Rhofade

(Oxymetazoline)

ApprovedSmall molecule

KKenvue Brands

Rhofade is one of 53 small molecule programs targeting Rhinitis. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

RhinitisActive, not recruiting

SleepUnknown status

Nasal ObstructionRecruiting

Allergic RhinitisCompleted

RhinitisApproved

Active, not recruiting

SleepPreclinical

Unknown status

Nasal ObstructionPhase 2

Recruiting

Allergic RhinitisApproved

Completed

Competition

Competitive Landscape

52 competitors in Allergic Rhinitis

#DrugCompanyPhaseTrials

Singulair

OOrganon and Co

Approved

13 2

Flovent

PParatek Pharmaceuticals Inc

Approved

12 3

Xyzal

CChattem

Approved

11 4

Alvesco

AAzurity Pharmaceuticals

Approved

8 5

Claritin

PPerrigo Company

Approved

6 6

Zyrtec

KKenvue Brands

Approved

5 7

Pulmicort

SSalix

Approved

5 8

Clarinex

OOrganon and Co

Approved

5 9

Qvar

SSchering-Plough

Approved

4 10

Allegra

CChattem

Approved

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

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Nasal Obstruction

NCT06830109

Clinical

Trials by Indication[1]

Allergic Rhinitis4 trials

NoAL (HPMC) in Combination With Oxymetazoline in Patients With Allergic Rhinitis

Completed·AAssociation Asthma, Bulgaria·Phase 2·NCT01986582·40 enrolled

Study to Assess the Effects of Allergic Rhinitis and Co-administration of Mometasone or Oxymetazoline on the Pharmacokinetics, Safety, and Tolerability of Intranasal Esketamine

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02154334·47 enrolled

Preventing Tolerance to Oxymetazoline in Allergic Rhinitis

Withdrawn·BBrian J Lipworth·Phase 4·NCT00846326

Show 1 more trial

Intranasal Steroids and Oxymetazoline in Allergic Rhinitis

Completed·UUniversity of Chicago·Phase 4·NCT00584987·64 enrolled

Hemodynamic2 trials

Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

Withdrawn·RRichard Cartabuke·Phase 2·NCT02062996

Prospective Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption

Completed·RRichard Cartabuke·N/A·NCT02453841·30 enrolled

Rhinitis1 trial

Effectiveness of Oxymetazoline Added on Nasal Steroid in Rhinitis With Persistent Nasal Obstruction

Completed·MMahidol University·Phase 4·NCT01847131·50 enrolled

Sinus Surgery1 trial

Comparing Blood Loss and Visualization After the Preoperative Use of Topical 0.05% Oxymetazoline Versus 1:1000 Epinephrine Prior to Endoscopic Sinus Surgery

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT03228914·20 enrolled

Adult1 trial

Intra-anal Oxymetazoline in Healthy Adult Volunteers

Unknown status·RRDD Pharma Ltd·Phase 1·NCT03529487·40 enrolled

8 more indications

Common Cold1 trial

A Study of Nasal Glucagon in Participants With a Common Cold

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02778100·36 enrolled

Spinal Cord Injury1 trial

The Effect of Oxymetazoline Gel on Anal Pressure and Incontinence in Spinal Cord Injury Patients

Completed·RRDD Pharma Ltd·Phase 1/2·NCT02299557·19 enrolled

Epistaxis1 trial

Epinephrine Nasal Drops for Epistaxis During Nasal Intubation

Completed·UUniversitas Padjadjaran·Phase 2·NCT06789549·40 enrolled

Seasonal Allergic Rhinitis1 trial

Study of Mometasone Furoate Nasal Spray and Oxymetazoline Nasal Spray Given Together Once A Day To Treat Seasonal Allergic Rhinitis (P04500)

Completed·OOrganon and Co·Phase 2·NCT00552110·707 enrolled

Nasal Obstruction1 trial

Nasal Obstruction With Oxymetazoline and Corticosteroids

Recruiting·WWashington University School of Medicine·Phase 2·NCT06830109·80 enrolled

Sleep1 trial

The Effects of Nasal Airflow on Upper Airway Dilator Muscles During Sleep

Unknown status·—·N/A·NCT03506178·30 enrolled

Erythema1 trial

An Evaluation of the Reduction in Erythema in Adult Patients With Moderate to Severe Persistent Facial Erythema Associated With Rosacea

Completed·PPadagis LLC·Phase 3·NCT03352323·50 enrolled

Unspecified1 trial

TransMEM Gas Exchange -- Project 1, Aim 2

Completed·—·Phase 1·NCT01925729·84 enrolled

Regulatory

FDA Approval Timeline[4]

May 30, 1986

OCUCLEAR

NDA NDA018471

Mar 31, 1989

VISINE L.R.

NDA NDA019407

Jan 18, 2017

RHOFADE

NDA NDA208552

Jul 8, 2020

UPNEEQ

NDA NDA212520

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Oxymetazoline. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Oxymetazoline compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Oxymetazoline. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA212520). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Rhofade. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Kenvue Brands company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: KKenvue Brands

Patent Landscape[5]

Patent Cliff

May 2, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7812049May 2, 2028

10912765Aug 26, 2031

8357714Aug 26, 2031

9867808Aug 26, 2031

8883838Dec 1, 2031

16 more patents

12350255Jun 11, 2035

11517560Jun 11, 2035

10335391Jun 11, 2035

10751325Jun 11, 2035

9974773Jun 11, 2035

12648930Dec 15, 2039

11701343Dec 16, 2039

10799481Dec 16, 2039

10940138Dec 16, 2039

10898573Dec 16, 2039

10814001Dec 16, 2039

11311515Dec 16, 2039

11541036Dec 16, 2039

11103482Dec 16, 2039

12605363Dec 16, 2039

11324722Dec 16, 2039

Rhofade

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Allergic Rhinitis4 trials

Hemodynamic2 trials

Rhinitis1 trial

Sinus Surgery1 trial

Adult1 trial

Common Cold1 trial

Spinal Cord Injury1 trial

Epistaxis1 trial

Seasonal Allergic Rhinitis1 trial

Nasal Obstruction1 trial

Sleep1 trial

Erythema1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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