TheraRadar
Data updated: May 26, 2026

NILOTINIB HYDROCHLORIDE DIHYDRATE

Trial Activity: Declining 13 active trials
Oncology Approved 2025-11-19
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Novartis Pharmaceuticals conducting 40 trials (43%)
133 indications explored (Broad Platform)
→ chronic myeloid leukemia (20 trials)
→ chronic myelogenous leukemia (9 trials)
→ gastrointestinal stromal tumors (5 trials)
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
None (Tentative Approval)
First Approved
2025-11-19
Routes
N/A
Dosage Forms
CAPSULE

Companies

HETERO LABS LTD V
Active Ingredient: NILOTINIB HYDROCHLORIDE DIHYDRATE

NILOTINIB HYDROCHLORIDE DIHYDRATE Approval History

2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2025 to 2025
Nov 2025 ORIGINAL
Update
FDA Letter

What NILOTINIB HYDROCHLORIDE DIHYDRATE Treats

1 FDA approvals

Originally approved for its first indication in 2025 .

  • Other (1)
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

NILOTINIB HYDROCHLORIDE DIHYDRATE FDA Label Details

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Data Sources

FDA Approval: ANDA209651 → Trials: ClinicalTrials.gov →

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