IWILFIN (eflornithine hydrochloride)
Iwilfin is indicated to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB). It is used as maintenance therapy for patients who have demonstrated at least a partial response to prior multiagent, multimodality therapy, including anti-GD2 immunotherapy. By addressing minimal residual disease, the drug helps prevent or delay the return of the cancer following intensive primary treatment.
How IWILFIN Works
Eflornithine is an irreversible inhibitor of ornithine decarboxylase (ODC), the rate-limiting enzyme in polyamine biosynthesis and a transcriptional target of MYCN. Polyamines are essential for neoplastic transformation and cell proliferation. By inhibiting polyamine synthesis, eflornithine decreases the expression of oncogenic drivers MYCN and LIN28B and restores the balance of the LIN28/Let-7 metabolic pathway, which regulates cancer stem cells. This results in a cytostatic effect that suppresses neurosphere formation and delays tumor recurrence.
Details
- Status
- Prescription
- First Approved
- 2023-12-13
- Patent Cliff
- 2036
- Routes
- ORAL
- Dosage Forms
- TABLET
IWILFIN Approval History
What IWILFIN Treats
1 indicationsIWILFIN is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Neuroblastoma
IWILFIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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.
Drugs Similar to IWILFIN
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03794349 results posted | ANBL1821 NCI-2018-03377, ANBL1821 | Ph 2 | active not recruiting | Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma |
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.
IWILFIN FDA Label Details
Indications & Usage
FDA Label (PDF)IWILFIN is indicated for the treatment of Neuroblastoma.
IWILFIN Patents & Exclusivity
Patents (1 active)
Exclusivity
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Deep insights for IWILFIN
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 1 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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.