Sterile Urea

(Urea)

Phase 1Small molecule

Pfizer

Sterile Urea is one of 28 small molecule programs targeting Hand-foot syndrome. It is currently in Phase 1.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Hand-Foot SyndromeActive, not recruiting

Subarachnoid HemorrhageActive, not recruiting

Onychomycosis of ToenailRecruiting

Hand-Foot SyndromePreclinical

Active, not recruiting

Subarachnoid HemorrhagePreclinical

Active, not recruiting

Onychomycosis of ToenailPhase 1

Recruiting

Competition

Competitive Landscape

34 competitors in Subarachnoid Hemorrhage

#DrugCompanyPhaseTrials

Keppra

UCB

Approved

1 2

Cardene

Sun Pharmaceutical Industries, Inc.

Approved

1 3

Olumiant

Pletal

2 5

Xylocaine

MMEDRx USA, Inc.

Approved

2 6

Neurontin

VViatris Specialty LLC

Approved

1 7

Heparin Sodium

BBaxter Healthcare Corporation

Approved

—8

Ketalar

AAultman Health Foundation

Approved

—9

Angiomax

BBaxter Healthcare Corporation

Marcaine

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

Timeline

Expected Milestones

Q4 2027

Phase 1Recruiting

Onychomycosis of Toenail

NCT07756671

Clinical

Trials by Indication[1]

Low Birth Weight1 trial

Gluconeogenesis in Very Low Birth Weight Infants Who Are Receiving Nutrition By Intravenous Infusion

Unknown status·NNational Center for Research Resources (NCRR)·N/A·NCT00005889·96 enrolled

Hyponatremia1 trial

Urea for Chronic Hyponatremia

Terminated·HHelbert Rondon Berrios, MD, MS·Phase 2·NCT04588207·2 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Runzao Zhiyang Capsule to Treat Chronic Eczema

Unknown status·GGuizhou Tongjitang Pharmaceutical Co.,Ltd·Phase 4·NCT02601222·240 enrolled

Onychomycosis1 trial

Treatment of Onychomycosis With Loceryl (Amorolfine) Nail Lacquer 5% Versus a Two-course Treatment With Urea 40% Ointment and Bifonazole Cream 1%

Completed·GGalderma R&D·Phase 4·NCT02705664·22 enrolled

Hand-foot syndrome1 trial

The Efficacy and Safety of Liangxue Ointment in the Treatment of Hand-foot Syndrome Caused by VEGFR-TKI Drugs

Recruiting·PPeking University Cancer Hospital & Institute·N/A·NCT06583369·220 enrolled

7 more indications

Radiodermatitis1 trial

Management Radiodermatitis in Patients With Breast or Head and Neck Cancer

Completed·UUniversity of Brasilia·Phase 3·NCT02247830·48 enrolled

Capecitabine1 trial

Urea Cream Prevention for Capecitabine Associated Hand Foot Syndrome

Unknown status·MMahidol University·Phase 2/3·NCT05348278·214 enrolled

Atopic Eczema1 trial

Skin Tolerance Study of Betamethasone Creams in Atopic Eczema and the Preventative Properties of a Moisturiser

Completed·AACO Hud Nordic AB·Phase 3·NCT00576238·55 enrolled

MPA1 trial

Comparison of 12% Ammonium Lactate and 10% Urea Cream in Geriatric With Xerosis Cutis

Completed·IIndonesia University·Phase 3·NCT04127513·40 enrolled

Recurrence1 trial

A Randomised Trial of a Moisturising Cream in Preventing Recurrence of Hand Eczema

Completed·AACO Hud Nordic AB·Phase 4·NCT00576550·53 enrolled

Subarachnoid Hemorrhage1 trial

Urea Therapy for Hyponatremia in Subarachnoid Hemorrhage

Active, not recruiting·UUniversity Hospital, Grenoble·N/A·NCT04552873·52 enrolled

Onychomycosis of Toenail1 trial

Photodynamic Therapy For Onychomycosis: An Open Label Study

Recruiting·TThe University of Texas Health Science Center, Houston·Phase 1·NCT07756671·5 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

STERILE UREA

NDA NDA017698

Jan 1, 1982

UREAPHIL

NDA NDA012154

Sources

References

[1]
ClinicalTrials.gov — 12 trial records for Urea. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Urea compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Urea. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA017698). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 1[1]
Company: Pfizer

Sterile Urea

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2027

Trials by Indication[1]

Low Birth Weight1 trial

Hyponatremia1 trial

Efficacy and Safety1 trial

Onychomycosis1 trial

Hand-foot syndrome1 trial

Radiodermatitis1 trial

Capecitabine1 trial

Atopic Eczema1 trial

MPA1 trial

Recurrence1 trial

Subarachnoid Hemorrhage1 trial

Onychomycosis of Toenail1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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