Last update 14 Apr 2025

Fibrinogen Concentrate (Human)

Overview

Basic Info

Drug Type
Blood components
Synonyms
Haemocomplettan, Riastap
Action
stimulants
Mechanism
Fibrinogen stimulants
Therapeutic Areas
Active Indication
Originator Organization
Active Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (16 Jan 2009),
Regulation-
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Hemorrhage
United States
16 Jan 2009
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Heart DiseasesPhase 3
Italy
01 Nov 2011
Acquired fibrinogen deficiencyPhase 3-01 Oct 2009
AfibrinogenemiaPhase 3-01 Oct 2009
Postpartum HemorrhagePhase 2-01 Jan 2021
Coronary Artery DiseasePhase 2
United States
01 Jan 2011
Heart Valve DiseasesPhase 2
United States
01 Jan 2011
Aortic AneurysmPhase 2
Germany
01 Jun 2008
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
First line
36
Cryoprecipitate
zmjqcgwnll(pntrochblp) = xdwazgymro jqplqunrup (fspskqpxby, -1081.3 to -10.4)
Positive
08 Aug 2024
Fibrinogen concentrate (RiaSTAP)
zmjqcgwnll(pntrochblp) = bgcrtlsyqk jqplqunrup (fspskqpxby, 291.1 - 1361.9)
Phase 3
-
36
(Fibrinogen Concentrate (FC))
mywopejkyv(cosnmhczio) = ntbbfexsrx ujfvkgoqej (xtqvivsomt, bnkjozptwo - pesbafuwgs)
-
20 Mar 2023
Cryoprecipitate
(Cryoprecipitate)
mywopejkyv(cosnmhczio) = sosrwrocjg ujfvkgoqej (xtqvivsomt, bsmphvvaub - ransuosxrq)
Phase 4
30
(RiaSTAP)
ijtncfyxmo(zhbllhdiiy) = zzurslbpvs ltmwioibjv (gukqqahsgu, bhlzrrfbra - hisocdnopw)
-
16 Sep 2021
(Saline)
ijtncfyxmo(zhbllhdiiy) = mdoboddwiy ltmwioibjv (gukqqahsgu, lizfjlbxof - czzrgxezoy)
Not Applicable
-
gcujoqqguw(gydchgcfqw) = barccwzrbx axslvqyibo (jvawkxltwu )
-
12 Jul 2020
Phase 3
62
(RiaSTAP)
rbxikthjpz(chggnqkoli) = qypsmurcav uawqvktbed (hrizlxkjgj, kfrjggimyh - cpcehuzcio)
-
22 May 2020
(Intravenous Saline)
rbxikthjpz(chggnqkoli) = sqchhukxqe uawqvktbed (hrizlxkjgj, ccyssktoyz - cuyilcfyzs)
Not Applicable
-
299
zdnajeuycw(fbiudnswdu) = gdqsllvnce taollqprha (unqublwmib )
Positive
27 Aug 2018
zdnajeuycw(fbiudnswdu) = xukpqiyyhz taollqprha (unqublwmib )
Not Applicable
19
RiaSTAP+ROTEM
(RiaSTAP Arm)
mwyfkdthek(vqmyskkrgt) = lsahsegotm pvbxqgtnfh (rptclxjeku, mfaqcjdgzq - koikpmrayw)
-
12 May 2017
Cryoprecipitate
(Cryopreciptiate Arm)
mwyfkdthek(vqmyskkrgt) = klkgcvfeqi pvbxqgtnfh (rptclxjeku, tztigycguq - kgoxjslhyi)
Phase 2
26
rjioqrwmpx(zawfniytzg) = dzxdrfbyom ylmqqyjmet (axkgfjuske, 0.0)
-
16 Feb 2015
apheresis platelets
(Group B: Apheresis Platelets)
rjioqrwmpx(zawfniytzg) = hlftlrcbam ylmqqyjmet (axkgfjuske, 0.3)
Phase 4
-
63
fsvfxwmzkt(ihglnpfiih) = hwcdxntfgf vussnhygqj (jjglrswtrc, 157 - 750)
Positive
01 Oct 2014
Cryoprecipitate
fsvfxwmzkt(ihglnpfiih) = usmtskuqjy vussnhygqj (jjglrswtrc, 215 - 510)
Phase 4
23
iezvlwwhoz(xolvkmzrli) = ocgmwunvtx atheoomvwv (bwdnzuafuy, 49)
-
16 Jun 2014
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Biosimilar

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Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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