AFATINIB DIMALEATE · HETERO LABS LTD V
AFATINIB DIMALEATE is FDA-approved to treat 1 condition (same as GILOTRIF).
Development Insights
Details
- Status
- Prescription
- First Approved
- 2013-07-12
- Routes
- ORAL
- Dosage Forms
- TABLET
AFATINIB DIMALEATE Approval History
What AFATINIB DIMALEATE Treats
1 indicationsAFATINIB DIMALEATE is approved for 1 conditions since its original approval in 2026. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as GILOTRIF (same active ingredient).
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02465060 | NCI-2015-00054 NCI-2015-00054, EAY131 | Ph 2 | active not recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) |
| NCT04439136 results posted | NCI-2020-03140 NCI-2020-03140, EAY131-B | Ph 2 | active not recruiting | Testing Afatinib as a Potential Targeted Treatment in Cancers With HER2 Genetic Changes (MATCH-Subprotocol B) |
| NCT02438722 results posted | S1403 NCI-2014-02405, BI 1200.124 | Ph 2, Ph 3 | completed | S1403, Afatinib Dimaleate With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage IV or Recurrent, EGFR Mutation Positive Non-small Cell Lung Cancer |
| NCT02122172 results posted | 13-0540 NCI-2014-00859, IRB13-0540 | Ph 2 | terminated | Afatinib in Advanced Refractory Urothelial Cancer |
| NCT02364609 results posted | 704874 UCDCC#250, 1200.237 | Ph 1 | completed | Pembrolizumab and Afatinib in Patients With Non-small Cell Lung Cancer With Resistance to Erlotinib |
| NCT02451553 | 9078 NCI-2015-00684, 9078 | Ph 1 | completed | Afatinib Dimaleate and Capecitabine in Treating Patients With Advanced Refractory Solid Tumors, Pancreatic Cancer or Biliary Cancer |
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.
AFATINIB DIMALEATE FDA Label Details
Indications & Usage
AFATINIB DIMALEATE is FDA-approved to treat 1 condition — same approved indications as GILOTRIF.
Looking for the branded version?
GILOTRIF
Full clinical data, patents, trials, and competitive landscape for afatinib dimaleate.
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