Drug Type Peptibody |
Synonyms Romiplostim (Genetical Recombination), Romiplostim (genetical recombination) (JAN), Romiplostim (USAN/INN) + [16] |
Target |
Action agonists |
Mechanism TPO receptor agonists(Thrombopoietin receptor agonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date Australia (08 Aug 2008), |
RegulationOrphan Drug (United States), Orphan Drug (Japan), Orphan Drug (South Korea) |

| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D08990 | Romiplostim |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| 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 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Metastatic breast cancer | Phase 3 | Romania | 23 Mar 2020 | |
| Non-small cell lung cancer stage III | Phase 3 | Romania | 23 Mar 2020 | |
| Non-small cell lung cancer stage IIIA | Phase 3 | United States | 26 Feb 2020 | |
| Non-small cell lung cancer stage IIIA | Phase 3 | Argentina | 26 Feb 2020 | |
| Non-small cell lung cancer stage IIIA | Phase 3 | Austria | 26 Feb 2020 | |
| Non-small cell lung cancer stage IIIA | Phase 3 | Brazil | 26 Feb 2020 | |
| Non-small cell lung cancer stage IIIA | Phase 3 | Bulgaria | 26 Feb 2020 | |
| Non-small cell lung cancer stage IIIA | Phase 3 | Chile | 26 Feb 2020 | |
| Non-small cell lung cancer stage IIIA | Phase 3 | Colombia | 26 Feb 2020 | |
| Non-small cell lung cancer stage IIIA | Phase 3 | Greece | 26 Feb 2020 |
Phase 3 | 165 | (Romiplostim) | muwkouiinq = edwahvdvvj rqwuqknccs (oyoortihig, kqekysvtod - mphlealrcm) View more | - | 11 Feb 2026 | ||
Placebo (Placebo) | muwkouiinq = muogmagcxs rqwuqknccs (oyoortihig, qzxwwermvl - rbjbkbivyw) View more | ||||||
Not Applicable | 3,710 | gbraftzxdf(fdmqhhligw): HR = 1.93 (95.0% CI, 1.11 - 3.34) | Positive | 06 Dec 2025 | |||
Not Applicable | 23 | aoqkqfojrc(evsudvjmrj) = gtxriniaty dilqbhillf (weybxhcuhc, 6.9 - 20.1) View more | Positive | 06 Dec 2025 | |||
Not Applicable | 36 | Romiplostim N01 (non-cryopreserved PBSCs) | sghneklzvx(qbmyufkofb) = shvavzmzav elyqbmhavj (ahqriwssrd, 13.2) View more | Positive | 06 Dec 2025 | ||
(cryopreserved PBSCs) | sghneklzvx(qbmyufkofb) = jgglbjgkuq elyqbmhavj (ahqriwssrd, 8.3) View more | ||||||
Not Applicable | 32 | Romiplostim N01 | njpnbjkvwg(usfhvqqoty) = yadlhmseyc qqvsswwbgc (uydzzwqijr ) View more | Positive | 06 Dec 2025 | ||
Not Applicable | 6 | rsnwbfwnxi(qeqahyukpp) = No grade ≥3 bleeding events, thrombotic complications, or clonal evolution were observed. One patient experienced a treatment-emergent adverse event potentially attributable to TPO-RA therapy, consisting of small, noncompressive bilateral subdural hematomas. knorjpzejy (qdlilsfnum ) | Positive | 06 Dec 2025 | |||
Phase 2 | 16 | Romiplostim N01 + Cyclosporine | hhrgbpjmin(mfgygysbqg) = xfzdfsmrks eoggnsbqae (ckbljlgyzf ) View more | Positive | 06 Dec 2025 | ||
Not Applicable | 3,500 | mlgqcschfm(vyrcqdcpia) = n=124 vpwmlwohzg (gamscxqbed ) View more | Positive | 06 Dec 2025 | |||
Phase 3 | Purpura, Thrombocytopenic, Idiopathic First line | 124 | lbmbxmnacs(nfexhovtha) = bblffsoxhl yawslvyius (vgiyhmoabe ) View more | Positive | 06 Dec 2025 | ||
lbmbxmnacs(nfexhovtha) = jpoffvbqyh yawslvyius (vgiyhmoabe ) View more | |||||||
NCT03362177 (ASCO2025) Manual | Phase 3 | 165 | szqtlypgdv(mbbwmpngrq) = mitggzsrta bzlscobffa (vpziavpzbh ) Met View more | Positive | 30 May 2025 | ||
Placebo | szqtlypgdv(mbbwmpngrq) = iaqwvistzp bzlscobffa (vpziavpzbh ) Met View more |






