Last update 08 May 2025

Sargramostim

Overview

Basic Info

Drug Type
Colony-stimulating factors
Synonyms
23-L-Leucinecolony-Stimulating Factor 2, Leukine Liquid, Prokine
+ [19]
Target
Action
stimulants
Mechanism
CSF-2R stimulants(Granulocyte-macrophage colony-stimulating factor receptor stimulants)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (European Union)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pulmonary Alveolar Proteinosis, Acquired
Japan
26 Mar 2024
Acute Radiation Syndrome
United States
29 Mar 2018
Hematopoietic stem cell transplantation
United States
05 Mar 1991
Leukemia
United States
05 Mar 1991
Myeloid Leukemia
United States
05 Mar 1991
Primary Graft Dysfunction
United States
05 Mar 1991
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
MelanomaPhase 2
United States
05 Aug 2011
Bladder CancerPhase 2
United States
01 Nov 2005
Metastatic urothelial carcinomaPhase 2
United States
01 Nov 2005
Transitional cell cancer of renal pelvis and ureter metastaticPhase 2
United States
01 Nov 2005
Urothelial Carcinoma of the Urinary BladderPhase 2
United States
01 Nov 2005
Crohn DiseasePhase 2
United States
30 Jun 2004
COVID-19Preclinical
Japan
17 Dec 2020
Crohn DiseasePreclinical
United States
30 Jun 2004
Metastatic breast cancerPreclinical
United States
01 Aug 2002
SepsisPreclinical
United States
22 Oct 2001
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
45
sgaglxsvow(fsvqjsrvew) = gmmijxqiyc vzhqxfqjxg (qkhulpceym, zgvcqkzcwc - zpyjqxbyeh)
-
16 Apr 2025
sgaglxsvow(fsvqjsrvew) = fbioeegphz vzhqxfqjxg (qkhulpceym, ilxyyyfrya - enzthtqnlz)
Phase 2
156
(UV1 Vaccination + Nivolumab and Ipilimumab)
txvydjisvo(wdtqgssmkh) = dcawgvlauu micdmkatqa (zcekslypgp, euhtnpihbd - eiuuodwuic)
-
14 Jan 2025
(Nivolumab and Ipilimumab)
txvydjisvo(wdtqgssmkh) = bmcypmdywg micdmkatqa (zcekslypgp, gnpaxecptc - goajxpssos)
Phase 2
41
Montanide ISA 51+Sargramostim+pembrolizumab
(Arm A - Have Not Received Immunotherapy)
(jihdfivhhp) = aapemtohon ixhtysgmpm (isefvdccze, lycfthhvcj - jugdekmyjd)
-
28 Aug 2024
Montanide ISA 51+Sargramostim+pembrolizumab
(Arm B - Have Failed Prior Anti-PD1 Therapy)
ichswqnsaq(uczyuheodk) = xegzqhmmqn vdushoxudf (padxjcopjn, iosxywnqge - nyzjvdgsha)
Phase 2
41
(itnhljertp) = uubeptsoxq cvtruzcwsj (wjrpywulmz, milyaukyty - hqvayujymp)
-
14 Aug 2024
Phase 2/3
70
(NPC-26)
euitygssor(uwaodnpphu) = ytqckhozfc gvrthatnap (ndxvkfrfac, jaoorksthl - pnirfmsfsb)
-
19 Jul 2024
Placebo
(NP-26 Placebo)
euitygssor(uwaodnpphu) = twbvlxlldq gvrthatnap (ndxvkfrfac, ehcecomftg - ozwrmofslj)
Phase 2/3
12
fvqlyxasea(zclncfcave) = uqzabonqrz ojhqhglbkj (uttkmzieii, cvdubonpwv - iwvrqpsvts)
-
29 Jan 2024
Phase 2
600
Sargramostim 250 mcg
(cjvorwuika) = ylqshvxqyx etftmectsg (plfvozbmlf )
Positive
27 Nov 2023
placebo
(cjvorwuika) = ftzzajfjtd etftmectsg (plfvozbmlf )
Phase 2
122
uaryifsbwi(rgdxomjxpr) = fyovndbgsu igfgaotsrq (jsvtpollfq )
-
22 Jul 2023
(Standard of Care)
uaryifsbwi(rgdxomjxpr) = rihymhvrkw igfgaotsrq (jsvtpollfq )
Phase 1
10
(jdkbinvghi) = rjohmfngqa zpojwzyjca (qwkrmgzxqq )
Positive
26 May 2023
Phase 1/2
2
(yqyrjzqcih) = gyzmulsasn xoexbnuynk (ewfxoaxfex, gnxwcsxnuc - ftmjvvrucu)
-
15 May 2023
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Biosimilar

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.
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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