This is a single-center, prospective, randomized, controlled (crossover) clinical study designed to investigate the impact of lowering insulin levels on hepatic glucose production (HGP) vs de novo lipogenesis (DNL) in people with insulin resistance. The investigators will recruit participants with a history of overweight/obesity and evidence of insulin resistance (i.e., fasting hyperinsulinemia plus prediabetes and/or impaired fasting glucose and/or Homeostasis Model Assessment of Insulin Resistance [HOMA-IR] score >=2.73), and with evidence of metabolic dysfunction-associated steatotic liver disease (MASLD). Participants will undergo two pancreatic clamp procedures -- one in which serum insulin levels are maintained near hyperinsulinemic baseline (Maintenance Hyperinsulinemia or "MH" Protocol) and the other in which serum insulin levels are lowered by 50% (Reduction toward Euinsulinemia or "RE" Protocol). In both clamps the investigators will use stable-isotope tracers to monitor hepatic glucose and triglyceride metabolism. The primary outcome will be the impact of steady-state clamp insulinemia on HGP vs DNL.

Start Date01 Dec 2024

Sponsor / Collaborator

Columbia University

[+2]

NCT06592261 / RecruitingPhase 1IIT

Human Models of Selective Insulin Resistance: Graded Insulin Suppression Test (GIST) Pilot & Feasibility Study

The goal of this study is to learn about how the hormone insulin controls blood sugar in a variety of people. The main question it aims to answer is about how much insulin the body actually needs to maintain a normal blood sugar level. Participants will be asked to come in for a one-day study visit in which they will undergo a "graded insulin suppression test" ("GIST"). The GIST involves intravenous (into the vein) infusions of octreotide, a medication that turns off the body's own production of insulin, as well as replacement insulin at two different levels (low and high) and glucose (sugar). The study investigators will check blood sugar levels every few minutes during the procedure to determine the effect of the two different insulin levels. This study will evaluate the GIST in both healthy volunteers and those at higher risk for type 2 diabetes.

Start Date16 Sep 2024

Sponsor / Collaborator

Columbia University

[+1]

NCT06505395 / RecruitingPhase 2

A Phase Ⅱ Randomized, Parallel-group, Open-label, Active-controlled Trial to Assess the Efficacy, Safety and Pharmacokinetics of the Long-acting Octreotide Subcutaneous Injection (SYHX2008) Versus Octreotide Microspheres (Sandostatin LAR@) in Patients With GEP-NET

The purpose of this study is to compare the effectiveness, safety, pharmacokinetics (PK) of SYHX2008 vs Octreotide Microspheres (Sandostatin LAR@) in patients with advanced, well-differentiated GEP-NET.

Start Date30 Jul 2024

Sponsor / Collaborator

CSPC Zhongqi Pharmaceutical Technology (Tianjin) Co., Ltd.

100 Clinical Results associated with Octreotide Acetate

100 Translational Medicine associated with Octreotide Acetate

100 Patents (Medical) associated with Octreotide Acetate

1,307

Literatures (Medical) associated with Octreotide Acetate

01 Sep 2024·Cureus Journal of Medical Science

Effective Control of Pancreatitis-Related Gastric Varices Through Splenic Artery Embolization: A Case Report.

Article

Author: Cruz Rodriguez, Jerry ; Castellanos-Castillo, Isabel ; Jiménez García, José C ; Pérez Refojos, Carlos J

The development of isolated gastric varices (IGVs) is a rare manifestation in the setting of chronic pancreatitis (CP). However, due to the proximity of the pancreas to the splenic vein, splenic vein thrombosis (SVT) secondary to compression from CP can lead to the development of IGVs. We report a case of a 57-year-old patient with a history of CP status post Whipple procedure with upper GI bleeding from IGV formation. Initial endoscopic evaluation revealed scattered and prominent bleeding varies in the stomach with no evidence of esophageal variceal development. Subsequent CT angiography revealed SVT as the underlying cause of the variceal formation. The patient initially received medical management with IV sandostatin for bleeding control, and a splenectomy was planned as the definitive management. However, because the patient had undergone a Whipple procedure and developed fragile scattered varices, splenic artery embolization was chosen over splenectomy. Splenic artery embolization led to a successful reduction in gastric variceal size and no recurrence of bleeding. This case report presents a case of pancreatitis-induced splenic vein thrombosis (PISVT) and highlights splenic artery embolization as a viable management strategy in such cases.

12 Aug 2024·Cureus Journal of Medical Science

Primary Neuroendocrine Carcinoma of the Ileum With Markedly Elevated Carcinoembryonic Antigen (CEA) Levels: A Case Report

Article

Author: Nakamatsu, Dai ; Fujii, Yoshifumi ; Nishida, Tsutomu ; Hosokawa, Kana ; Yamamoto, Masashi ; Matsumoto, Kengo ; Sugimoto, Aya ; Fukui, Koji

Neuroendocrine carcinomas (NECs) are rare and highly malignant tumors with a generally poor prognosis. Carcinoembryonic antigen (CEA) is often associated with adenocarcinoma, but its significant elevation in NEC cases is unusual. A 69-year-old man was admitted to our hospital in January 2016 due to syncope induced by anemia. The patient had a hemoglobin level of 8.0 g/dL and an ileocecal mass causing small bowel obstruction on computed tomography. His CEA level was markedly elevated at 3625.4 ng/mL. A colonoscopy revealed a neoplastic lesion in the terminal ileum, leading to an emergency ileocecal resection. Pathology confirmed a NEC, positive for synaptophysin and CEA, with a Ki-67 index of 30%. The patient was diagnosed with stage IIIb NEC (pT3N2M0). A postoperative increase in CEA to 4124.6 ng/mL and metastases in the right lung and multiple lymph nodes were detected. Initial chemotherapy with irinotecan, cisplatin (IP), and octreotide acetate proved ineffective. Subsequent octreoscans showed disease progression. Switching to everolimus as second-line therapy temporarily decreased CEA levels and tumor size, but the disease progressed with cervical lymph node involvement. The patient underwent palliative radiotherapy but succumbed to disease progression in May 2018, with a final CEA level of 36,643 ng/mL. Necropsy of the cervical lymph nodes was consistent with the original surgical findings. This case highlights the aggressive nature and challenging management of NEC with significantly elevated CEA levels.

30 Jul 2024·Gland Surgery

Characteristics and treatment of a silent somatotroph tumor that had transformed to a functional type: a case report and literature review.

Article

Author: Wu, Yinzi ; Li, Zhenwei ; Wang, Renzhi ; Bao, Xinjie ; Sun, Jian

Background:

"Functionalization" of silent pituitary neuroendocrine tumors (PitNETs) is a pretty rare clinical phenomenon that reportedly occurs most often with silent corticotroph tumors (SCTs). We report the case of silent somatotroph tumor (SST) that had transformed to functional type. We also review similar cases of SST with functionalization.

Case Description:

A 43-year-old man without suggestive symptoms of a pituitary tumor was referred with a lesion in the sellar region detected incidentally. Serum insulin-like growth factor 1 (IGF-1) (348 ng/mL) was high, whereas growth hormone (GH) was within the normal range. A glucose GH inhibition test showed inhibition of GH to 0.4 ng/mL. Subtotal tumorectomy was performed via a transnasal-sphenoidal approach. Histopathological examination of the operative specimen showed weak expression of GH and diffuse staining of pituitary-specific transcription factor-1 (Pit-1). The final pathological diagnosis was SST. Five years after the first surgery without follow-up, the patient presented again because of headache, impaired vision, bone pain, and high blood glucose concentrations for 2 months. Physical examination showed early acromegalic features. Of interest, greatly increased concentrations of GH (7.2 ng/mL) and IGF-1 (533 ng/mL) were found. Magnetic resonance imaging showed the recurrence of tumor. A diagnosis of acromegaly was considered. The patient underwent a second transsphenoidal pituitary tumor resection, after which his serum GH and IGF-1 concentrations decreased. Unlike the original surgical specimen, immunohistochemical examination of the tissue resected during the second surgery showed strong GH positivity, with similarly strong Pit-1 positivity. The patient was followed up for 6 months without octreotide treatment. At the last follow-up, he was found to have high serum concentrations of GH and IGF-1, which demonstrated another progression of the remnant PitNET. After two courses of octreotide acetate microspheres (20 mg/month), the acromegaly was under control.

Conclusions:

In addition to SCTs, other silent PitNETs could also functionalize. Medical teams of PitNETs should recognize this rare phenomenon and conduct long-term follow-up. After functionalization, these tumors have a high recurrence rate, requiring multiple therapies and long-term follow-up. Further research is essential to determine the mechanism of regulation of secretion of GH by such tumors.

News (Medical) associated with Octreotide Acetate

22 Oct 2024

·endpts.com

FDA hits Camurus with CRL for acromegaly therapy over manufacturing issues

The FDA handed a CRL to the Swedish biotech Camurus for its hormone disorder therapy over “facility-related deficiencies” at a third-party manufacturer. The therapy, dubbed CAM2029, had a PDUFA date of Oct. 21 for acromegaly, but production issues were found at a third-party factory in September. There were no issues with the candidate’s efficacy or safety, Camurus said in a Tuesday release. CAM2029 does not have a new decision date, but Camurus said “timely resolution of the CRL” will depend on the unnamed third-party manufacturer’s responses. Labeling discussions for the asset were already in the final stages when the CRL was given, the company said. Acromegaly occurs when the body makes too much growth hormone, which leads to abnormally large hands and feet. Subcutaneously administered CAM2029 features a peptide inhibitor of growth hormones called octreotide. Camurus announced data from a pair of Phase 3 trials investigating CAM2029 in June and July 2023, showing acromegaly symptoms improved in patients. In May, Camurus said the EMA had received its regulatory application. Jefferies analysts said the delay could lead to Camurus launching its drug later than expected. Crinetics Pharmaceuticals has its own acromegaly candidate and announced the submission of its FDA application last month. CAM2029 is also being investigated for gastroenteropancreatic neuroendocrine tumors and polycystic liver disease.

Phase 3NDA

22 Oct 2024

·www.camurus.com

Camurus provides regulatory update on the US NDA for CAM2029 in acromegaly

Lund, Sweden — 22 October 2024 — Camurus (NASDAQ STO: CAMX) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the new drug application (NDA) for CAM2029 (octreotide) extended-release injection for the treatment of patients with acromegaly. The CRL is attributed to facility-related deficiencies identified during a Current Good Manufacturing Practices (cGMP) inspection of a third-party manufacturer completed in September 2024. FDA has communicated that its determination of responses from the facility as satisfactory is needed for a timely resolution of the CRL and approval of the NDA. The CRL did not state any other concerns, including related to clinical efficacy or safety of CAM2029. “The CRL is disappointing, however, we are confident in the data supporting our NDA and the potential of CAM2029 to address unmet medical needs of patients with acromegaly”, says Fredrik Tiberg, Camurus’ President & CEO. “Camurus is committed to working with the FDA and the third-party manufacturer to bring CAM2029 to patients living with acromegaly as soon as possible.” Labelling discussions with the FDA were held during the final stage of the NDA review and the prescribing information for CAM2029 is well advanced. In parallel with the US NDA process, a Market Authorization Application for CAM2029 for the treatment of acromegaly is under review in the EU. In addition, two development programs for CAM2029 for treatment of gastroenteropancreatic neuroendocrine tumors and polycystic liver disease are progressing. The CRL does not impact on the advancement of these programs. For more information Fredrik Tiberg, President & CEO Tel. +46 (0)46 286 46 92 fredrik.tiberg@camurus.com Fredrik Joabsson, Chief Business Development Officer Tel. +46 (0)70 776 17 37 ir@camurus.com About acromegaly Acromegaly is a rare, slowly progressive disease, typically caused by a tumor of the pituitary gland producing excess growth hormone and stimulating increased insulin growth factor-1 (IGF-1) levels. This results in abnormal growth of bone and tissue, enlarged hands, feet, facial features and inner organs, and symptoms such as fatigue, joint pain, headache, visual field defects, excessive sweating, and paresthesia.1 Inadequate biochemical and symptom control can have detrimental impacts on quality of life and mortality of patients with acromegaly.2,3 The prevalence of acromegaly is estimated to about 60 cases per million.4 About CAM2029 Octreotide SC depot, CAM2029, is an investigational, ready-to-use octreotide for subcutaneous administration under development for the treatment of acromegaly, as well as gastroentero-pancreatic neuroendocrine tumors (GEP-NET), and polycystic liver disease (PLD). CAM2029 is designed for enhanced octreotide exposure and convenient, once-monthly administration with a prefilled pen to facilitate easy self-administration by patients. The CAM2029 clinical program for acromegaly comprises of seven clinical trials, including four Phase 1 studies, one Phase 2 study, and two Phase 3 studies within the ACROINNOVA clinical program. CAM2029 has demonstrated an approximate five-fold higher bioavailability compared to the currently approved, long-acting, intramuscular (IM) octreotide.5 In the Phase 3 ACROINNOVA program, CAM2029 showed superior biochemical control compared to placebo as well as improvements in symptom control, treatment satisfaction, and quality of life compared to SoC at baseline with first-generation somatostatin receptor ligands (SRLs), octreotide and lanreotide. The safety profile of CAM2029 was consistent with SoC with no new findings.6,7 CAM2029 has received orphan drug designation for acromegaly (EU) and for polycystic liver disease (EU and US). About Camurus Camurus is a Swedish, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the company’s proprietary FluidCrystal® drug delivery technologies and its extensive R&D expertise. Camurus’ clinical pipeline includes products for the treatment of dependence, pain, cancer and endocrine diseases, which are developed in-house and in collaboration with international pharmaceutical companies. The company’s shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com. References Colao A., et al. Acromegaly. Nat Rev Dis Primers. 2019;5(1):20. Webb SM, et al. Quality of Life in Acromegaly. Neuroendocrinology. 2016;103(1):106-111. Fleseriu M, et al Acromegaly: pathogenesis, diagnosis, and management. Lancet Diabetes Endocrinol. 2022 Nov;10(11):804-826. Crisafulli S., et al. Global epidemiology of acromegaly: a systematic review and meta-analysis. Eur J Endocrinology. 2021; 185:251-63. Prescribing Information SANDOSTATIN® LAR, https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021008Orig1s047Corrected_lbl.pdf Ferone, D., et al. Octreotide subcutaneous depot for acromegaly: A randomized, double-blind, placebo-controlled phase 3 trial, ACROINNOVA 1. J Clin Endocrinol Metab. Published 8 October, 2024. https://doi-org.libproxy1.nus.edu.sg/10.1210/clinem/dgae707 Press release 15 July, 2024: https://www.camurus.com/media/press-releases/2024/camurus-announces-positive-phase-3-results-from-the-acroinnova-2-study-of-octreotide-sc-depot-cam2029-in-acromegaly-patients/ This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the managing director, at 1:00 am CET on 22 October 2024.

Clinical ResultPhase 3Orphan DrugNDAPhase 2

22 Oct 2024

·www.biospace.com

FDA Rejects Camurus’ Rare Hormonal Disorder Treatment Due to Manufacturing Problems

iStock, hapabapa The regulator cited deficiencies at a third-party manufacturing facility. Camurus is seeking approval for its extended-release subcutaneous formulation of octreotide, which would allow more convenient once-monthly dosing for patients with acromegaly. The FDA has rejected Camurus’ investigational subcutaneous formulation of octreotide, dubbed CAM2029, for the treatment of the rare hormonal disorder acromegaly, the Swedish drugmaker announced on Tuesday. In a Complete Response Letter (CRL), the regulator cited “facility-related deficiencies” discovered last month during an inspection of a third-party manufacturer as the reason for the rejection and did not point to other issues, particularly as regards CAM2029’s clinical efficacy or safety data. The FDA needs to receive “satisfactory” responses from Camurus’ third-party provider before it can resolve the CRL, according to the company. CEO Fredrik Tiberg in a statement called the CRL “disappointing” but noted that the company remains “confident in the data supporting our [New Drug Application] and the potential of CAM2029 to address unmet medical needs of patients with acromegaly.” CRLs from the FDA rejecting drug candidates due to manufacturing issues are on the rise . Out of a total of 238 CRLs issued between 2017 and 2023, 30% involved quality/manufacturing issues —particularly problems with manufacturing processes, facility inspections, or chemical, manufacturing and controls. Camurus will work with its external manufacturer and with the FDA “to bring CAM2029 to patients living with acromegaly as soon as possible,” Tiberg said. To this end, the company said that it has already held labelling discussions with the regulator and that CAM2029’s prescribing information is “well advanced.” Afflicting around sixty patients per one million people, acromegaly is a rare and slowly progressive disease characterized by the abnormal growth of bones and enlarged hands, feet and facial features. Acromegaly also affects internal organs and can typically include symptoms such as headaches, joint pain and fatigue. Acromegaly is often caused by a tumor in the pituitary gland, which leads to the excess production of growth hormone and insulin growth factor-1. When uncontrolled, acromegaly worsens patients’ quality of life or can heighten their risk of death. Octreotide, the active ingredient of CAM2029, is a peptide drug that is well-known as an acromegaly therapy. It works by mimicking the function of somatostatin, a naturally occurring hormone, and activating its corresponding receptor. This mechanism of action helps suppress growth hormone, addressing the underlying cause of acromegaly. Octreotide also lowers the levels and activity of insulin and glucagon. The pharma industry has long taken advantage of octreotide’s therapeutic effects for acromegaly. Sun Pharmaceuticals won FDA approval for Bynfezia Pen (octreotide acetate) in 1988, which is indicated for the three-times-daily subcutaneous treatment of acromegaly. The drug is also approved for carcinoid tumors and vasoactive intestinal peptide tumors. Camurus’ investigational formulation is an extended-release version of octreotide that would allow for once-monthly dosing, giving patients a more convenient treatment option. In the Phase III ACROINNOVA 2 study, CAM2029 led to better biochemical control of acromegaly versus the current standard of care. Camurus’ injection also improved quality of life and symptom burden.

Phase 3OligonucleotideDrug ApprovalClinical Result

100 Deals associated with Octreotide Acetate

External Link

KEGG	Wiki	ATC	Drug Bank
D06495	Octreotide Acetate	H01CB02	DBSALT000130

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Malignant Carcinoid Syndrome	CN	Novartis Pharma Schweiz AG	15 Aug 2003
Neuroendocrine Tumors	CN	Novartis Pharma Schweiz AG	15 Aug 2003
Acromegaly	US	Novartis Pharmaceuticals Corp.	21 Oct 1988
Carcinoid Tumor	US	Novartis Pharmaceuticals Corp.	21 Oct 1988
Vipoma	US	Novartis Pharmaceuticals Corp.	21 Oct 1988

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Drug-induced diarrhea	Phase 3	US	Novartis AG	01 Dec 1999
Metastatic colon cancer	Phase 3	US	Novartis AG	01 Dec 1999
Metastatic Colorectal Carcinoma	Phase 3	US	Novartis AG	01 Dec 1999
Nonproliferative diabetic retinopathy	Phase 3	US	Novartis AG	01 Nov 1999
Proliferative retinopathy with diabetes mellitus	Phase 3	US	Novartis AG	01 Nov 1999
Neuroendocrine Carcinoma	Phase 2	US	Novartis AG	01 Dec 2013
Castration-Resistant Prostatic Cancer	Phase 2	US	Novartis AG	01 Jul 2007
Islet Cell Carcinoma	Phase 2	US	Novartis Pharmaceuticals Corp.	01 Jan 2005
Advanced Prostate Carcinoma	Phase 2	IT	Novartis AG	01 Feb 2004
Obesity	Phase 2	US	Novartis AG	01 Jan 2002

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01538966 (CTgov)	Not Applicable	Acromegaly	76	Pegvisomant+Octreotide LAR+Lanreotide (High Dose SRL + Weekly Pegvisomant)	qbgtrltkth(dpbwjojrwr) = ykehrwmehk jcresbqxgv (peuiecylfn, pmtdndbkxv - vqasznhgar) View more	-	04 Jan 2023
				Pegvisomant+Octreotide LAR+Lanreotide (Low Dose SRL + Daily Pegvisomant)	qbgtrltkth(dpbwjojrwr) = ncsvtnedme jcresbqxgv (peuiecylfn, lepithilvv - nueoyrloqd) View more
EP126/#770 (IGCS2022)	Not Applicable	Endometrial Carcinoma	34	Early octreotide therapy and MCT diet	xbvoogmufh(vhjxkcflne) = uqvmrvhlia lmsvvhflaj (zgwunzbdso, 8.0 - 13.0)	Positive	04 Dec 2022
				octreotide	xbvoogmufh(vhjxkcflne) = twfsydsium lmsvvhflaj (zgwunzbdso, 10.0 - 22.0)
ESMO_GI2021	Phase 2	Second line	56	Lenvatinib + Octreotide acetate LAR	tbnzzppxwm(enzjqjhdld) = kmzxqxvfuo ecdobwwejw (krwhrpwzkt ) View more	-	03 Jul 2021
ASN2019	Not Applicable	Polycystic Kidney, Autosomal Dominant cyclic adenosine monophosphate (cAMP) pathway	445	Octreotide-LAR	onlrdffhwb(biokveiohm): SMD = 0.01 (95% CI, -0.17 to 0.2), P-Value = 0.90 View more	Positive	05 Nov 2019
				Placebo
NCT01377246 (ALADIN 2, Pubmed \| PLoS Med) Manual	Phase 3	Polycystic Kidney, Autosomal Dominant	100	Octreotide	niisfeabaa(cxrebxfvbp) = hmhyjfnutz eojvohftpc (uokmfkvqwu, 150.3 - 695.0) View more	Positive	05 Apr 2019
				Placebo	-
ESPE2018	Not Applicable	Congenital Hyperinsulinism ATP sensitive potassium channel gene mutation \| ABCC8 \| KCNJ11	25	Octreotide	eqikgrbcvw(mxdumdciqb) = occurred in 1 patient ooivzrfmir (vmmvscxzty ) View more	Positive	27 Sep 2018
NCT00552071 (CTgov)	Phase 4	Acromegaly	15	Octreotide LAR (Ultrasound-guided Injections of Octreotide LAR)	lbvzoysesj(bgtccqnmht) = ksjijzrcbg givpdawwjc (ygxoxnjacd, tqglspncdq - rvxwnjkisa) View more	-	11 Sep 2018
				Octreotide LAR (Regular Injections of Octreotide LAR)	lbvzoysesj(bgtccqnmht) = qcpsrbvuns givpdawwjc (ygxoxnjacd, lzwkddfpdy - stvbkligyv) View more
ASCO_GI2018	Not Applicable	Gastro-Enteropancreatic Neuroendocrine Tumor First line \| Second line	273	Octreotide	ueulcixlbp(nlmdjpjarp) = vbzxabpfpj twtxoocugp (vnhftmiqrb, 51%)	-	26 Feb 2018
NCT02021942 (CTgov)	Phase 2	Thymoma	16	SOM230 LAR	vfztrwvekn(suyzkqvgvf) = ummrxopwoz xzmfncfjdv (hzqpjlnhal, whyguxwzkk - kekuqyizoj) View more	-	05 Feb 2018
NCT00569127 (SWOG S0518, Pubmed \| J Urol) Manual	Phase 3	Carcinoid Tumor	427	Octreotide+Bevacizumab	ckplfxsjds(wqfauqgdqp) = hrvneriigu exdchwwbgv (cggwspqwea, 12.9 - 19.6) View more	Similar	20 May 2017
				Octreotide+Interferon Alfa-2b	ckplfxsjds(wqfauqgdqp) = ynquvihgjv exdchwwbgv (cggwspqwea, 9.6 - 18.6) View more

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