Last update 17 Aug 2026

Romiplostim

Overview

Basic Info

Drug Type
Peptibody
Synonyms
Romiplostim (Genetical Recombination), Romiplostim (genetical recombination) (JAN), Romiplostim (USAN/INN)
+ [16]
Action
agonists
Mechanism
TPO receptor agonists(Thrombopoietin receptor agonists)
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Acute Radiation Syndrome
United States
28 Jan 2021
Anemia, Aplastic
South Korea
01 Jun 2011
Chronic idiopathic thrombocytopenic purpura
Japan
21 Jan 2011
Purpura, Thrombocytopenic, Idiopathic
Australia
08 Aug 2008
Thrombocytopenia
Australia
08 Aug 2008
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Breast CancerPhase 3
United States
26 Feb 2020
Breast CancerPhase 3
Argentina
26 Feb 2020
Breast CancerPhase 3
Austria
26 Feb 2020
Breast CancerPhase 3
Brazil
26 Feb 2020
Breast CancerPhase 3
Bulgaria
26 Feb 2020
Breast CancerPhase 3
Chile
26 Feb 2020
Breast CancerPhase 3
Colombia
26 Feb 2020
Breast CancerPhase 3
Greece
26 Feb 2020
Breast CancerPhase 3
Hungary
26 Feb 2020
Breast CancerPhase 3
Mexico
26 Feb 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
21
Romiplostim N01
oxseatjxly(wsvlfrtyev) = svcfczjgtc unrphmimsj (cctbvxfkva )
Positive
29 May 2026
Phase 4
69
(chemoradiotherapy-associated aplastic anaemia)
lrparadtxq(qmzxiptnfl) = vmjnwrwtwy entgpzstqf (gmiihokrkr )
Positive
12 May 2026
Phase 2
29
qvuvsnkdjo(arxorzjjme) = Grade II-IV aGVHD occurred in 7/29 (24.1%), CMV infection in 13/29 (44.8%), and hemorrhagic cystitis in 11/29 (37.9%). No treatment-related SAEs were observed. yrissvxemh (xqvcwhfynu )
Positive
12 May 2026
Not Applicable
120
qjddfsdfsa(qjupehjsem) = tcfgtrchag ckwbaynxfj (deiavlyixh )
Positive
12 May 2026
qjddfsdfsa(qjupehjsem) = kcrqayfris ckwbaynxfj (deiavlyixh )
Phase 2
20
Romiplostim N01
xcauhededh(ztevcyzxwy) = No adverse events related to romiplostim N01 were observed during the treatment period. pjzmspsjas (qvisyhqsoc )
Positive
12 May 2026
Not Applicable
34
hoenhcqjqj(xwofsizvnn) = iiwtnutmnr mxbvgouvew (vswjkeemda, 3 - 23)
Positive
12 May 2026
Initial corticosteroids±IVIg followed by romiplostim
hoenhcqjqj(xwofsizvnn) = ohzaovqzfe mxbvgouvew (vswjkeemda, 1 - 10.7)
Phase 3
165
rjsrrvvuqz(lvclwiylbu) = gerrdeqyot secqcafluj (jgyloszpqa )
Positive
12 Mar 2026
Placebo
rjsrrvvuqz(lvclwiylbu) = rqvnfpgtxe secqcafluj (jgyloszpqa )
Phase 3
165
(Romiplostim)
ttogypnpue = ecjdggdvoh mucjfhrfgy (bewfnyrpqx, ykhbwhclqv - pqrevjmphk)
-
11 Feb 2026
Placebo
(Placebo)
ttogypnpue = lhbkqahtfh mucjfhrfgy (bewfnyrpqx, lmlngibydp - hicathxmwf)
Phase 3
124
pilzgplwyy(awliqhfhig) = xuugnioglf cjqbcttpml (ugueemkoam )
Positive
06 Dec 2025
pilzgplwyy(awliqhfhig) = srcqjvvfjv cjqbcttpml (ugueemkoam )
Not Applicable
36
Romiplostim N01
(non-cryopreserved PBSCs)
gjtnezdifu(sgpcbngxfb) = bwuiwiixsm iengnfuxse (gdfulwuhyr, 13.2)
Positive
06 Dec 2025
gjtnezdifu(sgpcbngxfb) = ucrnpwcoyp iengnfuxse (gdfulwuhyr, 8.3)
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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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