Ornidyl

(Eflornithine)

ApprovedSmall molecule

Eflornithine is used to treat sleeping sickness (a serious parasitic disease transmitted by tsetse flies in Africa) and to reduce unwanted facial hair growth in women.[2] Ornidyl is currently approved and in use across 29 indications[4].[1]

Ornidyl is one of 575 small molecule programs targeting Glioma. It is currently in Approved.

Indications

Total Trials

Active Trials

574

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

GliomaActive, not recruiting

Familial Adenomatous PolyposisActive, not recruiting

LeishmaniasisActive, not recruiting

Human African TrypanosomiasisActive, not recruiting

Esophageal CancerApproved

Precancerous ConditionApproved

Anaplastic AstrocytomaActive, not recruiting

OsteosarcomaRecruiting

Skin CancerActive, not recruiting

Colon CarcinomaApproved

GliomaPhase 1

Active, not recruiting

Familial Adenomatous PolyposisPhase 3

Active, not recruiting

LeishmaniasisApproved

Active, not recruiting

Human African TrypanosomiasisPhase 3

Active, not recruiting

Esophageal CancerApproved

Approved

Precancerous ConditionApproved

Approved

Anaplastic AstrocytomaPhase 3

Active, not recruiting

OsteosarcomaPhase 2

Recruiting

Skin CancerPhase 3

Active, not recruiting

Colon CarcinomaApproved

Approved

Showing 10 of 29 indications

Competition

Competitive Landscape

1399 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Ornidyl

UUSWM, LLC (dba US WorldMeds)

Approved

2 2

Mekinist

Novartis

Preclinical

3 3

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

2 4

Ranexa

MMenarini International Operations Luxembourg SA

Preclinical

1 5

Viagra

VViatris Specialty LLC

Preclinical

1 6

Triptorelin Pamoate

Ipsen

Preclinical

2 7

Therapeutic Hydrocortisone

EEastern Cooperative Oncology Group

Preclinical

9 8

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

—9

Osmitrol

BB. Braun Medical Inc.

Xylocaine

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 1Recruiting

Glioma

NCT05717153

Q4 2030

PreclinicalRecruiting

Anaplastic Oligodendroglioma

NCT07468136

Q4 2033

Phase 2Active, not recruiting

Neuroblastoma

NCT04301843

Q2 2035

PreclinicalRecruiting

Atypical Teratoid/rhabdoid Tumor

NCT06465199

Clinical

Trials by Indication[1]

Familial adenomatous polyposis2 trials

Trial of Eflornithine Plus Sulindac in Patients With Familial Adenomatous Polyposis (FAP)

Completed·CCancer Prevention Pharmaceuticals, Inc.·Phase 3·NCT01483144·171 enrolled

Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00033371·205 enrolled

Colorectal Cancer2 trials

Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00983580·107 enrolled

Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00118365·375 enrolled

Human African Trypanosomiasis2 trials

Efficacy - Safety of Eflornithine-Nifurtimox Combination Versus Eflornithine to Treat Human African Trypanosomiasis

Completed·DDrugs for Neglected Diseases·Phase 3·NCT00146627·280 enrolled

Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2

Completed·DDrugs for Neglected Diseases·Phase 2/3·NCT01685827·394 enrolled

Prostate Cancer2 trials

Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer

Completed·—·Phase 2·NCT00006101·76 enrolled

Neoadjuvant Eflornithine and Bicalutamide Compared With Eflornithine Alone, Bicalutamide Alone, and No Neoadjuvant Therapy in Treating Patients With Localized Prostate Cancer Undergoing Brachytherapy or Radical Prostatectomy

Completed·UUniversity of Alabama at Birmingham·Phase 2·NCT00086736·34 enrolled

Folliculitis1 trial

Topical Eflornithine for Pseudofolliculitis Barbae: Randomized Controlled Trial

Terminated·WWalter Reed National Military Medical Center·Phase 4·NCT04403282·9 enrolled

14 more indications

Treatment1 trial

Comparison of a Face Cream Plus a Laser Procedure and Face Cream Alone in Treatment of Excessive Face Hairs in Female

Recruiting·KKhyber Teaching Hospital·Phase 4·NCT06976424·122 enrolled

Actinic Keratosis1 trial

Eflornithine With or Without Triamcinolone in Preventing Nonmelanoma Skin Cancer in Patients With Actinic Keratosis

Completed·UUniversity of Arizona·Phase 2·NCT00021294

Glioblastoma1 trial

Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma

Recruiting·OOrbus Therapeutics, Inc.·Phase 1·NCT05879367·66 enrolled

Barrett's esophagus1 trial

Eflornithine to Prevent Cancer in Patients With Barrett's Esophagus

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT00003076·152 enrolled

Prevention1 trial

Chemoprevention of Gastric Carcinogenesis

Completed·VVanderbilt-Ingram Cancer Center·Phase 2·NCT02794428·91 enrolled

Cervical Intraepithelial Neoplasia1 trial

Eflornithine To Prevent Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00006079·150 enrolled

Skin Cancer1 trial

Eflornithine to Prevent Skin Cancer in Patients With Previously Treated Early Stage Skin Cancer

Completed·UUniversity of Wisconsin, Madison·Phase 3·NCT00005884

Bladder Cancer1 trial

Eflornithine in Treating Patients With Bladder Cancer

Completed·NNational Cancer Institute (NCI)·Phase 3·NCT00003814·450 enrolled

Anaplastic Astrocytoma1 trial

Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients

Unknown status·OOrbus Therapeutics, Inc.·Phase 3·NCT02796261·343 enrolled

Glioma1 trial

Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma

Recruiting·MMayo Clinic·Phase 1·NCT05717153·18 enrolled

Osteosarcoma1 trial

A Phase II Open Label Basket Trial Study Using Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma

Recruiting·MMilton S. Hershey Medical Center·Phase 2·NCT07321912·406 enrolled

Neuroblastoma1 trial

Phase II Trial of Eflornithine (DFMO) and Etoposide for Relapsed/Refractory Neuroblastoma

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04301843·131 enrolled

Atypical Teratoid/Rhabdoid Tumor1 trial

A Phase I/II Study Using Eflornithine (DFMO) and AMXT 1501 for Relapsed and Refractory Neuroblastoma, CNS Tumors, and Sarcomas

Recruiting·MMilton S. Hershey Medical Center·Preclinical·NCT06465199·289 enrolled

Anaplastic Oligodendroglioma1 trial

Phase I/IIa Trial of Retifanlimab and Difluoromethylornithine (DFMO) in Patients With Progressive High-Grade Glioma

Recruiting·MMayo Clinic·Preclinical·NCT07468136·33 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 28, 1990

ORNIDYL

NDA NDA019879

Jul 27, 2000

VANIQA

NDA NDA021145

Dec 13, 2023

IWILFIN

NDA NDA215500

Sources

References

[1]
ClinicalTrials.gov — 23 trial records for Eflornithine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Ornidyl drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Eflornithine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Eflornithine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA215500). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Ornidyl. U.S. Food & Drug Administration.
[7]
SEC EDGAR — USWM, LLC (dba US WorldMeds) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Ornithine Decarboxylase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: UUSWM, LLC (dba US WorldMeds)

Patent Landscape[6]

Patent Cliff

Feb 12, 2036

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12582625Feb 12, 2036

Ornidyl

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2030

Q4 2033

Q2 2035

Trials by Indication[1]

Familial adenomatous polyposis2 trials

Colorectal Cancer2 trials

Human African Trypanosomiasis2 trials

Prostate Cancer2 trials

Folliculitis1 trial

Treatment1 trial

Actinic Keratosis1 trial

Glioblastoma1 trial

Barrett's esophagus1 trial

Prevention1 trial

Cervical Intraepithelial Neoplasia1 trial

Skin Cancer1 trial

Bladder Cancer1 trial

Anaplastic Astrocytoma1 trial

Glioma1 trial

Osteosarcoma1 trial

Neuroblastoma1 trial

Atypical Teratoid/Rhabdoid Tumor1 trial

Anaplastic Oligodendroglioma1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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