Effect of Intraoperative Topical Application of a Taurolidine Solution on CIED Related Infections in the Clinical Setting - a Prospective Observational Study With a Restrospective Historical Control

From January 1st 2020, any CIED procedure conducted with adjunct TauroPace™ CIED and pocket irrigation is enrolled in a consecutive manner and followed up in one centre. Follow-up is prospectively.
Before that date any CIED procedure conducted with adjunct antispetic pocket and CIED irrigation is evaluated retrospectively to form a comparable group.

Start Date01 Jan 2020

Sponsor / Collaborator

University of Kiel

[+1]

IRCT20190529043748N1 / RecruitingPhase 1/2IIT

Heparin,vancomycin and Taurolidine effects in prevention of catheter infection in patients hemodialysis

Start Date22 May 2019

Sponsor / Collaborator

Babol University of Medical Sciences

100 Clinical Results associated with Taurolidine

100 Translational Medicine associated with Taurolidine

100 Patents (Medical) associated with Taurolidine

367

Literatures (Medical) associated with Taurolidine

01 Oct 2024·ANNALS OF VASCULAR SURGERY

Article

Author: Kim, Jongwon ; Bae, Miju

OBJECTIVES:

Infection of hemodialysis access is a clinically important concern and can lead to increased morbidity and mortality among patients on hemodialysis. In this study, we aimed to determine whether using taurolidine as an irrigating antiseptic after drainage of pus or removal of infected tissue and graft during surgery decreases the relapse and recurrence of infection.

METHODS:

Between January 2016 and December 2023, 48 episodes in 38 patients hospitalized and treated for hemodialysis access infections were examined. Relapse, recurrence, and mortality of infection were analyzed in patients who received additional taurolidine irrigation versus those who did not. After drainage alone or after total or partial graft removal, all patients received massive irrigation with normal saline. The episodes of infection were examined consecutively during follow-up.

RESULTS:

The majority (97.9%) of hemodialysis access infections were arteriovenous grafts (AVGs) or interposed grafts from native veins. In AVGs, infections occurred primarily after a median of 523 days from the first needling. All prosthetic materials that were the infection foci were removed in 58.3% of the cases, with partial resection and bypass or drainage performed in the remaining cases. The most common pathogen was Staphylococcus aureus (45.8%). After surgical intervention, relapse was observed in 12.5% of the cases and recurrence in 20.8% of the cases. The relapse occurrence was significantly reduced by taurolidine irrigation (odds ratio [OR]: 0.16, 95% confidence interval [CI]: 0.02-0.98, p = 0.05) and the total resection of prosthetic material (OR: 0.07, 95% CI: 0.01-0.70, p = 0.02). Recurrence was significantly decreased by taurolidine irrigation (OR: 0.10, 95% CI: 0.02-0.56, p = 0.01) and increased dramatically in cases with relapse history (OR: 8.50, 95% CI: 1.69-42.76, p < 0.01). Finally, male sex (hazard ratio: 7.01, 95% CI: 1.19-41.40, p = 0.03) and AVG (hazard ratio: 4.49, 95% CI: 1.01-20.01, p = 0.05) were significantly associated with increased overall mortality in infected hemodialysis access.

CONCLUSIONS:

Additional taurolidine irrigation after surgical resection significantly reduced the relapse and recurrence of infection in hemodialysis access. Taurolidine appears to be a safe and useful antiseptic for the control of hemodialysis access infection.

01 Oct 2024·JOURNAL OF HOSPITAL INFECTION

Article

Author: Fiocco, M ; van der Bruggen, J T ; van de Wetering, M D ; Frakking, F N J ; van de Ven, C P ; van der Steeg, A F W ; van den Bosch, C H ; Wijnen, M H W A ; Loeffen, Y G T

BACKGROUND:

Taurolidine-citrate(-heparin) lock solutions (TCHL) are suggested as a promising and safe method for the prevention of central line-associated bloodstream infections (CLABSI).

AIM:

To investigate the efficacy TCHL for the prevention of CrLABSI in paediatric oncology patients.

METHODS:

An assessor blinded randomized controlled trial at the Princess Máxima Centre for paediatric oncology, the Netherlands, was performed from 2020-2023. Paediatric oncology patients receiving a tunnelled central venous access device (CVAD) were eligible. A total of 462 patients was required to compare the TCHL to the heparin-only lock (HL). Patients were followed-up for the first 90 days after CVAD insertion. The primary outcome was the incidence of the first CLABSI from CVAD insertion until the end of follow-up. Intention-to-treat and per-protocol analyses were performed.

FINDINGS:

In total, 232 were randomized in the HL and 231 in the TCHL-group. A total of 47 CLABSIs were observed. The intention-to-treat analysis showed that a CLABSI was observed in 26 (11.2%) of the HL-group patients versus 21 (9.1%) of the TCHL-group patients; incidence rate ratio (IRR) of 0.81 (CI95%0.46-1.45), in favour of the TCHL-group. The per-protocol analysis showed that a CLABSI was observed in 10 (7.9%) of the HL-group patients versus 6 (4.8%) of the TCHL-group patients; IRR of 0.59 (CI95%0.21-1.62) in favour of the TCHL-group. Adverse events were more common in the TCHL-group but rarely reported.

CONCLUSION:

No difference was detected between the TCHL and HL in the incidence of CLABSI in paediatric oncology patients.

TRIAL REGISTRATION NUMBER:

ClinicalTrials.gov NCT05740150.

09 Jul 2024·ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

In vitro activity of taurolidine against clinical Candida auris isolates: relevance to catheter-related bloodstream infections

Article

Author: Crandon, Jared L ; Jenkins, Stephen G ; Arends, S J Ryan ; Hurlburt, Elizabeth ; Tan, Xing ; Pfaffle, Antony ; Reidenberg, Bruce E ; Rhomberg, Paul R

ABSTRACT:

Candida auris is an evolving and concerning global threat. Of particular concern are bloodstream infections related to central venous catheters. We evaluated the activity of taurolidine, a broad-spectrum antimicrobial in catheter lock solutions, against 106 C . auris isolates. Taurolidine was highly active with a MIC 50 /MIC 90 of 512/512 mg/L, over 20-fold lower than lock solution concentrations of ≥13,500 mg/L. Our data demonstrate a theoretical basis for taurolidine-based lock solutions for prevention of C. auris catheter-associated infections.

News (Medical) associated with Taurolidine

30 Oct 2024

·www.globenewswire.com

CorMedix Inc. Reports Third Quarter and Nine Month 2024 Financial Results and Provides Business Update

‒ Q3 2024 Net Revenue of $11.5 million ‒ ‒ Commercializing DefenCath with Four of Top Five US Dialysis Providers ‒ ‒ Conference Call Scheduled for Today at 8:30 a.m. Eastern Time ‒ BERKELEY HEIGHTS, N.J., Oct. 30, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced financial results for the third quarter and nine months ended September 30, 2024 and provided an update on its business. Recent Corporate Highlights: CorMedix today reports its first full quarter of DefenCath sales since commencing outpatient launch in July 2024. The Company reported net sales of $11.5 million for the third quarter, largely driven by successful implementation by an initial anchor customer, a mid-sized dialysis operator.During the third quarter, CorMedix announced commercial agreements with a large dialysis operator and two new mid-sized dialysis operators and now has commercial agreements providing access to roughly 60% of outpatient dialysis centers in the US. CorMedix is actively working with these customers to initiate DefenCath utilization in the 4th quarter of 2024.The Company has started to see pull-through of units to inpatient facilities as health systems begin to complete P&T reviews and provide patients access to DefenCath. CorMedix remains focused on building brand advocacy with key opinion leaders in this setting of care.Following FDA feedback, the Company is in the final stages of amending the clinical study protocol for Total Parenteral Nutrition, or TPN, and anticipates FDA submission by mid-November to align with our plans to operationalize the study in the first half of 2025. In addition, CorMedix remains on track with a real-world evidence study, the pediatric hemodialysis study, and the expanded access program for DefenCath.Cash and short-term investments, excluding restricted cash, at September 30, 2024 amounted to $46.0 million. Joe Todisco, CorMedix CEO, commented, “I am excited about the Company’s recent progress as we execute on our launch objectives and increase patient access to DefenCath across settings of care. Having established patient access at roughly 60% of outpatient dialysis clinics in the US, I’m optimistic about the opportunity for DefenCath as we shift focus toward 2025. We have several important clinical initiatives commencing early next year aimed at expanding indications for DefenCath beyond adult hemodialysis, providing an important catalyst for future growth.” Third Quarter and Nine Months 2024 Financial Highlights For the third quarter of 2024, CorMedix recorded $11.5 million in net revenue from sales of DefenCath for the first full quarter sales since DefenCath was launched in 2024. For the third quarter of 2024, CorMedix recorded a net loss of $2.8 million, or $0.05 per share, compared with a net loss of $9.7 million, or $0.17 per share, in the third quarter of 2023, a decrease of $6.9 million or 72%. The decrease in net loss was driven primarily by the launch of DefenCath and net sales in the period. Operating expenses in the third quarter 2024 were $14.1 million, compared with $10.5 million in the third quarter of 2023, an increase of approximately 34%. The increase was driven by higher selling and marketing (S&M) and general and administrative (G&A) expenses which increased approximately 66% and 76%, respectively. These increases were partially offset by a decrease in research and development (R&D) expenses of approximately 73%. The increases in S&M and G&A were primarily driven by increased marketing efforts and the hiring of sales force, medical affairs and marketing personnel in support of the commercial launch of DefenCath. Additionally, as a result of the post FDA approval commercial operations, costs related to medical affairs and certain personnel expenses that supported R&D efforts prior to the FDA approval of DefenCath have been recognized primarily in G&A expense during the three months ended September 30, 2024. For the nine months ended September 30, 2024, CorMedix recorded a net loss of $31.4 million, or $0.54 per share, compared with a net loss of $31.6 million, or $0.65 per share, in the same period in 2023, a decrease of $0.2 million, or 0.6%, driven primarily by $12.3 million in net revenue and proceeds received from the sale of our unused New Jersey net operating losses, offset by an increase in operating expenses. Operating expenses in the first nine months of 2024 were $45.5 million, compared to $33.3 million during the comparative period in 2023, an increase of approximately 37%. This increase was primarily due to costs related to marketing and commercial activities in support of the launch activities of DefenCath, partially offset by a decrease in R&D expenses, attributable to the marketing approval of DefenCath. The Company reported cash and short-term investments of $46.0 million as of September 30, 2024, excluding restricted cash. The Company believes that it has sufficient resources to fund operations for at least twelve months from the issuance of the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024. Conference Call Information The management team of CorMedix will host a conference call and webcast today, October 30, 2024, at 8:30AM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows: Wednesday, October 30th @ 8:30am ET Domestic: International:Webcast: 1-844-481-25571-412-317-0561Webcast Link About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath® (taurolidine and heparin) which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and in outpatient settings in July 2024. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. For more information visit: www.cormedix.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact:Dan FerryManaging DirectorLifeSci Advisorsdaniel@lifesciadvisors.com(617) 430-7576 CORMEDIX INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(Unaudited) For the Three Months Ended September 30, For the Nine Months Ended September 30, 2024 2023 2024 2023 Revenue Revenue, net$11,456,115 $- $12,262,234 $- Cost of revenues (686,598) - (2,014,975) - Gross profit (loss) 10,769,517 - 10,247,259 - Operating Expenses Research and development (727,119) (2,663,976) (2,215,551) (10,866,236)Selling and marketing (6,748,900) (4,058,428) (20,472,961) (9,955,651)General and administrative (6,580,834) (3,744,879) (22,851,144) (12,467,157)Total operating expenses (14,056,853) (10,467,283) (45,539,656) (33,289,044)Loss from Operations (3,287,336) (10,467,283) (35,292,397) (33,289,044)Other Income (Expense) Total other income 510,524 722,929 2,503,203 1,703,846 Net Loss Before Income Taxes (2,776,812) (9,744,354) (32,789,194) (31,585,198)Tax benefit - - 1,394,770 - Net Loss (2,776,812) (9,744,354) (31,394,424) (31,585,198)Other Comprehensive Income (Loss) Total other comprehensive income (loss) 3,389 (6,298) (4,988) 1,656 Other Comprehensive (Loss) Income$(2,773,423)$(9,750,652)$(31,399,412)$(31,583,542)Net Loss Per Common Share – Basic and Diluted $(0.05)$(0.17)$(0.54)$(0.65)Weighted Average Common Shares Outstanding – Basic and Diluted 58,825,221 56,553,174 57,986,190 48,715,585 CORMEDIX INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEET DATA September 30, 2024 December 31, 2023 (Unaudited) (Audited) ASSETS Cash, cash equivalents and restricted cash$35,391,222 $43,823,192 Short-term investments$10,743,562 $32,388,130 Total Assets $77,586,194 $82,059,957 Total Liabilities $18,873,926 $11,917,528 Accumulated deficit$(353,094,437)$(321,700,013) Total Stockholders’ Equity $58,712,268 $70,142,429 CORMEDIX INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(Unaudited) For the Nine Months Ended September 30, 2024 2023 Cash Flows from Operating Activities: Net loss$(31,394,424) $(31,585,198)Net cash used in operating activities (45,000,117) (27,663,786)Cash Flows Used in Investing Activities: Net cash provided by (used in) investing activities 21,534,874 (17,659,477)Cash Flows from Financing Activities: Net cash provided by financing activities 15,033,751 55,449,154 Net (Decrease) Increase in Cash and Cash Equivalents (8,431,970) 10,126,276 Cash and Cash Equivalents and Restricted Cash - Beginning of Period 43,823,192 43,374,745 Cash and Cash Equivalents and Restricted Cash - End of Period$ 35,391,222 $ 53,501,021

Drug ApprovalFinancial Statement

24 Oct 2024

·www.globenewswire.com

CorMedix Inc. Announces New Data at ASN Kidney Week 2024

Study highlights significant healthcare challenges and costs associated with bloodstream infections (BSIs) in patients receiving chronic hemodialysis through central venous catheters (HD-CVCs)BERKELEY HEIGHTS, N.J., Oct. 24, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing therapeutic products for life-threatening diseases and conditions, today announced new hospital admission and health economic data presented at the American Society of Nephrology Kidney Week 2024 in San Diego, CA from October 24 - 27. This retrospective analysis, using data from the Premier Healthcare Database, evaluated hospital admissions from 2020 to 2022 to examine the demographics, clinical characteristics, and outcomes of adult HD-CVC patients hospitalized for bloodstream infections (BSIs). Among the 91,448 unique patients admitted, 25% (N=22,902) presented with a BSI. Key findings include: Patient Demographics: The patient population was 58.2% white, 27.1% black, and 56.6% male, with 59.3% aged 60 years or older. A substantial number of patients lived in vulnerable communities, with 47% residing in the most socioeconomically disadvantaged quartile of neighborhoods nationwide.Hospitalization Outcomes: The median length of stay for BSI-related hospitalizations was 16 days, with 53.8% of admissions involving time in the ICU (median stay: 8 days). The study reported an all-cause in-hospital mortality rate of 10.3%.Comorbidities: Patients had extensive comorbidities, with 87.8% having three or more Charlson comorbidity conditions, and 42.6% had six or more.Economic Impact: The median total cost of admission was $157,000, with $65,000 attributed to ICU care alone. Healthcare utilization, including readmissions (26.8% within 90 days), placed a significant financial burden resulting from these infections. "This study underscores the critical need for improved prevention strategies and interventions in the management of catheter-related bloodstream infections (CRBSIs) among hemodialysis patients," says CorMedix CEO, Joseph Todisco. "With one in four patients admitted for a bloodstream infection and a 10% in-hospital mortality, along with median hospitalization costs of $157,000, reducing both the incidence and financial impact of these infections is critical." This poster presentation will be made available on the Company’s website at www.cormedix.com/publications-and-presentations. About CorMedixCorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath® (taurolidine and heparin), which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and in outpatient settings in July 2024. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. For more information visit: www.cormedix.com. Forward-Looking StatementsThis press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “will,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would,” and similar expressions or variations intended to identify forward-looking statements. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, and readers are directed to the Risk Factors identified in CorMedix’s filings with the SEC, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and such forward-looking statements speak only as of the date of this press release. Investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law. Investor Contact:Dan FerryManaging DirectorLifeSci Advisorsdaniel@lifesciadvisors.com(617) 430-7576

Drug ApprovalClinical Result

23 Oct 2024

·www.globenewswire.com

CorMedix Inc. to Report Third Quarter 2024 Financial Results and Provide a Corporate Update on October 30, 2024

BERKELEY HEIGHTS, N.J., Oct. 23, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced that it will report its financial results for the third quarter ended September 30, 2024, before the market opens on Wednesday, October 30, 2024, and will host a corporate update conference call at 8:30am Eastern Time. Wednesday, October 30th @ 8:30am EDTDomestic:1-844-481-2557International:1-412-317-0561Webcast:Webcast Link About CorMedixCorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath® (taurolidine and heparin), which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and in outpatient settings in July 2024. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations. For more information visit: www.cormedix.com. Investor Contact:Dan FerryManaging DirectorLifeSci Advisorsdaniel@lifesciadvisors.com (617) 430-7576

Drug ApprovalFinancial Statement

100 Deals associated with Taurolidine

External Link

KEGG	Wiki	ATC	Drug Bank
D07146	Taurolidine	B05CA05	DB12473

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Bacterial Infections	-	-	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neuroblastoma	Preclinical	US	CorMedix, Inc.	22 Sep 2024
Osteosarcoma	Preclinical	US	CorMedix, Inc.	22 Sep 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ISN WCN2023	Not Applicable	Peritoneal dialysis-associated peritonitis	23	Intra-catheter Taurolidine (TauroLockTM-U25000)	jblgywarxm(pqvsmzdnly) = kzasoyeaxl jflmljgurf (ixhralaetd ) View more	Positive	01 Mar 2023
ASN2016	Not Applicable	-	-	Taurolidine Citrate with Urokinase (T/U)	dmfgjdugxy(dabwywtfwb) = qmefrjlgfw ovhfpbfoxv (bohczssaew ) View more	Positive	15 Nov 2016
				Taurolidine Citrate with Heparin (T/Hep)	dmfgjdugxy(dabwywtfwb) = fsgqoixbza ovhfpbfoxv (bohczssaew ) View more
ASN2016	Not Applicable	Catheter dysfunction	25	Taurolidine-urokinase-U25.000 (T/U) catheter lock	uknswokdps(gzjbrghxok) = No adverse events reported during study period nrvavwucuk (bbkpqhalkn )	Positive	15 Nov 2016
				Heparin 5000 unit/mL
SP524 (ERA2016)	Not Applicable	-	-	Taurolidine citrate with heparin (Taurolock/Hep)	twvusesdul(henspmjktj) = skfvvuaiqw qcvkapskiq (uzasewssib ) View more	Positive	14 May 2016
				Taurolidine citrate with Urokinase (Taurolock/U)	twvusesdul(henspmjktj) = hkiquorzjo qcvkapskiq (uzasewssib ) View more
SITC2015	Not Applicable	Melanoma	5	Dendritic Cell Vaccine + High Dose IL-2 + Taurolidine	wlxgmvwcxn(bnsgrnpjqp) = lnvpwnpfmq nfhkrshfyd (xmdbnlolxh )	Positive	04 Nov 2015
				High Dose IL-2	wlxgmvwcxn(bnsgrnpjqp) = bozmrvtmzy nfhkrshfyd (xmdbnlolxh )
ASN2013	Not Applicable	Catheter-Related Infections	38	Taurolidine 2%	oxbfqakzen(ccljpmzoyv) = one patient in heparin group had symptoms strongly suggestive of CRBSI, however refused further work up. The point incidence rates of CRBSI was 2.7% or 1.1 per 1000 catheter days. 5 patients in taurolidne group and 4 in heparin group continued HD beyond 30 days till they were shifted to AVF, except one in taurolidne group who continued on the same catheter and died of CRBSI on 100 th day hxgmcaxzko (vvynzbhiqr ) View more	Negative	05 Nov 2013
				Heparin

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