb-202. This does not necessarily mean the clinical failure of MORAb-202, but rather that it is of lower priority in the current product mix. Based on available information, MORAb-202 still shows a certain degree of potential. As for Elahere, one of its main challenges is the limited patient population, as it is only effective for patients with high FRα expression, which accounts for only 35-40% of the ovarian cancer population. Additionally, the safety issues of Elahere, particularly the eye toxicity, which has led to the termination of treatment for one patient due to vision impairment, cannot be ignored. As a result, the FDA has issued a black box warning for Elahere. In contrast, the data presented at the 2022 ASCO meeting showed that MORAb-202 is also effective for patients with FRα expression below 50% and did not exhibit eye toxicity. Therefore, despite the discontinuation, Daiichi Sankyo remains optimistic about MORAb-202 and plans to prioritize its further development. However, MORAb-202 also faces challenges. According to the data presented at ASCO, interstitial lung disease/pneumonia is the most common treatment-related adverse event, which is reflected across different dose groups. Although there was only one case of grade 3/4 severity, given the small sample size, the dose optimization and the benefit-risk balance of MORAb-202 still require careful consideration. In the context of the urgent demand for growth engines, Bristol-Myers Squibb's decision to discontinue MORAb-202, while not directly reflecting its clinical failure, does indicate that the company believes the drug has limited competitiveness. The potential of the FRα-ADC market is vast, but the discontinuation of MORAb-202 further highlights the complexity and uncertainty in this field. In the FRα-ADC field, the previously perceived "three musketeers" - Elahere, MORAb-202, and STRO-002 - all face their own challenges. The clinical data of STRO-002 did not show the expected advantages, and it also has safety issues such as neutropenia. With the approval of Elahere, the commercial value of STRO-002 has decreased significantly. The discontinuation of MORAb-202 further warns the market that investments and R&D in the FRα-ADC field require a clear-headed approach, objective assessment of early clinical data and significant business development transactions, and adequate preparation to address potential risks and challenges.

ADC

100 Deals associated with Farletuzumab Ecteribulin

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Small Cell Lung Cancer	Phase 2	United States	Eisai Co., Ltd.	28 Feb 2023
Non-Small Cell Lung Cancer	Phase 2	Japan	Eisai Co., Ltd.	28 Feb 2023
Non-Small Cell Lung Cancer	Phase 2	France	Eisai Co., Ltd.	28 Feb 2023
Non-Small Cell Lung Cancer	Phase 2	Spain	Eisai Co., Ltd.	28 Feb 2023
Peritoneal Neoplasms	Phase 2	United States	Bristol-Myers Squibb International Corp.	14 Feb 2023
Peritoneal Neoplasms	Phase 2	Japan	Bristol-Myers Squibb International Corp.	14 Feb 2023
Peritoneal Neoplasms	Phase 2	Australia	Bristol-Myers Squibb International Corp.	14 Feb 2023
Peritoneal Neoplasms	Phase 2	Belgium	Bristol-Myers Squibb International Corp.	14 Feb 2023
Peritoneal Neoplasms	Phase 2	Chile	Bristol-Myers Squibb International Corp.	14 Feb 2023
Peritoneal Neoplasms	Phase 2	Israel	Bristol-Myers Squibb International Corp.	14 Feb 2023

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03386942 (Study 101, Pubmed \| Int J Gynaecol Obstet)	Phase 1	Platinum-Resistant Ovarian Carcinoma folate receptor‐alpha (FRα)	45	Farletuzumab ecteribulin 0.9 mg/kg	dmagldhavm(tvimyhtqwr) = Interstitial lung disease (ILD)/pneumonitis occurred in 37.5% (Gr ≥3: 0%) of the 0.9 mg/kg group and 66.7% (Gr ≥3: 4.8%) of the 1.2 mg/kg group zqhigihqte (orxegeapfq ) View more	Positive	23 Dec 2025
				Farletuzumab ecteribulin 1.2 mg/kg
NCT05577715 (CTgov)	Phase 2	metastatic non-small cell lung cancer	31	MORAb-202	eozrdsaerb = qczqfjvcik tomaywfkmj (jwhmjkxuzo, gybidkrudl - ruchoeuweg) View more	-	04 Sep 2025
NCT05613088 (CTgov)	Phase 2	Ovarian Cancer \| Platinum-Resistant Fallopian Tube Carcinoma \| Platinum-Resistant Ovarian Carcinoma	106	MORAb-202	ayurxtnhog = bkiuwcfmxd tktfglsipm (xrizfoelrs, glhrxnetgx - nxikllbwan) View more	-	03 Jul 2025
NCT03386942 (ESMO_GCC2023)	Phase 1	Ovarian Cancer	82	MORAb-202 0.9 mg/kg	asceqpbcgk(wneiegdegd) = Translocation of HMGB1 and enhanced HSP90 production as ICD biomarkers were observed in triplicate tumor samples treated with MORAb-202 and eribulin fynsdmyrle (lmuwenpwjs ) View more	-	23 Feb 2023
				MORAb-202 1.2 mg/kg
ESGO2022	Phase 1	Platinum-Resistant Ovarian Carcinoma FRÎ±-expression levels	-	MORAb-202 0.9 mg/kg	ingwvhjoba(gpoybumjiv) = upgpelozpk dvwduayrua (hldqcwnjba )	-	20 Oct 2022
				MORAb-202 1.2 mg/kg	ingwvhjoba(gpoybumjiv) = wsnkaricfi dvwduayrua (hldqcwnjba )
NCT03386942 (ASCO2022)	Phase 1	Platinum-Resistant Ovarian Carcinoma	45	MORAb-202 0.9 mg/kg	athmhbeacj(hjrobnbxbv) = crqipkybpi kpunyagbnn (jblguvqrpf )	-	02 Jun 2022
				MORAb-202 1.2 mg/kg	athmhbeacj(hjrobnbxbv) = qbexejqfoo kpunyagbnn (jblguvqrpf )
NCT03386942 (ASCO2022)	Phase 1	Solid tumor	82	MORAb-202 BSA-based dosing (33 mg/m2)	lkxzgodare(bwoeoppekp) = rates of all-grade interstitial lung disease (ILD), an adverse event of interest, were lower at the 0.9 mg/kg dose vs the 1.2 mg/kg dose fgloxdvwrv (qwraxdjcir ) View more	-	02 Jun 2022
				MORAb-202 BW-based dosing (0.9 mg/kg)
SABCS2022	Phase 1	Triple Negative Breast Cancer FRα-positive \| sFRα	-	MORAb-202	uddynlsxri(yhnqqytytz) = The major toxicity observed with MORAb-202 treatment was hematologic toxicity wsayymluoq (rpyrlehdug ) View more	-	15 Feb 2022
				Eribulin
NCT03386942 (Pubmed \| Clin Cancer Res) Manual	Phase 1	Solid tumor Folate Receptor-α-Positive	22	MORAb-202	dnzcvrsetw(bvuhxhbydk) = gnqeohivrl rnysissqyv (nndqhepnwa ) View more	Positive	15 Jul 2021
NCT03386942 (ASCO2019)	Phase 1	Solid tumor	16	MORAb-202	lqecxsxdoj(jussrvnirs) = The most common TEAEs were leukopenia and neutropenia (50% each) kxmgjhiean (jmweieqorz )	Positive	26 May 2019

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