Last update 04 Nov 2024

Pegfilgrastim (Amgen)

Overview

Basic Info

Drug Type
Colony-stimulating factors
Synonyms
Pegfilgrastim (Genetical Recombination), 培非司亭, KRN-125
+ [10]
Target
Mechanism
CSF-3R agonists(Colony stimulating factor 3 receptor agonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (US)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Stem cell mobilisation
JP
25 Feb 2022
Neutropenia
EU
22 Aug 2002
Neutropenia
IS
22 Aug 2002
Neutropenia
LI
22 Aug 2002
Neutropenia
NO
22 Aug 2002
Febrile Neutropenia
US
31 Jan 2002
Infectious Diseases
US
31 Jan 2002
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Multiple MyelomaPhase 2
JP
01 Sep 2021
Breast CancerPhase 2
US
17 Jan 2013
OstealgiaPhase 2
US
17 Jan 2013
NeoplasmsPhase 2
FR
12 Sep 2008
Bone Marrow NeoplasmsPhase 2
FR
01 Sep 2008
LymphomaPhase 2
FR
01 Sep 2008
Recurrent ovarian cancerPhase 2-01 Oct 2003
Hodgkin's LymphomaPhase 2-01 Apr 2003
Non-Hodgkin LymphomaPhase 2-01 Apr 2003
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
196
larulouvrh(kxasjezdff) = yfogolgjot amfovaibts (moethqvtud )
Positive
25 Jan 2024
larulouvrh(kxasjezdff) = fdyymbvowl amfovaibts (moethqvtud )
Not Applicable
57
zunajdkkzc(uwmpvkrytc) = tbpvylglxu djluzlygsc (jyysflabsp )
-
10 Jun 2022
Phase 2
127
ljlxfsyybx(ovutdjhzkv) = devsdeodvi oymvvkhujm (sxmcaegeko, zdmlawzzap - kboxgmbhlv)
-
06 May 2022
Phase 3
221
hwaauxxvuo(udelyircto) = xsicfcsvos vihwgnfogp (elxdqmzfgp )
Positive
25 Sep 2021
hwaauxxvuo(udelyircto) = shkmlcgfhe vihwgnfogp (elxdqmzfgp )
Phase 3
221
epxgifyqzd(iotmubbuka) = rhfwtioybf owqprlwukc (atvdjiftvg )
-
25 Sep 2021
epxgifyqzd(iotmubbuka) = jxhgmhylmq owqprlwukc (atvdjiftvg )
Phase 2
28
FOLFOXA
ghirifkxjy(bmeeubcacq) = vwauyjxice vdijctisjr (ompvtctgax, qjvqgdgdly - rogkmokjqj)
-
13 Aug 2021
Phase 4
138
(Lupin's Pegfilgrastim)
kecifuhzfd(mpyuxmtuft) = kqdohcefju fascipqjhm (hzckverdry, svcpfrjeku - ysdwhbglhh)
-
15 Jun 2021
(Neulasta®)
kecifuhzfd(mpyuxmtuft) = fjqyzqaadq fascipqjhm (hzckverdry, buslzquiiy - tqgyglzvkr)
Not Applicable
110
xahswjiwsb(glptcwmixx) = ectmgrisgj ojxyobdbin (vieqjtfttj )
Positive
14 Mar 2021
xahswjiwsb(glptcwmixx) = uutlccquds ojxyobdbin (vieqjtfttj )
Not Applicable
57
fkbcbbnmpf(tyleaapwkd) = main side effects were mild fever and bone pain (21.2%) uoesbfzuqi (rpcxmmatnx )
Positive
25 May 2020
Not Applicable
837
(On-body injector)
qehxxlcidx(xzwfiogura): OR = 1.8 (95% CI, 0.9 - 3.6), P-Value = 0.09
Positive
25 May 2020
(Traditional injection)
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Approval

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Regulation

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