A prospective, randomized controlled trial of fibrinogen concentrate (FC) plus standard of care versus standard of care alone in adult trauma patients with major bleeding or presumed major bleeding is developed to evaluate the efficacy and safety of prehospital administration of FC in trauma patients with suspected hypofibrinogenemia and active bleeding or presumed to be bleeding.
The main endpoints are:
1. Plasma fibrinogen levels in the first blood sample drawn at the patient's arrival at the trauma room and/or similar emergency bay dedicated to trauma and reanimation above the critical threshold of 2.0 g/l. As fibrinogen decreases early in trauma, its deficiency predicts massive bleeding and death.
2. Administration feasibility of FC within the prehospital setting.
Patients will be randomly assigned to receive either standard trauma care or standard trauma care plus administration of FC.

Start Date01 Jan 2025

Sponsor / Collaborator-

CTRI/2024/09/073878

/ Not yet recruitingPhase 3IIT

Evaluation of the effect of fibrinogen on peripartum hemorrhage in Placenta accreta spectrum (PAS) disorders, a double blind randomized controlled trial. - NIL

Start Date24 Sep 2024

Sponsor / Collaborator-

EUCTR2022-001759-17-DE

/ Not yet recruitingPhase 3

A multicenter, randomized, double-blind, placebo-controlled, parallel, phase 3 study to assess the efficacy and safety of fibrinogen concentrate (FGTW) in the management of bleeding in patients undergoing complex cardiac surgery (involving CPB)

Start Date15 Mar 2023

Sponsor / Collaborator

Laboratoire Français du Fractionnement et des Biotechnologies

100 Clinical Results associated with Fibrinogen Concentrate (Human)

100 Translational Medicine associated with Fibrinogen Concentrate (Human)

100 Patents (Medical) associated with Fibrinogen Concentrate (Human)

556

Literatures (Medical) associated with Fibrinogen Concentrate (Human)

01 Jun 2025·Pediatric Cardiology

Effects of Fibrinogen Concentrate Supplementation on Postoperative Bleeding in Infants Undergoing Complex Cardiac Surgery

Article

Author: Vitale, Vincenzo ; Benegni, Simona ; Giorni, Chiara ; Rizza, Alessandra ; Pergolizzi, Carola ; Iodice, Francesca Giovanna ; Olivieri, Andrea Maria ; Di Chiara, Luca ; Marinari, Eleonora ; Raggi, Valeria

The use of allogeneic blood products to restore hemostasis during pediatric cardiac surgery is associated with major risks. Consequently, there has been a growing interest in new patient blood management strategies, such as those based on the use of fibrinogen concentrate (FC). Accumulating evidence has shown FC supplementation to be safe and effective. Nevertheless, no guidelines are available on using FC in the pediatric setting, and few objective evaluations have been provided in clinical practice. The endpoint of this monocenter retrospective study was the hemostatic effect of additional FC in infants undergoing complex cardiac surgery with cardiopulmonary bypass to manage persistent clinically relevant bleeding. After weaning from cardiopulmonary bypass and after protamine administration, patients were transfused with conventional allogeneic products such as packed red blood cells, fresh frozen plasma (FFP), and platelets. In the case of redo surgery, according to the institutional protocol, patients also received tranexamic acid. In case of clinically persistent relevant bleeding, according to the anesthesiologist's judgment and thromboelastography, patients received FC supplementation (group with FC) or further FFP transfusions without receiving FC supplementation (group without FC). The primary endpoint was the hemostatic effects of FC. Secondary endpoints were the functional hypofibrinogenemia threshold value (expressed as maximum amplitude fibrinogen, MA-Fib) and postoperative MA-Fib, fibrinogenemia, intraoperative transfusions, and adverse events (AEs). In total, 139 patients who underwent cardiac surgery with CPB and aged less than 2 years were enrolled: 70 patients received allogeneic blood products and FC supplementation (group FC); 69 patients received allogeneic products without FC supplementation (group without FC). Patients that received FC supplementation were characterized by a significantly longer time of extracorporeal circulation (p < 0.001) and aortic cross-clamping (p < 0.001), a significantly lower minimum temperature (p = 0.011), increased use of concentrated prothrombin complex (p = 0.016) and tranexamic acid (p = 0.010), and a significantly higher amount of packed red blood cells, platelets (p < 0.001) and fresh frozen plasma (p = 0.03). Postoperative bleeding and severe bleeding were not statistically different between patients treated with FC and those not treated with FC supplementation (p = 0.786 and p = 0.695, respectively); after adjustment, a trend toward reduced bleeding can be observed with FC (p = 0.064). Overall, 88% of patients with severe bleeding had MA-Fib < 10 mm; a moderate association between severe bleeding and MA-Fib (odds ratio 1.7, 95% CI 0.5-6.5, p = 0.425) was found. Increased MA-Fib and postoperative fibrinogen were higher in the FC group (p = 0.003 and p < 0.001, respectively) than in FFP. AEs in the FC group were comparable to those observed in less complicated surgeries. Our results suggest a potential role of FC in complex surgery in maintaining postoperative bleeding at a level comparable to less complicated surgical procedures and favoring the increase in postoperative MA-Fib and fibrinogen.

01 May 2025·Advances in Therapy

A Multicenter Single-Arm Study of Switching to Ferric Citrate Hydrate for Iron Deficiency Anemia in Patients Intolerant to Oral Iron: RIO-SWITCH

Article

Author: Wada-Hiraike, Osamu ; Osuga, Yutaka ; Iriyama, Takayuki ; Mitobe, Yuko ; RIO-SWITCH Consortium ; Mori-Uchino, Mayuyo ; Maruyama, Aya

INTRODUCTIONTreatment interruptions due to adverse drug reactions (ADRs) are common in iron deficiency anemia (IDA). We evaluated medication completion rates and quality of life (QoL) changes in patients with IDA after starting ferric citrate hydrate (FCH) treatment.METHODSThis multicenter, open-label, uncontrolled, single-arm comparative study included 30 Japanese female patients with IDA who experienced nausea and/or vomiting (N/V) with previous oral iron preparations. Patients received FCH 500 mg orally daily (< 1000 mg/day). Those with hemoglobin levels ≥ 11.0 g/dl completed the study at week 4; others continued until week 8. The primary endpoint was medication completion rate. Secondary endpoints included medication compliance rate, treatment satisfaction scores, and QoL scores and changes.RESULTSThirty patients initiated and completed treatment; 24 reached ≥ 11.0 g/dl hemoglobin at week 4 and ended treatment, while 6 continued until week 8. The medication compliance rate was 93.92% ± 8.11% (mean ± standard deviation [SD]), and the completion rate was 100.0% (95% confidence interval 88.4-100.0%). Questionnaire findings revealed that the most severe nausea score decreased from 5.7 ± 2.4 to 1.7 ± 2.1 (mean ± SD), N/V incidence decreased from 100.0 to 63.3%, and patients reporting that N/V did not interfere with daily life increased from 6.7 to 52.6% following the switch to FCH. Twenty-four patients (80.0%) reported a satisfactory experience with FCH versus their previous oral iron preparation. Scores for all eight subscales of the Short-Form 36-Item Health Survey v2 improved, with significant increases in six. Nine ADR events occurred in six patients (20.0%), including nausea in three (10.0%); none were serious or resulted in treatment discontinuation.CONCLUSIONFCH treatment exhibited a satisfactory medication completion rate in patients with IDA. Switching to FCH reduced N/V incidence and improved N/V and QoL severity compared with previous oral iron preparations.TRIAL REGISTRATIONjRCTs031210634. Registration date: March 01, 2022.

01 May 2025·European Journal of Anaesthesiology

A prospective cohort substudy within the FIBrinogen CONcentrate randomised control trial

Article

Author: Tibby, Shane M ; Hunt, Beverley J ; Parmar, Kiran ; Harris, Julia ; Siemens, Kristina

BACKGROUNDFibrinolytic activity contributes to bleeding after cardiopulmonary bypass (CPB).OBJECTIVEOur objectives were, in a group of infants undergoing cardiac surgery with CPB: to document the extent of peri-operative fibrinolysis using rotational thromboelastometry (ROTEM) and standard biomarkers; to compare the agreement between these fibrinolytic measures; to assess whether fibrinolytic activity is associated with early postoperative mediastinal bleeding and assess whether supplementation with fibrinogen concentrate affected fibrinolysis.DESIGNProspective cohort, mechanistic substudy, nested within the FIBrinogen CONcentrate (FIBCON) randomised controlled trial.SETTINGSingle centre, tertiary paediatric cardiac surgery and paediatric intensive care units.PATIENTSNinety infants (median age 6.3 months) undergoing cardiac surgery, who all received routine intra-operative tranexamic acid. The infants were randomised to receive either an individualised dose of fibrinogen concentrate (n = 60) or placebo (n = 30) during CPB.MAIN OUTCOME MEASURESWe measured the ROTEM variable maximum clot lysis (ML), and fibrinolytic biomarkers including plasmin-antiplasmin (PAP) and tissue plasminogen activator antigen (tPA-Ag). Blood was sampled pre-CPB, on-CPB and post-CPB, and 4 h after PICU admission.RESULTStPA-Ag, PAP and ROTEM ML increased significantly after CPB despite the use of tranexamic acid. The two fibrinolytic biomarkers t-PA and PAP, correlated (P = 0.001) but neither correlated with ROTEM ML. Early postoperative blood loss was inversely associated with PAP levels. Each 100 μg l−1 rise in PAP was associated with a 7.9% reduction in mean blood loss. Fibrinogen concentrate supplementation as expected did not affect tPA-Ag but was temporally associated with an increase in PAP levels and a decrease in ROTEM fibrinolytic activity.CONCLUSIONFibrinolysis is activated after paediatric cardiac CPB surgery as indicated by increased tPA-Ag and ROTEM ML. The substantial increase in tPA-Ag post-PICU admission is probably accompanied by a similar rise of plasminogen activator inhibitor 1 (PAI-1) as part of the acute phase response to surgery, thereby limiting clinical fibrinolysis. Supplementation of fibrinogen concentrate was associated with increased PAP activity and less clinical bleeding, consistent with the known role for fibrinogen in being a substrate for plasmin.TRIAL REGISTRATIONISCTRN:50553029, Eudract:2013-003532-68.

News (Medical) associated with Fibrinogen Concentrate (Human)

14 Feb 2024

·www.fiercepharma.com

Grifols readies US, EU approval push for blood clot treatment after phase 3 success

BT524 can be administered to “patients on the operating table immediately," Grifols explained. Grifols is readying an approval run at U.S. and European regulators on the back of a phase 3 win for the Spanish plasma medicine producer's concentrated form of a blood clotting factor. The product, dubbed BT524, is a concentrated form of fibrinogen, a glycoprotein that is essential for blood clot formation and stops excessive bleeding resulting from injuries or surgery. Grifols was testing BT524 in a late-stage study of patients with acquired fibrinogen deficiency (AFD), which it described as an “underserved growth market.” The Barcelona, Spain-based company announced this morning that the product had met the study’s primary endpoint, demonstrating its noninferiority to standard of care when it came to reducing blood loss in patients with AFD who underwent spinal or abdominal surgery, while also “maintaining an excellent safety profile.” Specifically, mean blood loss was 1,444 mL among the BT524 cohort compared with 1,735 mL among patients who received standard of care. It meant patients receiving Grifols’ product lost an average of 291 mL less blood. AFD usually occurs during surgery when a patient’s body contains insufficient fibrinogen to arrest bleeding. It is typically treated with a plasma extract called cryoprecipitate or fresh frozen plasma, which both contain fibrinogen. However, both of these treatment options contain various other unneeded proteins and elements, meaning that large volumes are required to ensure the patient receives sufficient fibrinogen, Grifols explained in the release. They also need to be thawed before use, which is not only time-consuming but can put patients’ lives at risk, the company added. In contrast, BT524 can be administered to “patients on the operating table immediately,” who will only receive the fibrinogen necessary to prevent hemorrhaging, Grifols explained. The company’s plan is to kick off the approval process in both Europe and the U.S. in the fourth quarter of the year. If successful, it would mark the first fibrinogen concentrate approved for AFD in the U.S., Grifols noted. “The positive results for fibrinogen are an important milestone and strengthen a Grifols innovation strategy that’s diversified across plasma and non-plasma, balanced between internal and external investments, and includes both shorter- and longer-term development cycles,” Grifols’ chief operating officer, Victor Grifols Deu, said in the release. While Grifols has its eye on the first fibrinogen concentrate approval for AFD in the U.S., its competitors have had more luck getting their own versions to market for congenital fibrinogen deficiency. CSL Behring got RiaSTAP approved in that indication as far back as 2009, while Switzerland’s Octapharma followed suit with Fibryga in 2017. Since then, Fibryga has also received approval to treat AFD across Europe off the back of a phase 2 study. Meanwhile, Grifols is in the midst of an ongoing legal battle with Gotham City Research after the New York hedge fund accused the company of wrongful accounting practices.

Drug ApprovalClinical ResultPhase 3Phase 2

11 Jun 2021

·www.biospace.com

Fibrinogen Concentrate Market Size to Reach USD 4.19 Billion in 2028, Says Reports and Data

Increasing preference for fibrinogen concentrate over fresh-frozen plasma, rising incidence of bleeding disorders, and increasing number of fibrinogen product approvals are some key factors driving market growth Market Size – USD 2.61 Billion in 2020, Market Growth – at a CAGR of 6.1%, Market Trends – Rising R&D investment to accelerate development of advanced fibrinogen products The global fibrinogen concentrate market size is expected to reach USD 4.19 Billion in 2028 at a CAGR of 6.1%, according to the latest report by Reports and Data. Increasing R&D activities to develop new therapies for bleeding disorders, rising demand for fibrinogen concentrates to treat congenital deficiencies, and high incidence of bleeding disorders across the globe are key factors expected to drive market revenue growth over the forecast period. In addition, increasing number of advanced and innovative in pipeline to treat bleeding disorders is also expected to contribute to revenue growth of the market going ahead. Fibrinogen concentrate is a lyophilized and purified human plasma fibrinogen and is widely used as an alternative to traditional sources of fibrinogen, which is a natural blood protein playing a vital role in coagulation process. Fibrinogen concentrate has been extensively used and recommended for bleeding disorders and acquired coagulation disorders in several countries across the globe as it significantly improves blood clot firmness and minimizes the need for postoperative transfusion. Fibrinogen concentrate can either be plasma-derived or a recombinant and is often used for afibrinogenemia and dysfibrinogenemia. Increasing research is being carried out across the globe to expand its application scope to use it for conditions such as hemorrhage resuscitation. This is expected to contribute to revenue growth of the market going ahead. New product launches and approvals of fibrinogen concentrates are also expected to be a key factor driving market growth. In addition, increasing focus of key players on developing advanced fibrinogen concentrates to treat bleeding disorders is also a key market growth driving factor. However, adverse reactions associated with fibrinogen concentrate such as arterial thrombosis, dyspnea, nausea, and others are expected to hamper market growth to a certain extent over the forecast period. Access Free sample PDF Copy of the Report @ Some Key Highlights from the Report: Human fibrinogen type segment is expected to account for largest revenue share in the global market over the forecast period owing to increasing need for fibrinogen concentrate to treat bleeding disorders and congenital coagulation deficiencies. Congenital fibrinogen deficiency segment is expected to register robust revenue CAGR over the forecast period owing to high incidence of hemophilia, rising rate of bleeding disorders, proven safety and efficiency of fibrinogen concentrates and rapid advancements in fibrinogen products. North America is expected to dominate other regional markets over the forecast period owing to increasing geriatric population and high rate of bleeding disorders, advancements in diagnostics and therapeutics, and robust presence of key players in the region. Major companies in the market include CSL Behring, Baxter, Johnson & Johnson (Ethicon), LFB Group, ProFibrix BV (The Medicines Company), Shanghai RAAS, Jiangxi Boya Bio-Pharmaceutical, Hualan Biological Engineering, Harbin Pacific Biopharmaceutical, and Greencross. In November 2019, Octapharma AG announced approval for use of fibryga, which is a lyophilised human fibrinogen concentrate for intravenous infusion, in treatment of acquired fibrinogen deficiency in 15 European countries. Buy now your Exclusive copy of Report @ For the purpose of this report, Reports and Data has segmented the global fibrinogen concentrate market on the basis of type, application type, and region: Type Outlook (Revenue, USD Billion; Volume in Tons, 2018–2028) Human Animal Application Type Outlook (Revenue, USD Billion; Volume in Tons, 2018–2028) Congenital Fibrinogen Deficiency Surgical Procedures Request for Custom Research @ Regional Outlook (Revenue, USD Billion; Volume in Tons, 2018–2028) North America U.S. Canada Mexico Europe Germany U.K. France Italy BENELUX Rest of APAC Asia Pacific China India Japan South Korea Rest of APAC Latin America Brazil Rest of Latin America Middle East & Africa U.A.E. Saudi Arabia South Africa Rest of MEA Explore Reports and Data's Prime Analysis of the global Pharmaceutical & Healthcare Industry: Hemostasis Analyzers Market Analysis, By Product (Laboratory analyzer, POC testing,) By Test Type (Prothrombin Time, Fibrinogen, Activated Partial and others) By Technology Type (Mechanical and others) By End-Use (Diagnostic Centers, Hospitals, and others), Forecasts to 2026 Product (Revenue, USD Million; 2016-2026) Bovine Blood Plasma Derivatives Market Size, Share & Trends, By Type (Bovine Serum, FBS, Bovine Serum Albumin, Fibrinogen, Protein Ingredient, Others), By Application (Scientific Research, Industrial Production, Feed, Others), And Regional Forecasts To 2027 Coagulation Analyzers Market Size, Share & Analysis, By Product, By Technology (Mechanical, Electrochemical) By Test Types (APTT, D-Dimer, Fibrinogen, PT) By End Use (Hospitals, Research Institutes), And Segment, Forecasts To 2028 About Reports and Data Reports and Data is a market research and consulting company that provides syndicated research reports, customized research reports, and consulting services. Our solutions purely focus on your purpose to locate, target and analyze consumer behavior shifts across demographics, across industries and help client’s make a smarter business decision. We offer market intelligence studies ensuring relevant and fact-based research across a multiple industries including Healthcare, Technology, Chemicals, Power and Energy. We consistently update our research offerings to ensure our clients are aware about the latest trends existent in the market. Reports and Data has a strong base of experienced analysts from varied areas of expertise. Contact Us: John W Head of Business Development Reports and Data | Web: Direct Line: +1-212-710-1370 E-mail: sales@reportsanddata.com Read Full Press Release:

100 Deals associated with Fibrinogen Concentrate (Human)

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hemorrhage	United States	CSL Behring GmbH	16 Jan 2009

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Coronary Artery Disease	Phase 1	United States	CSL Behring LLC	01 Jan 2011
Heart Valve Diseases	Phase 1	United States	CSL Behring LLC	01 Jan 2011
Acquired fibrinogen deficiency	Phase 1	-	CSL Behring LLC	01 Oct 2009
Afibrinogenemia	Phase 1	-	CSL Behring LLC	01 Oct 2009
Hemorrhage	Phase 1	-	CSL Behring LLC	01 Oct 2009
Heart Diseases	Preclinical	Italy	CSL Behring LLC	01 Nov 2011
Acquired fibrinogen deficiency	Preclinical	-	CSL Behring LLC	01 Oct 2009
Afibrinogenemia	Preclinical	-	CSL Behring LLC	01 Oct 2009
Hemorrhage	Preclinical	-	CSL Behring LLC	01 Oct 2009
Aortic Aneurysm	Preclinical	Germany	CSL Behring LLC	01 Jun 2008

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03932240 (CTgov)	Phase 3	-	36	Fibrinogen Concentrate (FC) (Fibrinogen Concentrate (FC))	butfldpkja(nwtzghgttd) = hsxcngobrz auvzesuvxf (aepdlpwmah, gqirsnwgul - qcciemtfic) View more	-	20 Mar 2023
				Cryoprecipitate (Cryoprecipitate)	butfldpkja(nwtzghgttd) = bnsgkmqpcz auvzesuvxf (aepdlpwmah, qrrfhsmzcs - myognzujgg) View more
NCT02822599 (RiaSTAP, CTgov)	Phase 4	Hemorrhage \| Afibrinogenemia	30	RiaStAP (RiaSTAP)	iucvzvngir(ofluxvpuei) = lmmgubueqk ohhuxswhaw (pdzbscdcmm, eofooiwdug - uqsddzybmu) View more	-	16 Sep 2021
				Saline (Saline)	iucvzvngir(ofluxvpuei) = ncpmckobkf ohhuxswhaw (pdzbscdcmm, xsvutbmzei - pqsnfzftzo) View more
ISTH2020	Not Applicable	Thrombocytopenia	-	Fibrinogen concentrate	cnscntjioz(kryyagaqvc) = udleoxcbqu korviohlnb (ttfxjkzpud )	-	12 Jul 2020
NCT01623531 (CTgov)	Phase 3	Intraoperative Complications	62	Fibrinogen (RiaSTAP)	qvuqbamnei(iboqxbvvei) = rbusbhthqk kvhsbsbskk (gfnvfjdohx, zbpszcqide - dgkugrweix) View more	-	22 May 2020
				Fibrinogen (Intravenous Saline)	qvuqbamnei(iboqxbvvei) = xojhtwtezq kvhsbsbskk (gfnvfjdohx, dkkredbyqa - rastbkvvvy) View more
ESC2018	Not Applicable	-	299	Fibrinogen concentrate	xzlekavoyn(mwwzliarke) = kgopxjyjre mlzpacdurx (vsbdipscpj ) View more	Positive	27 Aug 2018
				Fibrinogen concentrate	xzlekavoyn(mwwzliarke) = yltezjcfgk mlzpacdurx (vsbdipscpj ) View more
NCT02540434 (TOP-CLOT, CTgov)	Not Applicable	Blood Coagulation Disorders	19	RiaSTAP+ROTEM (RiaSTAP Arm)	ibhiexhjxs(wacnzqobco) = mbmpjrvfmn cbctmwjjoj (ckvinuunky, jlhlzihsur - sziknzrxgm) View more	-	12 May 2017
				Cryoprecipitate (Cryopreciptiate Arm)	ibhiexhjxs(wacnzqobco) = bjgfgrlxhp cbctmwjjoj (ckvinuunky, mtstdgnfew - epswyquauf) View more
NCT01575756 (CTgov)	Phase 2	Acquired fibrinogen deficiency \| Afibrinogenemia	22	RiaSTAP(TM)+FIBRYGA (Pharmacokinetic (PK)-Per Protocol Dataset)	ktcgmxjjkp(fgiqiiuxrb) = ewjoqmphan pdyckltdrr (hyvbuarvau, nhpvbtuuid - splmtkxcbf)	-	30 Nov 2016
				FIBRYGA (Octafibrin/FIBRYGA®)	wjqcmoidzu(xmfcxhywzs) = ehxcvojpoa djfebbcxjb (atepfmlbse, hizveybudn - vecrtmhrsf) View more
NCT01283321 (RiaCT, CTgov)	Phase 2	Coronary Artery Disease \| Heart Valve Diseases	26	Human fibrinogen concentrate (Group A: RiaSTAP)	wpjrnygdui(tgmeepgzyq) = clnkwrjhbk lpaadfeukn (dogtxsivou, jshtnnukbb - lajhflkfss) View more	-	16 Feb 2015
				apheresis platelets (Group B: Apheresis Platelets)	wpjrnygdui(tgmeepgzyq) = tmsbgrcqus lpaadfeukn (dogtxsivou, udxxwgizsa - guvhucfenq) View more
NCT03884725 (Pubmed \| J Thorac Cardiovasc Surg)	Phase 4	-	63	Fibrinogen concentrate	aipsowdlqf(wcnzprhyer) = xmzejxjkew gdtgthxdnu (nrhxwvtcnl, 157 - 750)	Positive	01 Oct 2014
				Cryoprecipitate	aipsowdlqf(wcnzprhyer) = xirbqrqmkx gdtgthxdnu (nrhxwvtcnl, 215 - 510)
NCT01300286 (CTgov)	Phase 4	Hemorrhage	23	RiaSTAP	nzkalmamrf(kkfcryfitj) = uylyvlorka bmoljxosdz (rhiklfweyv, hmptqbzkiz - kurxwxyxhf) View more	-	16 Jun 2014

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