A Phase II Study to Evaluate the Safety and Efficacy of L19TNF With Alkylating Chemotherapy for Patients With Recurrent IDH-mutant Astrocytoma or Oligodendroglioma

The purpose of this study is to explore the safety and efficacy of the antibody-cytokine fusion protein L19TNF alone or in combination with alkylating chemotherapy in patients with recurrent IDH mutant glioma.

Start Date30 Jan 2026

Sponsor / Collaborator

Philogen SpA

NCT07145112

/ Not yet recruitingPhase 1IIT

A Phase 1 Safety and Feasibility Study of Laser Interstitial Thermal Therapy (LITT) Followed by Lomustine (CCNU) for Recurrent Glioblastoma in Adults

This is a phase 1 study evaluating the safety and feasibility of laser interstitial thermal therapy (LITT) followed by lomustine (CCNU) for recurrent glioblastoma in adults. The primary aim is to evaluate the safety of the combination of LITT plus lomustine based on the assessment of treatment-related adverse events and the feasibility of completing LITT + lomustine in the proposed timeframe. The secondary aim is to assess overall survival for up to 2 years after the first dose of lomustine.

Start Date20 Oct 2025

Sponsor / Collaborator

University of California, Davis

[+1]

NCT07100730

/ Not yet recruitingPhase 3

A Global, Multicenter, Prospective, Controlled, Open-Label Pivotal Study of Iodofalan (131I) Solution for Injection (TLX101-Tx) Plus Lomustine Versus Lomustine Alone in Patients With Radiographically Confirmed Recurrent Glioblastoma at First Recurrence (IPAX BrIGHT [IPAX-3])

This global clinical trial which evaluates the efficacy and safety of TLX101-Tx, an investigational radiopharmaceutical therapy, in combination with lomustine versus lomustine alone in adult patients with first recurrence of glioblastoma. TLX101-Tx delivers targeted radiation to glioblastoma cells. The trial is conducted in two parts: Part 1 assesses safety and radiation dosing; Part 2 is a randomized comparison of the combination therapy against standard care.

Start Date01 Sep 2025

Sponsor / Collaborator

Telix Pharmaceuticals Ltd.

100 Clinical Results associated with Lomustine

100 Translational Medicine associated with Lomustine

100 Patents (Medical) associated with Lomustine

3,053

Literatures (Medical) associated with Lomustine

01 Sep 2025·HEMATOLOGICAL ONCOLOGY

Lomustine, Etoposide and Cyclophosphamide as Conditioning for Auto-HCT in Lymphomas.

Letter

Author: Santos, Kelli Borges Dos ; Ferreira, Júlia Diniz ; Samico, Rafaella Cabral ; Hallack Neto, Abrahão Elias ; Xavier, Ana Carolina ; Leal, Christianne Tolêdo de Souza

01 Sep 2025·INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS

Comprehensive Molecular Analysis in NRG Oncology/RTOG 9813: A Phase 3 Study of Radiation and Temozolomide Versus Radiation and BCNU/CCNU in Anaplastic Astrocytoma

Article

Author: Chang, Susan M ; Puduvalli, Vinay K ; McElroy, Joseph P ; Pugh, Stephanie L ; Shih, Helen A ; Aldape, Kenneth D ; Mehta, Minesh ; Hunter, Grant K ; Kavanagh, Brian D ; Robins, H Ian ; Bahary, Jean-Paul ; Werner-Wasik, Maria ; Ashby, Lynn Stuart ; Schultz, Christopher J ; Becker, Aline P ; Chakravarti, Arnab ; Fleming, Jessica L

PURPOSE:

There is a need to better understand the molecular features that characterize grade 3 astrocytomas and their significance in predicting clinical outcomes. The aim of this study was to determine the significance of the 2021 World Health Organization (WHO)-defined molecular subgroups, along with MGMT promoter methylation, and other alterations in NRG Oncology/RTOG 9813.

METHODS AND MATERIALS:

Mutation status was determined by immunohistochemistry and/or next-generation sequencing. Copy number alterations and MGMT methylation were determined by Affymetrix Oncoscan and/or Illumina 450K arrays. Progression-free survival and overall survival were estimated using the Kaplan-Meier method and tested using the log-rank test. Multivariable analyses used Cox proportional hazards models.

RESULTS:

Application of the 2021 WHO-defined criteria resulted in the reclassification of 26/79 (33%) patients to grade 4 astrocytoma, IDH-mutant or glioblastoma. When looking at newly assigned molecular grade, grade 3 patients experienced longer survival outcomes compared to grade 4 patients. As individual biomarkers, IDH1/2 mutations, MGMT promoter methylation, and ATRX mutations were each associated with longer survival, whereas TERT promoter mutations, EGFR amplification, and gain of chromosome 7/loss of 10 (Chr+7/-10) were associated with shorter survival. Similar survival outcomes were observed for MGMT methylated patients treated with radiation therapy (RT) and temozolomide (TMZ) or RT and BCNU/CCNU, and MGMT unmethylated patients treated with RT and TMZ. Additionally, IDH-mutant patients seemed to respond well to the addition of TMZ.

CONCLUSIONS:

This study demonstrated the importance of classifying patients according to the 2021 WHO-defined criteria. The majority of IDH-wildtype anaplastic astrocytomas (grade 3) were reclassified as glioblastoma (grade 4). These analyses also shed light on the efficacy of TMZ in certain molecular subgroups, where the addition of TMZ to RT appeared to benefit patients regardless of MGMT methylation status.

01 Aug 2025·JOURNAL OF NEURO-ONCOLOGY

Reirradiation for recurrent glioblastoma: the significance of the residual tumor volume

Article

Author: Gaipl, Udo S ; Fietkau, Rainer ; Frey, Benjamin ; Uder, Michael ; Putz, Florian ; Weissmann, Thomas ; Semrau, Sabine ; Schubert, Philipp ; Schnell, Oliver ; Schmidt, Manuel ; Stritzelberger, Jenny ; Saake, Marc ; Distel, Luitpold V ; Filimonova, Irina ; Eze, Chukwuka ; Heiland, Dieter Henrik ; Schmitter, Charlotte ; Schönecker, Stephan ; Lettmaier, Sebastian ; Bert, Christoph ; Mansoorian, Sina ; Höfler, Daniel ; Dörfler, Arnd ; Coras, Roland ; Delev, Daniel ; Blümcke, Ingmar ; Belka, Claus

Abstract:

Purpose:

Recurrent glioblastoma has a poor prognosis, and its optimal management remains unclear. Reirradiation (re-RT) is a promising treatment option, but long-term outcomes and optimal patient selection criteria are not well established.

Methods:

This study analyzed 71 patients with recurrent CNS WHO grade 4, IDHwt glioblastoma (GBM) who underwent re-RT at the University of Erlangen-Nuremberg between January 2009 and June 2019. Imaging follow-ups were conducted every 3 months. Progression-free survival (PFS) was defined using RANO criteria. Outcomes, feasibility, and toxicity of re-RT were evaluated. Contrast-enhancing tumor volume was measured using a deep learning auto-segmentation pipeline with expert validation and jointly evaluated with clinical and molecular-pathologic factors.

Results:

Most patients were prescribed conventionally fractionated re-RT (84.5%) with 45 Gy in 1.8 Gy fractions, combined with temozolomide (TMZ, 49.3%) or lomustine (CCNU, 12.7%). Re-RT was completed as planned in 94.4% of patients. After a median follow-up of 73.8 months, 88.7% of patients had died. The median overall survival was 9.6 months, and the median progression-free survival was 5.3 months. Multivariate analysis identified residual contrast-enhancing tumor volume at re-RT (HR 1.040 per cm3, p < 0.001) as the single dominant predictor of overall survival.

Conclusion:

Conventional fractionated re-RT is a feasible and effective treatment for recurrent high-grade glioma. The significant prognostic impact of residual tumor volume highlights the importance of combining maximum-safe resection with re-RT for improved outcomes.

News (Medical) associated with Lomustine

22 Apr 2025

·www.businesswire.com

Carthera Reaches Recruitment Milestone in SONOBIRD Pivotal Trial for Recurrent Glioblastoma

PARIS--(BUSINESS WIRE)--Carthera, developer of the revolutionary SonoCloud® medical device, today announces it has enrolled the first 100 patients in its SONOBIRD pivotal trial for the treatment of recurrent glioblastoma. A spin-off of Sorbonne University founded by noted neurosurgeon Prof. Alexandre Carpentier, Carthera reaches this milestone as it prepares to conduct the largest clinical trial ever using ultrasound for the temporary opening of the blood-brain-barrier (BBB) in patients with recurrent glioblastoma. Nearly all 40 participating sites across Europe and the U.S. are now active. Carthera anticipates that recruitment will continue swiftly to reach the 560 patients planned for the study. The trial (NCT05902169) is the world’s first randomized, multicentric, two-arm pivotal trial of BBB opening prior to chemotherapy injection in recurrent glioblastoma patients. Notably, the trial makes use of the SonoCloud, an innovative ultrasound-based medical device developed by Carthera to treat a wide range of brain disorders. Specifically, the trial compares the use of SonoCloud combined with carboplatin versus standard therapies in patients with a first recurrence of glioblastoma. “It has been a privilege to offer this trial to patients with recurrent glioblastoma. The underlying concept is highly promising, device implantation has proceeded smoothly and patients have shown strong interest in participating,” said Dr. Brian Gill, assistant professor of neurosurgery at Columbia University Irving Medical Center in New York. “We desperately need new treatments for patients with recurrent glioblastoma. SonoCloud has the potential to transform our ability to deliver a high dose of therapeutics to the brain,” said Dr. Marjolein Geurts, neuro‐oncologist at Erasmus Medical Center Cancer Institute in Rotterdam, the Netherlands. To date, more than 550 SonoCloud treatments have been performed worldwide, confirming Carthera’s position as a leader in the field of ultrasound-based BBB opening, as well as the growing interest in SonoCloud as a potentially viable new treatment option for patients with recurrent glioblastoma. “Our progress in recruiting patients reflects the engagement and strong support from our clinical sites, and from the neuro-oncology and surgery community, in advancing innovative therapies,” said Carole Desseaux, chief clinical officer at Carthera. “We are very grateful for the commitment and enthusiasm of the patients and clinicians who are taking part in this trial.” “Achieving this milestone is an important step in introducing our SonoCloud device to the large patient population urgently in need of solutions to improve treatment outcomes,” said Frederic Sottilini, CEO of Carthera. “With its breakthrough device and orphan drug designations, Carthera remains committed to transforming glioblastoma treatment and to acquiring market access for its groundbreaking technology.” Initiated in February 2024, the registrational study aims to enroll a total of 560 US and EU patients within two years, with a view to obtaining marketing authorization. The first interim analysis of the clinical data will be available soon. About the SONOBIRD trial The open-label, comparative, randomized, multicenter, two-arm clinical trial with a 1:1 ratio aims to evaluate overall survival in patients undergoing carboplatin chemotherapy and treated with the SonoCloud system to open the Blood-Brain Barrier (BBB). This is compared to the medical consensus recommended regimens (lomustine or temozolomide). The trial also evaluates the effectiveness of the SonoCloud and carboplatin treatment in delaying or slowing tumor growth. The SONOBIRD trial follows on from the SC9-GBM-01 trial, which demonstrated the feasibility and the safety profile of SonoCloud, as well as the potential of carboplatin tested as a monotherapy in combination with BBB opening. About SonoCloud SonoCloud® is an innovative medical device developed by Carthera. It emits ultrasound to temporarily increase the permeability of the blood vessels in the brain to improve the delivery of therapeutic molecules. Invented by Prof. Alexandre Carpentier and developed in collaboration with the Laboratory of Therapeutic Applications of Ultrasound (Laboratoire Thérapie et Applications Ultrasonores, LabTAU, INSERM) in Lyon, France, SonoCloud is an implant inserted into the skull and activated prior to injection of a therapeutic agent. Several minutes of low-intensity ultrasound opens the blood-brain barrier for six hours and increases the concentration of therapeutic molecules in the brain. This ultrasound-induced opening of the blood-brain barrier is a world-first. It offers a new treatment option for a wide range of indications, including brain tumors and Alzheimer’s disease. SonoCloud is an investigational product, the device has not yet received EMA or FDA approval. About Carthera Carthera is a clinical-stage medtech company focused on developing innovative ultrasound-based medical devices to treat a wide range of brain disorders. The company is a spin-off from AP-HP Paris and Sorbonne University. Carthera leverages the inventions of Prof. Alexandre Carpentier, head neurosurgeon at AP-HP Sorbonne university, who has achieved worldwide recognition for his innovative developments in treating brain disorders. Carthera is developing SonoCloud®, an intracranial implant that temporarily opens the blood-brain barrier. The device is currently in clinical trials in Europe and the United States. It received FDA Breakthrough Device Designation in 2022, and FDA/EMA Orphan Drug Designation in 2023 for carboplatin when used with SonoCloud. Founded in 2010 by Prof. Alexandre Carpentier, run by CEO Frederic Sottilini and chaired by Oern Stuge, MD, Carthera has offices in France (Lyon and Paris) and a subsidiary in Boston, Massachusetts. Since its inception, the technical and clinical development of SonoCloud has received support from the National Research Agency (ANR), the French public investment bank (Bpifrance), the National Institutes of Health (NIH) and the European Innovation Council (EIC). Additional information is available at www.carthera.eu.

Clinical StudyOrphan Drug

11 Jul 2024

·www.biospace.com

Kazia Offers Secondary OS Data to Build FDA Case for Glioblastoma Drug

Pictured: 3D illustration of a tumor on a brain/iStock, wildpixel Kazia Therapeutics on Wednesday unveiled additional data from the Phase II/III GBM-AGILE study, picking out secondary efficacy signals as it eyes an FDA accelerated approval pathway for its investigational glioblastoma treatment paxalisib. GBM-AGILE is a large global study designed to test several investigational glioblastoma treatments versus current standard of care. In the case of paxalisib, the study used chemotherapy with temozolomide for newly diagnosed patients and with lomustine for those with recurrent disease. The primary outcome of interest was overall survival (OS). Paxalisib showed no signs of efficacy in the recurrent disease setting. Median OS in treated patients was 8.05 months, which was nearly two months shorter than the 9.69-month median OS in comparators treated with lomustine. The Australian biotech is currently conducting deeper analysis of these data “to elucidate potential signs for further consideration.” Kazia is focused on the subset of patients who were newly diagnosed with glioblastoma. In this population, paxalisib led to a median OS of 14.77 months, slightly longer than that in temozolomide counterparts, who survived for a median of 13.84 months. The biotech further zoomed in on a smaller slice of control patients who were enrolled into GBM-AGILE concurrently with paxalisib’s inclusion into the study. In this concurrent population, median OS for paxalisib grew to 15.54 months while that for comparators dipped to 11.89 months. Kazia CEO John Friend pointed to this survival difference, saying that the biotech is “excited to have shown a 3.8-month improvement in overall survival, an approximate 33% improvement, for newly diagnosed unmethylated patients with GBM compared to the concurrent standard-of-care arm.” “Having comparable [OS] data across two independent studies in a compelling outcome in this difficult to treat population,” Friend noted, adding that the biotech will bring these findings to the FDA to discuss “possible approaches” to an accelerated approval for paxalisib. The market reacted favorably to Kazia’s readout, with its stocks surging 142% on Wednesday, according to SeekingAlpha. Initially invented by Genentech, paxalisib works by inhibiting the action of PI3K, a key player in cell growth and division which are highly dysregulated in several cancers. Unlike most other PI3K blockers, paxalisib can cross the blood-brain barrier making it a promising candidate for malignancies of the central nervous system. In August 2022, Kazia reported that paxalisib failed to reach the pre-defined criteria for moving to the second phase of GBM-AGILE. However, at the time, the biotech was still blinded to the study’s results and could not fully understand the failure. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Accelerated ApprovalClinical ResultDrug Approval

11 Jul 2024

·www.biospace.com

Kazia Offers Secondary OS Data to Build FDA Case for Glioblastoma Drug

3D illustration of a tumor on a brain iStock, wildpixel Kazia Therapeutics is eyeing an FDA accelerated approval pathway for its investigational glioblastoma drug paxalisib, with Wednesday’s release of secondary overall survival data from a Phase II/III trial. Kazia Therapeutics on Wednesday unveiled additional data from the Phase II/III GBM-AGILE study, picking out secondary efficacy signals as it eyes an FDA accelerated approval pathway for its investigational glioblastoma treatment paxalisib. GBM-AGILE is a large global study designed to test several investigational glioblastoma treatments versus current standard of care. In the case of paxalisib, the study used chemotherapy with temozolomide for newly diagnosed patients and with lomustine for those with recurrent disease. The primary outcome of interest was overall survival (OS). Paxalisib showed no signs of efficacy in the recurrent disease setting. Median OS in treated patients was 8.05 months, which was nearly two months shorter than the 9.69-month median OS in comparators treated with lomustine. The Australian biotech is currently conducting deeper analysis of these data “to elucidate potential signs for further consideration.” Kazia is focused on the subset of patients who were newly diagnosed with glioblastoma. In this population, paxalisib led to a median OS of 14.77 months, slightly longer than that in temozolomide counterparts, who survived for a median of 13.84 months. The biotech further zoomed in on a smaller slice of control patients who were enrolled into GBM-AGILE concurrently with paxalisib’s inclusion into the study. In this concurrent population, median OS for paxalisib grew to 15.54 months while that for comparators dipped to 11.89 months. Kazia CEO John Friend pointed to this survival difference, saying that the biotech is “excited to have shown a 3.8-month improvement in overall survival, an approximate 33% improvement, for newly diagnosed unmethylated patients with GBM compared to the concurrent standard-of-care arm.” “Having comparable [OS] data across two independent studies in a compelling outcome in this difficult to treat population,” Friend noted, adding that the biotech will bring these findings to the FDA to discuss “possible approaches” to an accelerated approval for paxalisib. The market reacted favorably to Kazia’s readout, with its stocks surging 142% on Wednesday, according to SeekingAlpha . Initially invented by Genentech, paxalisib works by inhibiting the action of PI3K, a key player in cell growth and division which are highly dysregulated in several cancers. Unlike most other PI3K blockers, paxalisib can cross the blood-brain barrier making it a promising candidate for malignancies of the central nervous system. In August 2022, Kazia reported that paxalisib failed to reach the pre-defined criteria for moving to the second phase of GBM-AGILE. However, at the time, the biotech was still blinded to the study’s results and could not fully understand the failure.

Clinical ResultAccelerated ApprovalDrug Approval

100 Deals associated with Lomustine

External Link

KEGG	Wiki	ATC	Drug Bank
D00363	Lomustine	L01AD02	DB01206

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Bronchogenic Carcinoma	China	Nanjing Pharmaceutical Factory	01 Jan 1982
Glioma	China	Nanjing Pharmaceutical Factory	01 Jan 1982
Lymphoma	China	Nanjing Pharmaceutical Factory	01 Jan 1982
Rectal Cancer	China	Nanjing Pharmaceutical Factory	01 Jan 1982
Stomach Cancer	China	Nanjing Pharmaceutical Factory	01 Jan 1982
Brain Cancer	United States	Corden Pharma Latina SpA	04 Aug 1976
Brain Cancer	United States	Azurity Pharmaceuticals, Inc.	04 Aug 1976
Hodgkin's Lymphoma	United States	Azurity Pharmaceuticals, Inc.	04 Aug 1976
Hodgkin's Lymphoma	United States	Corden Pharma Latina SpA	04 Aug 1976

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


CeTeG/NOA-09 (EANO2024)	Phase 3	Glioblastoma	31	Lomustine-Temozolomide Chemotherapy + Radiotherapy	dgrejwwcho(ffxgfaxpfz) = fxciwbseyy weeoolbdoz (bhkmevmtla )	Positive	17 Oct 2024
CeTeG/NOA-09 (EANO2024)	Not Applicable	Glioblastoma MGMT-methylated \| IDH-wildtype	17	CCNU/TMZ	iqzrpegyhp(kgnldomxnc) = wfrbgzhinp nmtlswcyec (gjixywdhyc, 17.6 - not reached) View more	Positive	17 Oct 2024
CTRI/2020/07/026696 (VAMANA, ASCO2024) Manual	Phase 2	Glioblastoma	46	bevacizumab+CCNU	kkpmcaymjn(aaggwuscgg) = lxwwnxalza hmnvmazwpt (atstzzjxrd, 5.474 - 6.793) View more	Positive	02 Jun 2024
EORTC 26101 (SNO2022)	Phase 2/3	Recurrent Glioblastoma	-	Lomustine alone	dtdnfbrjbt(wieerrqpzw) = Thrombocytopenia represents the main cause of stopping chemotherapy for toxicity during the treatment of glioblastoma zzbpitrlck (dhyhcivxpm ) View more	Negative	14 Nov 2022
				Lomustine plus bevacizumab
PROTECT (SNO2022)	Not Applicable	Low grade glioma Adjuvant 1p/19q co-deletion	20	Procarbazine, Lomustine, Vincristine (PCV)	swtkovlbnf(cbxjcoennj) = zmwtguuart xummbuugrq (uzeaohthbo ) View more	Negative	14 Nov 2022
				Temozolomide (TMZ)	swtkovlbnf(cbxjcoennj) = leigcrrnkz xummbuugrq (uzeaohthbo ) View more
NCT01775475 (CTgov)	Phase 2	AIDS-Related Lymphoma \| AIDS-Related Diffuse Large Cell Lymphoma \| Immunoblastic Large-Cell Lymphoma ... View more	7	laboratory biomarker analysis+cyclophosphamide+prednisone+doxorubicin hydrochloride+vincristine sulfate (Arm I (CHOP))	prmurhholt = tshxrqymnn vhlduzabxk (luaxbyhvzz, lmagtdimmg - secasxknfe) View more	-	10 Oct 2022
				laboratory biomarker analysis+etoposide+cyclophosphamide+lomustine+procarbazine hydrochloride (Arm II (Oral Chemotherapy))	prmurhholt = hbiuitzcxf vhlduzabxk (luaxbyhvzz, zuzvqncdhb - pxnanyeyrk) View more
CeTeG/NOA-09 (EANO2022)	Phase 3	First line	70	Lomustine plus Temozolomide	hvdlesdmhr(qponxbnocq) = bpufymohki qnfnubyozz (mmvbvdiggq ) View more	Positive	05 Sep 2022
				lomustine (TTFields treatment for 8 weeks or longer)	dozccgsgcd(vgcpnjcjus) = menwjyijvc tynbnrysjv (fxtmfyilmp )
NCT03022578 (CTgov)	Phase 2	Recurrent Glioblastoma	7	Laser Interstitial Thermal Therapy+Lomustine	iqbsujdgiq = yhqfkugojm vwahrzbuyx (oujrvldhki, wzqvhbxngf - stipocvpmh) View more	-	10 Aug 2022
NCT00002840 \| NCT00002569 (EORTC 26951 and RTOG 9402, Pubmed)	Phase 3	Oligodendroglioma Adjuvant	299	Radiotherapy+PCV	bkvuysblmv(ktlexhleup) = auiioetdkl qqtifresyu (bdusivvkoc ) View more	Positive	22 Jun 2022
				Radiotherapy	bkvuysblmv(ktlexhleup) = nakjjsluab qqtifresyu (bdusivvkoc ) View more
CeTeG/NOA-09 (SNO2021)	Not Applicable	Glioblastoma MGMT promotor-methylated \| RTK I/MES subgroup	98	Lomustine (RTK I/MES subgroup)	xmfhborqoa(ivdcyudrmk) = lrndbrzzis oktbrwxaqb (ufifhnosll )	Positive	12 Nov 2021
				Lomustine (RTK II subgroup)	xmfhborqoa(ivdcyudrmk) = kywahrvnsp oktbrwxaqb (ufifhnosll )

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