Eflornithine Hydrochloride

Lowers the risk of relapse. Sold as Ornidyl, Vaniqa, Iwilfin. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 3 applications for Eflornithine Hydrochloride (sold as Ornidyl, Vaniqa, Iwilfin), first approved Nov 28, 1990, with 0 new uses approved and 0 published complete response letters.

First approved: Nov 28, 1990
Applications: 3
New uses approved: 0
Complete response letters: 0
Orphan exclusivity until: Dec 13, 2030
First approved in the EU: Mar 19, 2001

Orphan Designations (FDA)

5 designations, 1 approved for the designated use; see all orphan designations

Treatment of neuroblastomaUSWM, LLC · designated Nov 22, 2017 · approved Dec 13, 2023 · exclusive to Dec 13, 2030
Treatment of pancreatic cancer.Panbela Therapeutics, Inc. · designated Dec 14, 2016
Treatment of Familial Adenomatous PolyposisPanbela Therapeutics, Inc. · designated Feb 4, 2011
Treatment of neuroblastomaCancer Prevention Pharmaceuticals · designated Nov 23, 2010
Treatment of anaplastic gliomaOrbus Therapeutics, Inc. · designated Sep 29, 2006

Approvals in the EU (EMA)

First approved in the EU 124 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Vaniqa, new substanceAlmirall, S.A. · Mar 19, 2001

Clinical Trials

17 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade GliomasAnaplastic Oligodendroglioma, Astrocytoma, IDH-Mutant, Grade 3 · Mayo Clinic	Phase 1 / Phase 2	Recruiting	Mar 12, 2026
Eflornithine (DFMO) for Ewing Sarcoma and OsteosarcomaOsteosarcoma, Ewing Sarcoma · Milton S. Hershey Medical Center	Phase 2	Recruiting	Jan 7, 2026
Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid TumorsMelanoma (Skin Cancer), HER2-low Hormone Receptor Positive Breast Cancer · Aminex Therapeutics, Inc.	Phase 1 / Phase 2	Recruiting	Dec 17, 2025
Clinical Study of Eflornithine After Immunotherapy for High-risk Neuroblastoma（CSHEIN）High Risk Neuroblastoma · Shanghai Children's Hospital	—	Active, not recruiting	Dec 12, 2025
Comparison of a Face Cream Plus a Laser Procedure and Face Cream Alone in Treatment of Excessive Face Hairs in FemaleHirsuitism · Khyber Teaching Hospital	Phase 4	Recruiting	May 16, 2025
DFMO Maintenance for Patients With Relapsed/Refractory Ewing Sarcoma or OsteosarcomaOsteosarcoma Recurrent, Ewing's Tumor Recurrent · Montefiore Medical Center	Phase 1 / Phase 2	Recruiting	Mar 25, 2025
Eflornithine (DFMO) and AMXT 1501 for Neuroblastoma, CNS Tumors, and SarcomasAtypical Teratoid/Rhabdoid Tumor, Embryonal Tumor With Multilayered Rosettes · Milton S. Hershey Medical Center	Phase 1 / Phase 2	Recruiting	Jun 18, 2024
Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate CancerProstate Cancer · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2	Recruiting	Sep 28, 2023

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Nov 28, 1990	OrnidylNDA 19879 · New molecular entity	Sanofi Aventis US	2	Discontinued
Jul 27, 2000	VaniqaNDA 21145 · New dosage form	Abbvie	7	Discontinued
Dec 13, 2023	IwilfinNDA 215500 · New formulation or manufacturer	Uswm	1	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA