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 recruitingNot Applicable

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-

NCT05449834

/ RecruitingPhase 3IIT

Fibrinogen Early In Severe Trauma StudY II

Annually over 7000 Australians are treated for severe trauma. Haemorrhage secondary to severe trauma is a major cause of potentially preventable death and poor outcomes in Australian adults. Severe trauma may trigger changes in blood clotting mechanisms and factor levels leading to inhibition of clot formation and reduced clot strength. This results in the inability of the severely injured trauma patient to form adequate clots to help stop bleeding. There is good evidence to suggest the loss of clotting factors during haemorrhage is associated with worse outcomes and it is thought the early replacement of these factors may reduce bleeding and improve patient outcomes. Fibrinogen is a key clotting factor that helps bind clots together and early fibrinogen replacement may improve outcomes.
Currently fibrinogen is replaced using cryoprecipitate, a blood product made from blood donated by healthy donors which is a precious resource. It can take a significant amount of time to administer as it is frozen and stored in the blood bank. Timely administration of cryoprecipitate is difficult as it requires thawing prior to transfusion. The large doses of cryoprecipitate used in traumatic haemorrhage can put strain on local blood banks in supplying requested units in a timely manner. Additionally, the widely dispersed population of Australia introduces logistic challenges to the maintenance of adequate cryoprecipitate stocks to individual hospital blood banks, especially in remote regions. However, cryoprecipitate contains a number of other coagulation factors (not just fibrinogen) that may be instrumental in clot formation and resistance to fibrinolysis.
Fibrinogen concentrate is an alternative product used to assist in blood clotting. It is a dry powder form of fibrinogen and can be reconstituted at the bedside and given quickly. The use of a fibrinogen factor concentrate with a long shelf life that is easy to use has significant implications for both large urban metropolitan areas and remote isolated communities.
The timing and mode of fibrinogen replacement in traumatic haemorrhage has implications for patient outcomes, blood product availability, costs and the national blood supply. Despite the importance of fibrinogen replacement in traumatic haemorrhage, there have been no clinical trials powered for clinical outcomes directly comparing fibrinogen concentrate and cryoprecipitate. FEISTY II will evaluate the efficacy, safety and cost-effectiveness of Fibrinogen Concentrate vs Cryoprecipitate in trauma patients with major haemorrhage.
FEISTY II is a phase III randomised trial which will enrol 850 patients from Australian and New Zealand major trauma centres, with a primary patient outcome of days alive out of hospital at day 90 after injury. Severely injured trauma patients who require blood transfusion and have evidence of low fibrinogen levels will be randomised to receive either fibrinogen concentrate or standard care with cryoprecipitate

Start Date21 Nov 2022

Sponsor / Collaborator

Australian and New Zealand Intensive Care Research Centre

[+2]

100 Clinical Results associated with Fibrinogen Concentrate (Human)

100 Translational Medicine associated with Fibrinogen Concentrate (Human)

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

544

Literatures (Medical) associated with Fibrinogen Concentrate (Human)

01 May 2026·INTERNATIONAL JOURNAL OF OBSTETRIC ANESTHESIA

Hyperfibrinolysis and reduced functional fibrinogen in haemorrhagic caesarean delivery: a secondary analysis of the TRACES trial evaluating fibrinogen kinetics following fibrinogen concentrate or plasma infusion

Article

Author: Bouthors, Anne-Sophie ; Abraham, Emilien ; Ollier, Edouard ; Lanoiselée, Julien ; Denys, Bérangère ; Hureau, Maxence

INTRODUCTION:

Postpartum haemorrhage-induced coagulopathy is marked by early fibrinogen depletion and, in acute obstetric coagulopathy, by hyperfibrinolysis and fibrinogenolysis. It remains unclear that exogenous fibrinogen concentrate is similarly susceptible to plasmin-mediated degradation. This secondary analysis of the TRACES trial assessed fibrinogen restoration kinetics after fibrinogen concentrate administration during postpartum hemorrhage.

METHODS:

The TRACES trial was a multicentre, randomised, double-blind, placebo-controlled study investigating tranexamic acid dosing in haemorrhagic caesarean delivery. For this analysis, only patients receiving fibrinogen concentrate were included. All laboratory and clinical data were re-timestamped relative to the first fibrinogen concentrate administration. Hyperfibrinolysis (HF) was defined by fibrinogen < 300 mg/dL, D-dimer ≥ 50,000 ng/mL and plasmin-antiplasmin complexes ≥ 2,000 ng/mL at any time point. Fibrinogen restoration trajectories were compared between cases with HF and No HF.

RESULTS:

Among 151 patients, 34 received fibrinogen concentrate. Five met HF criteria. Despite receiving higher fibrinogen concentrate doses, HF patients showed significantly impaired fibrinogen restoration (p < 0.01), with an initial rise followed by early decline. HF status was also associated with increased blood loss during postpartum hemorrhage.

DISCUSSION:

These exploratory findings support the hypothesis that exogenous fibrinogen may undergo plasmin-mediated cleavage in acute obstetric coagulopathy, leading to restoration failure and highlight the hypothesis of fibrinogenolysis.

CONCLUSION:

Hyperfibrinolysis markedly impairs fibrinogen concentrate-mediated fibrinogen restoration during postpartum haemorrhage. Dedicated pharmacokinetic-pharmacodynamic studies are needed to optimise fibrinogen supplementation and hemostatic strategies.

01 Mar 2026·THROMBOSIS RESEARCH

Efficacy and safety of prophylaxis and treatment of bleeding events with a novel fibrinogen concentrate from human plasma in patients with congenital fibrinogen deficiency

Article

Author: Schuettrumpf, Joerg ; Abraha, Salomon ; Khayat, Claudia Djambas ; Belhadjali, Emna Gouider ; Miesbach, Wolfgang ; Adolf, Sonia ; Khelif, Abderrahim ; Omar, Naglaa ; El-Beshlawy, Amal ; Boehm, Heike ; Aigner, Silke

BACKGROUND:

Congenital fibrinogen deficiency is a rare inherited coagulation disorder characterized by partial or total lack of plasma fibrinogen (hypo- or afibrinogenemia), or expression of dysfunctional fibrinogen (dysfibrinogenemia), which may cause plasma level reduction (hypodysfibrinogenemia). Loss of functional fibrinogen causes bleeding disposition. In case of trauma or surgical intervention, supplementation of human fibrinogen is required to stop or prevent extensive bleeding events.

STUDY DESIGN:

A prospective, open-label, uncontrolled, multi-center phase I/III trial was performed to investigate pharmacokinetics, efficacy and safety of single and/or repetitive intravenous infusions of a human fibrinogen concentrate (BT524) for on-demand prophylaxis (ODP) and/or on-demand treatment (ODT) of bleeding events in patients with congenital fibrinogen deficiency.

PATIENTS:

In the phase III part of the trial reported here, 36 patients (3 children <6 years, 9 children 6-12 years, 4 adolescents and 20 adults) were treated with BT524 for 175 bleeding events, either for ODP or ODT.

RESULTS:

Fibrinogen concentrate infusion substantially improved maximum clot firmness (MCF). The overall hemostatic response was rated as good or excellent in 98.9% of bleedings. Loss of blood was considered normal in the majority of surgical interventions, and wound healing was also positively assessed. Additional evaluations, including blood product consumption and adverse events, further supported the efficacy and confirmed the favorable safety profile of the novel fibrinogen product.

CONCLUSION:

BT524 represents a novel human fibrinogen concentrate provenly efficacious and safe both for the treatment of bleeding and for peri-operative bleeding prophylaxis in patients with congenital fibrinogen deficiency of all ages.

04 Feb 2026·AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE

Severe Red-Necked Keel-Back Snake (Rhabdophis subminiatus) Envenomation in Two Cases and a Literature Review

Review

Author: Lai, Rong de ; Pan, Wei Yuan ; Wu, Jing Yi ; Lu, Pan Pan

ABSTRACT.:

In the present article, two cases of envenomation by Rhabdophis subminiatus are reported, including a detailed analysis of the toxicological mechanisms, clinical manifestations, and therapeutic management, along with a systematic review of globally reported cases of Rhabdophis subminiatus envenomation. Both patients (both male, aged 58 years and 55 years, respectively) sought medical treatment several days after being bitten on the hand and developed life-threatening consumptive coagulopathy and hemorrhagic diathesis. The 58-year-old patient (Case 1) presented with local swelling, pain, abdominal hematoma, and shortness of breath. After treatment with antivenom, transfusion of packed red blood cells, fresh-frozen plasma, cryoprecipitate, and mechanical ventilation, his coagulation function returned to nearly normal levels. He was discharged 15 days after admission to the study hospital. The 55-year-old patient (Case 2) presented with oral bleeding and swelling distal to the bite site. After treatment with antivenom and transfusion of fibrinogen concentrate, packed red blood cells, and fresh-frozen plasma, his coagulation function returned to normal. He was discharged 11 days after admission to the study hospital. A literature review revealed more than 50 reported cases worldwide, all of which highlighted hemorrhagic syndrome and profound coagulopathy as hallmark features. Most cases were managed symptomatically, with only a minority receiving antivenom. Although the overall prognosis was generally favorable, the case fatality rate reached 12.7%. Envenomation by Rhabdophis subminiatus constitutes a significant medical emergency that requires early intervention with polyvalent antivenom (such as anti- Agkistrodon / Deinagkistrodon antivenom) combined with targeted supportive therapy to optimize clinical outcomes.

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
Heart Diseases	Phase 3	Italy	CSL Behring LLC	01 Nov 2011
Afibrinogenemia	Phase 3	-	CSL Behring LLC	01 Oct 2009
Postpartum Hemorrhage	Phase 2	United Kingdom	CSL Behring GmbH	07 May 2013
Coronary Artery Disease	Phase 2	United States	CSL Behring LLC	01 Jan 2011
Heart Valve Diseases	Phase 2	United States	CSL Behring LLC	01 Jan 2011
Aortic Aneurysm	Phase 2	Germany	CSL Behring LLC	01 Jun 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05780125 (Pubmed \| Anesth Analg)	Phase 2	-	-	FibCLOT	ssydroybnu(eyhqkwpant) = xwehpfprof eaqkngudvc (bvhxlkpxcc, 1.2)	Negative	01 Apr 2025
				RiaSTAP	ssydroybnu(eyhqkwpant) = kdgkqcdjwp eaqkngudvc (bvhxlkpxcc, 1.6)
NCT03932240 (CTgov)	Phase 3	-	36	Fibrinogen Concentrate (FC) (Fibrinogen Concentrate (FC))	oexxbogrja(iztuvnlqus) = ptmhhgepcf eqhvesqvln (knnzdazvav, hpcscwqhqi - hrhyydnpdw) View more	-	20 Mar 2023
				Cryoprecipitate (Cryoprecipitate)	oexxbogrja(iztuvnlqus) = ordxapuvpo eqhvesqvln (knnzdazvav, lfzmflaxcy - lcrpqfprjq) View more
NCT02822599 (RiaSTAP, CTgov)	Phase 4	Hemorrhage \| Afibrinogenemia	30	RiaStAP (RiaSTAP)	jbscctcvmk(vwtverhgev) = fhonugdlzx ajxbrgtljj (ipnfygfitw, bfpfmbchrn - zzlebhxqww) View more	-	16 Sep 2021
				Saline (Saline)	jbscctcvmk(vwtverhgev) = vvbphpzbmf ajxbrgtljj (ipnfygfitw, vlxlfwsnbd - ahrhnexltp) View more
NCT01623531 (CTgov)	Phase 3	Intraoperative Complications	62	Fibrinogen (RiaSTAP)	mpfiqoouee(zufmrdomup) = lfzzvilead gkuxmcrfbc (bbwzogahce, grkznnuvys - pblqaprymk) View more	-	22 May 2020
				Fibrinogen (Intravenous Saline)	mpfiqoouee(zufmrdomup) = plfrxboruo gkuxmcrfbc (bbwzogahce, nombqflrfd - nlltdyqspk) View more
NCT01623531 (Pubmed \| Acta Anaesthesiol Scand)	Not Applicable	-	62	Fibrinogen concentrate	wflmsuebdg(yuppofyxbq) = mxnbcokyjk uohkmyhiee (idpgxcnirl )	-	01 May 2020
				Placebo	wflmsuebdg(yuppofyxbq) = znujilzokp uohkmyhiee (idpgxcnirl )
NCT02540434 (TOP-CLOT, CTgov)	Not Applicable	Blood Coagulation Disorders	19	RiaSTAP+ROTEM (RiaSTAP Arm)	zgmrtfoxon(dnxzezjrrz) = dwaqwunwec gcaergaeoj (dosrmeenjg, icfnginvzq - xhbojoftct) View more	-	12 May 2017
				Cryoprecipitate (Cryopreciptiate Arm)	zgmrtfoxon(dnxzezjrrz) = qefhnehfpu gcaergaeoj (dosrmeenjg, nbrhigeyyg - xydkspumbw) View more
EUCTR2009-018086-12-NL \| NCT01124981 (Pubmed \| JAMA)	Phase 2/3	Blood Loss, Surgical	120	Fibrinogen concentrate	glyzrjzepi(gtwbuubswm) = tbgsyuizvm kdaipkkvzm (tesbtctwtv )	Negative	21 Feb 2017
				Placebo	glyzrjzepi(gtwbuubswm) = sinaubyouy kdaipkkvzm (tesbtctwtv )
NCT01471730 (Pubmed \| J Am Heart Assoc)	Phase 3	First line	119	Fibrinogen concentrate	icrgqpxqyo(igpjvzrhop) = lkcrxddpwo dyxwsazxig (ioneiviuxz )	Positive	02 Jun 2015
				Saline solution	icrgqpxqyo(igpjvzrhop) = qfoqzsxhgz dyxwsazxig (ioneiviuxz )
NCT01283321 (RiaCT, CTgov)	Phase 2	Coronary Artery Disease \| Heart Valve Diseases	26	Human fibrinogen concentrate (Group A: RiaSTAP)	zlbgclaxtf(mqcgwmzaqn) = ihhkgazthk userphcwsv (cmvmbexxkn, 0.0) View more	-	16 Feb 2015
				apheresis platelets (Group B: Apheresis Platelets)	zlbgclaxtf(mqcgwmzaqn) = lbyzamsuej userphcwsv (cmvmbexxkn, 0.3) View more
NCT01300286 (CTgov)	Phase 4	Hemorrhage	23	RiaSTAP	wsskmkytze(qdayvwkzhj) = avmtvlkerc gkvysuwbxh (dxywbfcrir, 49) View more	-	16 Jun 2014

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