Sterile Urea

(Urea)

Phase 3Small molecule

Pfizer

Sterile Urea is one of 123 small molecule programs targeting Atopic Eczema. It is currently in Phase 3.

Indications

Total Trials

Active Trials

122

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Atopic EczemaActive, not recruiting

Hand-Foot SyndromeActive, not recruiting

RadiodermatitisActive, not recruiting

Subarachnoid HemorrhageActive, not recruiting

HyponatremiaActive, not recruiting

Atopic EczemaPhase 3

Active, not recruiting

Hand-Foot SyndromePreclinical

Active, not recruiting

RadiodermatitisPhase 3

Active, not recruiting

Subarachnoid HemorrhagePreclinical

Active, not recruiting

HyponatremiaPhase 2

Active, not recruiting

Competition

Competitive Landscape

100 competitors in Subarachnoid Hemorrhage

#DrugCompanyPhaseTrials

Activase

Sterile Urea

1 3

Decadron

AAspen Global Incorporated

Phase 3

1 4

Precedex

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

Phase 3

1 5

Lipitor

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Phase 3

1 6

Avlosulfon

AAlmirall, S.A.

Phase 3

1 7

Ketalar

Boehringer Ingelheim

Phase 3

1 8

Desferal

Alnylam Pharmaceuticals

Phase 2

2 9

Dynastat

Pfizer

Phase 2

1 10

Primacor

Sanofi

Phase 2

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

Clinical

Trials by Indication[1]

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

Hyponatremia1 trial

Urea for Chronic Hyponatremia

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

Radiodermatitis1 trial

Management Radiodermatitis in Patients With Breast or Head and Neck Cancer

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

6 more indications

Capecitabine1 trial

Urea Cream Prevention for Capecitabine Associated Hand Foot Syndrome

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

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

MPA1 trial

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

Completed·IIndonesia University·Phase 3·NCT04127513·40 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

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

STERILE UREA

NDA NDA017698

Jan 1, 1982

UREAPHIL

NDA NDA012154

Sources

References

[1]
ClinicalTrials.gov — 11 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 3[1]
Company: Pfizer

Sterile Urea

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Recurrence1 trial

Subarachnoid Hemorrhage1 trial

Hyponatremia1 trial

Radiodermatitis1 trial

Efficacy and Safety1 trial

Capecitabine1 trial

Onychomycosis1 trial

Hand-foot syndrome1 trial

Low Birth Weight1 trial

MPA1 trial

Atopic Eczema1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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