Mulpleta

(Lusutrombopag)

Phase 3Small molecule

IItalian Network for Tumor Biotherapy Foundation

Mulpleta is one of 73 small molecule programs targeting Thrombocytopenia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

ThrombocytopeniaActive, not recruiting

Immune ThrombocytopeniaActive, not recruiting

ThrombocytopeniaPhase 3

Active, not recruiting

Immune ThrombocytopeniaPhase 2

Active, not 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

Vyvgart

Argenx

Phase 3

6 5

Doptelet

AAkarx

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

Q1 2028

N/ARecruiting

Allogeneic Hematopoietic Stem Cell Transplantation

NCT07483385

Clinical

Trials by Indication[1]

Immune Thrombocytopenia3 trials

A Study to Investigate the Efficacy and Safety of Lusutrombopag (S-888711) Tablets Administered to Adults With Immune Thrombocytopenia (ITP)

Terminated· Shionogi logo

Shionogi·Phase 2·NCT01054443·20 enrolled

An Open-label Safety Study of Lusutrombopag (S-888711) in Adults With Chronic Immune Thrombocytopenia (ITP)

Terminated· Shionogi logo

Shionogi·Phase 2·NCT01129024·19 enrolled

Lusutrombopag in the Treatment of Immune Thrombocytopenia (ITP)

Completed·IInstitute of Hematology & Blood Diseases Hospital, China·Phase 2·NCT06287567·17 enrolled

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

Efficacy and Safety of Lusutrombopag After Allogeneic Hematopoietic Stem Cell Transplantation

Recruiting·TThe General Hospital of Western Theater Command·N/A·NCT07483385·45 enrolled

Thrombocytopenia1 trial

Safety and Efficacy Study of Lusutrombopag for Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Elective Invasive Procedures

Completed· Shionogi logo

Shionogi·Phase 3·NCT02389621·215 enrolled

Prospective1 trial

A Prospective Study on the Treatment of Recurrent/Refractory/Intolerable NSAA With Lusutrombopag

Not yet recruiting·PPeking Union Medical College Hospital·Phase 4·NCT06426043·40 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 31, 2018

MULPLETA

NDA NDA210923

Sources

References

[1]
ClinicalTrials.gov — 6 trial records for Lusutrombopag. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Lusutrombopag compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Lusutrombopag. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA210923). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Mulpleta. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Italian Network for Tumor Biotherapy Foundation company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: IItalian Network for Tumor Biotherapy Foundation

Patent Landscape[5]

Patent Cliff

Jul 29, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8889722Jul 29, 2028

8530668Jan 21, 2030

9427402Sep 29, 2031

Mulpleta

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2028

Trials by Indication[1]

Immune Thrombocytopenia3 trials

Allogeneic Hematopoietic Stem Cell Transplantation1 trial

Thrombocytopenia1 trial

Prospective1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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