MULPLETA (lusutrombopag)
MULPLETA is indicated for the treatment of Thrombocytopenia; Chronic Liver Disease.
How MULPLETA Works
Lusutrombopag is an orally bioavailable, small-molecule thrombopoietin (TPO) receptor agonist. It interacts with the transmembrane domain of human TPO receptors expressed on hematopoietic stem cells and megakaryocytic progenitor cells. This interaction induces the proliferation and differentiation of these progenitors and promotes megakaryocyte maturation, resulting in an increase in endogenous platelet production.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-07-31
- Patent Cliff
- 2031
- Routes
- ORAL
- Dosage Forms
- TABLET
MULPLETA Approval History
What MULPLETA Treats
2 indicationsMULPLETA is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Thrombocytopenia
- Chronic Liver Disease
MULPLETA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in MULPLETA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications MULPLETA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to MULPLETA
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06426043 | LNA-2024 | Ph 4 | not yet recruiting | A Prospective Study on the Treatment of Recurrent/Refractory/Intolerable NSAA With Lusutrombopag |
| NCT01054443 results posted | 0913M0621 | Ph 2 | terminated | A Study to Investigate the Efficacy and Safety of Lusutrombopag (S-888711) Tablets Administered to Adults With Immune Thrombocytopenia (ITP) |
| NCT01129024 results posted | 0914M0622 | Ph 2 | terminated | An Open-label Safety Study of Lusutrombopag (S-888711) in Adults With Chronic Immune Thrombocytopenia (ITP) |
| NCT02389621 L-PLUS 2 results posted | 1423M0634 2014-004942-91 | Ph 3 | completed | Safety and Efficacy Study of Lusutrombopag for Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Elective Invasive Procedures |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MULPLETA FDA Label Details
Indications & Usage
FDA Label (PDF)MULPLETA is indicated for the treatment of Thrombocytopenia; Chronic Liver Disease.
Pro Intelligence Preview
Deep insights for MULPLETA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 3 active patents
Trial Analysis
- • 4 total trials
- • Stage: Stable
Competitive Landscape
- • 9 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment