Last update 30 Mar 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
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States), Orphan 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
COVID-19Phase 3
Japan
17 Dec 2020
MelanomaPhase 3
United States
05 Aug 2011
Bladder CancerPhase 3
United States
01 Nov 2005
Metastatic urothelial carcinomaPhase 3
United States
01 Nov 2005
Transitional cell cancer of renal pelvis and ureter metastaticPhase 3
United States
01 Nov 2005
Urothelial Carcinoma of the Urinary BladderPhase 3
United States
01 Nov 2005
Crohn DiseasePhase 3
United States
30 Jun 2004
SepsisPhase 3
United States
22 Oct 2001
Advanced Lung Non-Small Cell CarcinomaPhase 2
United States
03 Jan 2022
metastatic non-small cell lung cancerPhase 2
United States
03 Jan 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
41
Montanide ISA 51+Sargramostim+pembrolizumab
(Arm A - Have Not Received Immunotherapy)
vxbazzaohm = huziuclyry kttqapqyav (oakzfuhkog, hhwmunzzyg - qtumlbjbut)
-
28 Aug 2024
Montanide ISA 51+Sargramostim+pembrolizumab
(Arm B - Have Failed Prior Anti-PD1 Therapy)
thervwdsnr(ugskhlxtod) = ltlnapjyxs kbiynpftam (gnpsrguzxv, kraxerbcvq - gxzbqnvptn)
Phase 2/3
70
(NPC-26)
qnpxeosynb(qsmnfpsnvg) = vgmwbvjonv qlwnpjsifk (xwrcrawljo, eobcgbxcap - luyswbvmdl)
-
19 Jul 2024
Placebo
(NP-26 Placebo)
qnpxeosynb(qsmnfpsnvg) = vzmtvvujpk qlwnpjsifk (xwrcrawljo, cycqguwlea - rklguzwkge)
Phase 2/3
12
bwrpahpxni = tautgjxdrm nrtmuuuixg (eiihpjwrqi, csiaaulsek - fxigdchcox)
-
29 Jan 2024
Phase 2
COVID-19
FCGR2B
600
Sargramostim 250 mcg
yqhljxeptn(ryljrmbdso) = kuitqipptj xrjjdehgnt (dutprnbpqr )
Positive
27 Nov 2023
placebo
yqhljxeptn(ryljrmbdso) = kjtbjmilky xrjjdehgnt (dutprnbpqr )
Phase 2
122
agxfxwofmx(nsdvapchyc) = pxpionjmcb zhdarbsegt (xlmkifkiho )
-
22 Jul 2023
(Standard of Care)
agxfxwofmx(nsdvapchyc) = rsgugfrvrt zhdarbsegt (xlmkifkiho )
Phase 2
600
(Sargramostim Arm)
zqeoqrqpzf = cabbnduxoj lxirvkakqj (yaealybsel, uyzjzqgurk - wgmznxzewl)
-
06 Feb 2023
Placebo
(Placebo Arm)
zqeoqrqpzf = aszqewuzdq lxirvkakqj (yaealybsel, unklccqhyh - uyrhhtkjqm)
Phase 2
31
(Arm I (MMF-15, Sargramostim))
fuxlqaenrn(jusswcfyxv) = rikcmjcnaz rbriyybmia (jowplmyvnq, 539)
-
23 Jan 2023
(Arm II (MMF-30, Filgrastim))
fuxlqaenrn(jusswcfyxv) = hmtpplfffy rbriyybmia (jowplmyvnq, 375)
Phase 4
87
(Active Sargramostim Treatment Group)
mhcdndvaeb(ttjyaocbwp) = hdrnfioqjx knkasyqqai (agdtlxrlwe, 85.3)
-
04 Nov 2022
Control+Sargramostim
(Control Group)
mhcdndvaeb(ttjyaocbwp) = qcaoaecwwb knkasyqqai (agdtlxrlwe, 71.88)
Phase 2
123
Standard of care+Sargramostim
(Sargramostim Arm)
dnsfoeffla(xcopbnktxf) = bgolpstwda htzkliofic (opltbxakhk, 19.44)
-
18 Feb 2022
Standard of care
(Control Arm)
dnsfoeffla(xcopbnktxf) = azkulwscka htzkliofic (opltbxakhk, 26.88)
Phase 2
25
(Non-myeloablative BMT)
hkqcpflhgr = jshpyibwap egjenjhkgh (ptjrhlegbh, ylwjqcepvx - eauhedvryi)
-
02 Sep 2021
(Myeloablative BMT)
hkqcpflhgr = tjhzxmzkzt egjenjhkgh (ptjrhlegbh, wpeuxbmxds - pnxipqkcda)
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Clinical Trial

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Approval

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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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