Romiplostim N01

Phase 3Protein / enzyme

Romiplostim N01 is one of 162 small molecule programs targeting Cancer Treatment-induced Thrombocytopenia (CTIT). It is currently in Phase 3.

Indications

Total Trials

Active Trials

161

Competitors

Pipeline

Status by Indication[3][1]

Indication

Cancer Treatment-Induced Thrombocytopenia (CTIT)Recruiting

Efficacy and SafetyNot yet recruiting

ThrombocytopeniaNot yet recruiting

Severe Aplastic AnemiaNot yet recruiting

Immune ThrombocytopeniaNot yet recruiting

Hematologic MalignanciesRecruiting

Romiplostim N01Not yet recruiting

Cancer Treatment-Induced Thrombocytopenia (CTIT)Phase 2

Recruiting

Efficacy and SafetyPhase 3

Not yet recruiting

ThrombocytopeniaPhase 2

Not yet recruiting

Severe Aplastic AnemiaPhase 3

Not yet recruiting

Immune ThrombocytopeniaPhase 2

Not yet recruiting

Hematologic MalignanciesPhase 2

Recruiting

Romiplostim N01Phase 3

Not yet recruiting

Competition

Competitive Landscape

242 competitors in Efficacy and Safety

#DrugCompanyPhaseTrials

Kineret

SSwedish Orphan Biovitrum

Phase 3

2 2

Telitacicept

VVor Biopharma

Phase 3

4 3

Ivarmacitinib

FFudan University

Phase 3

2 4

Romiplostim N01

Qilu Pharmaceutical Co., Ltd.

Phase 3

1 5

PLB1004

AAvistone Biotechnology Co., Ltd.

Phase 3

1 6

TLL-018

HHangzhou Highlightll Pharmaceutical Co., Ltd

Phase 3

1 7

Ralinepag

United Therapeutics

Phase 3

2 8

Sodium Oligomannate

GGreen Valley (Shanghai) Pharmaceuticals Co., Ltd.

Phase 3

2 9

DFL24498

DDompé Farmaceutici S.p.A

Phase 3

1 10

EB-1020

Otsuka

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

N/ANot yet recruiting

Thrombocytopenia

NCT07162519

Phase 2Recruiting

Hematologic Malignancies

NCT06693791

Q1 2027

Phase 2Recruiting

Cancer Treatment-Induced Thrombocytopenia (CTIT)

NCT06898983

Q3 2027

N/ARecruiting

Immune Thrombocytopenia

NCT07206823

Q4 2027

Phase 1Recruiting

Romiplostim N01

NCT07321626

Clinical

Trials by Indication[1]

Thrombocytopenia6 trials

Romiplostim N01 for the Treatment of Thrombocytopenia Associated With Radiotherapy-Combined Treatment Regimens in Patients With Solid Tumors

Not yet recruiting·ZZhujiang Hospital·Phase 2·NCT07128576·60 enrolled

Romiplostim N01 in the Treatment of Thrombocytopenia Caused by Cytotoxic Drugs in Breast Cancer Patients

Not yet recruiting·TTianjin Medical University Cancer Institute and Hospital·N/A·NCT07162519·68 enrolled

Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia in Pediatric Cancer Patients

Not yet recruiting·—·Phase 2·NCT07043894·50 enrolled

Show 3 more trials

Romiplostim N01 for Chemotherapy-induced Thrombocytopenia

Recruiting·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT07063225·50 enrolled

A Multicenter, Open-label, Randomized Controlled Trial Evaluating the Efficacy and Safety of Romiplostim N01 in the Treatment of Thrombocytopenia Associated With Concurrent/Sequential Chemoradiotherapy and Chemotherapy Combined With/Without Immunotherapy in Solid Tumors

Not yet recruiting·JJun Wang·N/A·NCT07185893·106 enrolled

A Prospective Clinical Study on the Efficacy and Safety of Romiplostim N01 for Injection for Secondary Prophylaxis in Breast Cancer Patients With Chemotherapy-Induced Thrombocytopenia (CIT)

Not yet recruiting·FFudan University·Phase 2·NCT07771881·53 enrolled

Immune Thrombocytopenia2 trials

Phase II Study of Orelabrutinib in Combination With Romiplostim N01 in Patients With Primary Immune Thrombocytopenia (ITP) Who Have Received At Least One Prior Line of Therapy

Not yet recruiting·PPeking Union Medical College Hospital·Phase 2·NCT07400250·28 enrolled

Efficacy and Safety of Romiplostim N01 Combined With Rituximab in Patients With Oral TPO-RA-Refractory Primary Immune Thrombocytopenia

Recruiting·TThe First Affiliated Hospital of Soochow University·N/A·NCT07206823·30 enrolled

Romiplostim N012 trials

A Multicenter Randomized Controlled Study on the Treatment of Refractory CTIT With Romiplostim N01 Compared to Recombinant Human Thrombopoietin

Not yet recruiting·SShandong University·Phase 3·NCT06440824·60 enrolled

Romiplostim N01 for Platelet Recovery After Haploidentical HSCT

Recruiting·FFirst Affiliated Hospital of Zhejiang University·Phase 1·NCT07321626·130 enrolled

Severe Aplastic Anemia1 trial

A Study of Romiplostim N01 Plus IST vs. Placebo Plus IST for Treatment-Naive Severe Aplastic Anemia

Not yet recruiting· Qilu Pharmaceutical Co., Ltd. logo

Qilu Pharmaceutical Co., Ltd.·Phase 3·NCT07345000·210 enrolled

Efficacy and Safety1 trial

FRIENDS-01：A Multicenter Open-label Randomized Controlled Study on the Treatment of CTIT of the Efficacy and Safety With Romiplostim N01 Compared to Recombinant Human Interleukin-11

Not yet recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 3·NCT06759636·88 enrolled

2 more indications

Hematologic Malignancies1 trial

Romiplostim N01 for Platelet Recovery in Adult Hematologic Malignancies Patients Undergoing UCBT

Recruiting·—·Phase 2·NCT06693791·34 enrolled

Cancer Treatment-induced Thrombocytopenia (CTIT)1 trial

Efficacy and Safety Study of Romiplostim N01 for Cancer Treatment-induced Thrombocytopenia (CTIT) in the Treatment of Leukemia

Recruiting·AAnhui Provincial Hospital·Phase 2·NCT06898983·97 enrolled

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for Romiplostim N01. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Romiplostim N01 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Romiplostim N01. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Qilu Pharmaceutical Co., Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Protein / enzyme[2]
Highest Phase: Phase 3[1]
Company: Qilu Pharmaceutical Co., Ltd.

Romiplostim N01

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q3 2027

Q4 2027

Trials by Indication[1]

Thrombocytopenia6 trials

Immune Thrombocytopenia2 trials

Romiplostim N012 trials

Severe Aplastic Anemia1 trial

Efficacy and Safety1 trial

Hematologic Malignancies1 trial

Cancer Treatment-induced Thrombocytopenia (CTIT)1 trial

References

Drug Info

Quick Facts

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