Olux

(Clobetasol)

Phase 2Small molecule

HHarrow Inc

Olux is one of 149 small molecule programs targeting Oral Lichen Planus. It is currently in Phase 2.

Indications

Total Trials

Active Trials

148

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Oral Lichen PlanusActive, not recruiting

PhlebitisActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

PsoriasisActive, not recruiting

Atopic DermatitisActive, not recruiting

Carcinoma, Non-Small-Cell LungActive, not recruiting

Oral Lichen PlanusPhase 2

Active, not recruiting

PhlebitisPhase 1/Phase 2

Active, not recruiting

Non-Small Cell Lung CancerPhase 2

Active, not recruiting

PsoriasisPreclinical

Active, not recruiting

Atopic DermatitisPhase 1

Active, not recruiting

Carcinoma, Non-Small-Cell LungPhase 2

Active, not recruiting

Competition

Competitive Landscape

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Olux

HHarrow Inc

Phase 2

15 2

Gemzar

GGynecologic Oncology Group

Preclinical

72 3

Lenvima

Eisai

Preclinical

6 4

Imjudo

AstraZeneca

Preclinical

5 5

Gilotrif

Boehringer Ingelheim

Preclinical

12 6

Ofev

Boehringer Ingelheim

Preclinical

7 7

Immunotherapy

Bristol-Myers Squibb

Preclinical

12 8

Remeron

OOrganon and Co

Preclinical

1 9

PD-1 Inhibitor

Johnson & Johnson

Preclinical

2 10

REGN2810

Regeneron

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Phase 1Recruiting

Atopic Dermatitis

NCT06504160

Q4 2027

Phase 2Recruiting

Oral Lichen Planus

NCT07100613

Q1 2029

Phase 2Recruiting

Psoriasis

NCT06742333

Q2 2030

Phase 2Active, not recruiting

Carcinoma, Non-Small-Cell Lung

NCT06120140

Clinical

Trials by Indication[1]

Psoriasis4 trials

Early Intervention in Plaque Psoriasis: is Bimekizumab Able to Delay Chronic Inflammation?

Recruiting·—·Phase 2·NCT06742333·40 enrolled

Mechanistically-based Optimization of UV Radiation Therapy in Psoriasis

Terminated·VVA Office of Research and Development·N/A·NCT00470392·9 enrolled

Effectiveness and Safety of Topical Halobetasol Propionate in the Treatment of Patients With Psoriasis

Completed·AAzidus Brasil·Phase 2/3·NCT00715975·140 enrolled

Show 1 more trial

Study to Evaluate Vectical in Combination With Clobex Spray to Treatment Plaque Psoriasis

Completed·EEmer, Jason, M.D.·Phase 4·NCT01205880·12 enrolled

Oral Lichen Planus3 trials

A Comparison of Photodynamic Therapy and Topical Clobetasol in Treatment of Oral Lichen Planus: a Split-Mouth Randomised Controlled Study

Completed·WWroclaw Medical University·Phase 2·NCT06752343·29 enrolled

Impact of Topical Clobetasol on Gingival Crevicular Fluid miRNAs in Subjects Affected by Oral Lichen Planus

Completed·UUniversity of Catania·N/A·NCT05818618·64 enrolled

Mucoadhesive Modified-Release Formulations for the Topical Treatment of Symptomatic Oral Lichen Planus

Recruiting·UUniversity of Palermo·Phase 2·NCT07100613·45 enrolled

Chronic Graft Versus Host Disease1 trial

Clinical Trial With Clobetasol and Dexamethasone for Topical Treatment of Oral Lesions of Chronic Graft-versus-host Disease

Completed·GGrupo de Estudos Multicentricos em Onco-Hematologia·Phase 3·NCT01699412·28 enrolled

Irritation1 trial

Efficacy of Glycerol, Two Topical Steroids, and a Topical Immune Modulator Against Skin Irritation

Unknown status·OOdense University Hospital·Phase 4·NCT00779792·36 enrolled

Steroid1 trial

Comparison Between Corticosteroid and Topical Steroids in the DRESS

Unknown status·AAssistance Publique - Hôpitaux de Paris·N/A·NCT01987076·112 enrolled

5 more indications

Effectiveness1 trial

Comparative Effectiveness Trial in the Treatment of Pediatric Plaque Morphea

Withdrawn·MMedical College of Wisconsin·Phase 1·NCT02680717

Phlebitis1 trial

Ointment Therapy and Prevention of Cannulation-Induced Superficial Phlebitis

Unknown status·KKomar University of Science and Technology·Phase 1/2·NCT04685031·110 enrolled

Vulvar Lichen Sclerosus1 trial

Tacrolimus Versus Clobetasol Propionate in the Treatment of Vulvar Lichen Sclerosus

Completed·DDeana Funaro·Phase 2·NCT00757874·56 enrolled

Carcinoma, Non-Small-Cell Lung1 trial

A Phase 2, Open-Label, Randomized Trial Evaluating the Impact of Enhanced Versus Standard Dermatologic Management on Selected Dermatologic Adverse Events Among Patients With Locally Advanced or Metastatic EGFR-Mutated NSCLC Treated First-Line With Amivantamab + Lazertinib

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT06120140·305 enrolled

Atopic Dermatitis1 trial

Safety and Efficacy of Topical Bacteriotherapy for Atopic Dermatitis Using Staphylococcus Hominis A9

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT06504160·86 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 27, 1985

TEMOVATE

NDA NDA019323

Dec 27, 1985

TEMOVATE

NDA NDA019322

Feb 22, 1990

TEMOVATE

NDA NDA019966

Apr 29, 1994

TEMOVATE

NDA NDA020337

Jun 17, 1994

TEMOVATE E

NDA NDA020340

May 26, 2000

OLUX

NDA NDA021142

Jul 24, 2003

CLOBEX

NDA NDA021535

Feb 5, 2004

CLOBEX

NDA NDA021644

Oct 27, 2005

CLOBEX

NDA NDA021835

Jan 12, 2007

OLUX E

NDA NDA022013

Nov 28, 2017

IMPOYZ

NDA NDA209483

May 19, 2020

IMPEKLO

NDA NDA213691

Mar 4, 2024

BYQLOVI

NDA NDA218158

Sources

References

[1]
ClinicalTrials.gov — 15 trial records for Clobetasol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Clobetasol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Clobetasol. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA218158). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Olux. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Harrow Inc company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: HHarrow Inc

Patent Landscape[5]

Patent Cliff

Aug 31, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10588914Aug 31, 2030

9956231Aug 31, 2030

11179465Aug 31, 2030

10064875Aug 31, 2030

9855334Mar 11, 2035

2 more patents

11376262May 9, 2036

10588913May 9, 2036

Olux

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2027

Q1 2029

Q2 2030

Trials by Indication[1]

Psoriasis4 trials

Oral Lichen Planus3 trials

Chronic Graft Versus Host Disease1 trial

Irritation1 trial

Steroid1 trial

Effectiveness1 trial

Phlebitis1 trial

Vulvar Lichen Sclerosus1 trial

Carcinoma, Non-Small-Cell Lung1 trial

Atopic Dermatitis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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