Romiplostim N01

Phase 3Protein / enzyme

Qilu Pharmaceutical Co., Ltd.

Romiplostim N01 is one of 99 small molecule programs targeting Thrombocytopenia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

ThrombocytopeniaActive, not recruiting

Severe Aplastic AnemiaActive, not recruiting

Immune ThrombocytopeniaActive, not recruiting

Cancer Treatment-Induced Thrombocytopenia (CTIT)Recruiting

ThrombocytopeniaPhase 2

Active, not recruiting

Severe Aplastic AnemiaPhase 3

Active, not recruiting

Immune ThrombocytopeniaPreclinical

Active, not recruiting

Cancer Treatment-Induced Thrombocytopenia (CTIT)Phase 2

Recruiting

Competition

Competitive Landscape

135 competitors in Immune Thrombocytopenia

#DrugCompanyPhaseTrials

Nplate

Amgen

Phase 3

8 2

Rysodeg

UCB

Phase 3

3 3

Cellcept

Roche

Phase 3

2 4

Doptelet

AAkarx

Phase 3

6 5

Vyvgart

Argenx

Phase 3

6 6

Fabhalta

Johnson & Johnson

Phase 3

—7

Wayrilz

GGenzyme, a Sanofi Company

Phase 3

3 8

Nublexa

BBeijing InnoCare Pharma Tech Co., Ltd.

Phase 3

3 9

Tamiflu

CConrado Roberto Hoffmann Filho

Phase 3

1 10

Avlosulfon

AAlmirall, S.A.

Phase 3

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

Timeline

Expected Milestones

Q3 2026

Phase 3Not yet recruiting

Efficacy and Safety

NCT06759636

Phase 2Recruiting

Thrombocytopenia

NCT07063225

Phase 2Not yet recruiting

Thrombocytopenia

NCT07043894

Q4 2026

N/ANot yet recruiting

Thrombocytopenia

NCT07162519

Phase 2Recruiting

Hematologic Malignancies

NCT06693791

Q1 2027

Phase 2Recruiting

Cancer Treatment-Induced Thrombocytopenia (CTIT)

NCT06898983

Clinical

Trials by Indication[1]

Thrombocytopenia5 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

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

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

Show 2 more trials

Romiplostim N01 for Chemotherapy-Induced Thrombocytopenia in Pediatric Cancer Patients

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

Romiplostim N01 for Chemotherapy-induced Thrombocytopenia

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

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

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

Hematologic Malignancies1 trial

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

Recruiting·—·Phase 2·NCT06693791·34 enrolled

2 more indications

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

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 — 13 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

Q3 2026

Q4 2026

Q1 2027

Trials by Indication[1]

Thrombocytopenia5 trials

Romiplostim N012 trials

Immune Thrombocytopenia2 trials

Severe Aplastic Anemia1 trial

Hematologic Malignancies1 trial

Efficacy and Safety1 trial

Cancer Treatment-induced Thrombocytopenia (CTIT)1 trial

References

Drug Info

Quick Facts

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