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Drug

Lusutrombopag

Regulatory activity · EMA
Late-stage development

Also known as Mulpleta.

RxNorm2054984ChEMBLCHEMBL2107831UNII6LL5JFU42F
1
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Market withdrawal: Mulpleo (previously Lusutrombopag Shionogi) (EMA)

Regulatory2026-04-14EMA

Efficacy and Safety of Lusutrombopag After Allogeneic Hematopoietic Stem Cell Transplantation

Clinical trial2026-03-25Results expected Q1 2027 · ClinicalTrials.gov

An Exploratory Study on the Efficacy and Safety of Lusutrombopag in the Treatment of Recurrent/Refractory/Intolerable NSAA

Clinical trial2025-06-01Primary completion · ClinicalTrials.gov

An Open-label, Single-arm Study to Evaluate the Efficacy and Safety of Lusutrombopag in Chinese Adults With Persistent or Chronic Immune Thrombocytopenia

Clinical trial2025-03-06Completed · ClinicalTrials.gov

A Phase 3 Randomised, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of S-888711 (Lusutrombopag) for the Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Elective Invasive Procedures (L-PLUS 2)

Clinical trial2018-10-30Results posted · ClinicalTrials.gov

An Open-label Safety Study of S-888711 in Adult Subjects With Relapsed Persistent or Chronic Immune Thrombocytopenia With or Without Prior Splenectomy

Clinical trial2011-06-30Terminated · ClinicalTrials.gov

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of S-888711 Tablets Administered Once-daily for 42 Days to Adult Subjects With Relapsed Persistent or Chronic Immune Thrombocytopenia With or Without Prior Splenectomy

Clinical trial2010-11-24Terminated · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Lusutrombopag
Aliases & brands
Mulpleta
RxNorm CUI
2054984
ChEMBL ID
CHEMBL2107831
UNII
6LL5JFU42F
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2026-04-14Market withdrawalMarket
Market withdrawal: Mulpleo (previously Lusutrombopag Shionogi) (EMA)

Indication: Mulpleo is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

6 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
6
registered trials across all phases
LATEST COMPLETION 2025
1
Active studies
1
Recruiting
3
Late-stage (III+)
2
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 6
Phase 23Phase 31Phase 41Phase N / A1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.