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Celestone

(Betamethasone)

ApprovedSmall molecule

SSchering-Plough

Betamethasone is a steroid medication used to reduce inflammation and suppress the immune system, commonly prescribed for skin conditions like eczema and psoriasis, as well as allergic reactions and certain inflammatory disorders.[2] Celestone is currently approved and in use across 40 indications[4].[1]

Celestone is one of 596 small molecule programs targeting Premature Birth. It is currently in Approved.

40

Indications

52

Total Trials

2

Active Trials

595

Competitors

23

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Premature BirthApproved

Polymyalgia RheumaticaActive, not recruiting

Oral Lichen PlanusApproved

BronchiolitisActive, not recruiting

Carpal Tunnel SyndromeActive, not recruiting

ArthritisActive, not recruiting

AdenomaActive, not recruiting

Atopic EczemaApproved

TenosynovitisActive, not recruiting

HemorrhoidActive, not recruiting

Premature BirthApproved

Approved

Polymyalgia RheumaticaPreclinical

Active, not recruiting

Oral Lichen PlanusApproved

Approved

BronchiolitisPhase 2/Phase 3

Active, not recruiting

Carpal Tunnel SyndromePhase 3

Active, not recruiting

ArthritisPreclinical

Active, not recruiting

AdenomaPhase 1

Active, not recruiting

Atopic EczemaApproved

Approved

TenosynovitisApproved

Active, not recruiting

HemorrhoidApproved

Active, not recruiting

Showing 10 of 39 indications

Competition

Competitive Landscape

605 competitors in Psoriasis

#DrugCompanyPhaseTrials

Celestone

SSchering-Plough

Cosentyx

Stelara

Johnson & Johnson

Bimzelx

Humira

Raptiva

Remicade

OOrganon and Co

Siliq

BBausch Health Americas, Inc.

Lovenox

Olux

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

Timeline

Expected Milestones

Q2 2027

PreclinicalNot yet recruiting

Trigger Finger

NCT07681804

Q1 2029

Phase 2Not yet recruiting

Study completion

NCT07447739

Clinical

Trials by Indication[1]

Steroid3 trials

Effect of Antenatal Steroid on Pulmonary Artery Blood Flow

Unknown status·KKasr El Aini Hospital·Phase 4·NCT02978976·126 enrolled

Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?

Completed·—··NCT05640596·363 enrolled

Repeat Antenatal Steroids Trial

Terminated·TThe George Washington University Biostatistics Center·Phase 3·NCT00015002·486 enrolled

Dexamethasone2 trials

Epidural Dexamethasone Versus Betamethasone for Treatment of Lumbosacral Radiculalgia

Unknown status·BBasque Health Service·Phase 4·NCT02833116·320 enrolled

India Dexamethasone and Betamethasone

Completed·—·Phase 1·NCT03668860·48 enrolled

Effectiveness2 trials

Effectiveness of Cortisone Injection and Splinting for Trigger Finger

Unknown status·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 4·NCT03156829·120 enrolled

Effectiveness of ACS in Extreme Preemies

Withdrawn·PPediatrix·Phase 3·NCT02351310

Complication2 trials

Betamethasone and Complications of Lower Third Molar Surgery

Terminated·SShehab Ahmed Hamad·Phase 3·NCT07297264·40 enrolled

Dose Reduction of Antenatal Betamethasone Given to Prevent the Neonatal Complications Associated With Very Preterm Birth

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT02897076·3,250 enrolled

Treatment2 trials

Acute Unilateral Vestibulopathy and Corticosteroid Treatment

Terminated·LLund University·Phase 4·NCT02912182·78 enrolled

Steroid Treatment for Meatal Stenosis

Completed·SSehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital··NCT06834698·32 enrolled

35 more indications

Antenatal Corticosteroids2 trials

Single Dose Antenatal Corticosteroids (SNACS) for Women at Risk of Preterm Birth

Completed·MMcMaster University·Phase 3·NCT04494529·30 enrolled

Effect of Antenatal Corticosteroids in Late Preterm

Unknown status·MMeir Medical Center·Phase 2·NCT01710384·200 enrolled

Atopic Dermatitis2 trials

Safety and Efficacy of DNK333 in Atopic Dermatitis Patients

Completed· Novartis logo

Novartis·Phase 2·NCT01033097·80 enrolled

Efficacy and Safety of Fucicort® Lipid Cream Compared to Combination Treatment With Fucidin® Cream Followed by Betamethasone (Lianbang Beisong®) Cream and Fucicort® Lipid Cream Vehicle in Clinically Infected Atopic Dermatitis/Eczema

Terminated· LEO Pharma logo

LEO Pharma·Phase 3·NCT03395132·68 enrolled

Efficacy2 trials

Persistent Post-Lumbar Surgery Pain Syndrome (PSPS) Type II is a Common Condition Encountered in Pain Units, With Limited Available Therapeutic Options. Epidural Pulsed Radiofrequency (PRF) Administered Via Catheter Has Demonstrated Greater Efficacy Compared to the Transforaminal Approach. This Rand

Completed·PPuerta de Hierro University Hospital·N/A·NCT07156513·131 enrolled

Efficacy of Antenatal Steroids in Reducing Respiratory Morbidities in Late Preterm Infants

Unknown status·—·Phase 2·NCT01206946·700 enrolled

Phimosis1 trial

Mild Versus Potent Corticosteroids as Treatment for Phimosis in Children

Withdrawn·CChelsea and Westminster NHS Foundation Trust·Phase 4·NCT00933023

Randomized1 trial

Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial

Completed·TThe George Washington University Biostatistics Center·Phase 3·NCT01222247·2,831 enrolled

Alopecia Areata1 trial

To Compare the Efficacy of Weekly Azathioprine Pulse Versus Betamethasone Oral Mini-Pulse in the Treatment of Moderate to Severe Alopecia Areata

Completed·SSheikh Zayed Medical College·Phase 2·NCT06786689·60 enrolled

HCV Infection1 trial

Off-Label Use of Ribavirin in Management of Mucocutaneous Extrahepatic Manifestations of HCV Infection

Unknown status·TTanta University·N/A·NCT02261662·30 enrolled

Surgical1 trial

Comparison of Effect of Postoperative Cyclosporine A 2% Ophthalmic Emulsion and Betamethasone Eye Drop on Surgical Success of Trabeculectomy Procedure

Completed·MMashhad University of Medical Sciences·Phase 2·NCT02114073·40 enrolled

Glucocorticoid1 trial

A Study of Markers of Glucocorticoid Effects in Patients With Addisons Disease (DOSCORT)

Completed·GGöteborg University·Phase 4·NCT03210545·30 enrolled

Nausea and vomiting1 trial

Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery

Completed·HHôpital Privé de Parly II - Le Chesnay·Phase 3·NCT02744495·502 enrolled

Cesarean Section1 trial

Antepartum Betamethasone Treatment for Prevention of Respiratory Distress in Infants Born by Elective Cesarean Section

Terminated·EEmory University·Phase 2/3·NCT00139256·67 enrolled

Psoriasis1 trial

Safety, Tolerability And Efficacy Study Of Topical PF-06763809 In Subjects With Mild To Moderate Chronic Plaque Psoriasis

Completed· Pfizer logo

Pfizer·Phase 1·NCT03469336·18 enrolled

Pregnant Women1 trial

Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women With Threatened Premature Delivery

Completed·NNational Center for Research Resources (NCRR)·Phase 3·NCT00004778·1,090 enrolled

Pulmonary Function1 trial

Rescue Antenatal Steroids and Pulmonary Function Tests in Preterm Infants

Completed·OOregon Health and Science University·N/A·NCT00669383·85 enrolled

Efficacy and Safety1 trial

Evaluation of Efficacy and Safety of Epidural Steroid Injection Using Dexamethasone or Betamethasone

Completed·SSeoul National University Bundang Hospital·N/A·NCT01885481·600 enrolled

Tenosynovitis1 trial

Betamethasone Versus Ketorolac Injection for the Treatment of DeQuervains Tenosynovitis

Completed·OOrthoCarolina Research Institute, Inc.·Phase 4·NCT02604537·64 enrolled

Stem Cell Transplantation1 trial

Corneal Epithelium Repair and Therapy Using Autologous Limbal Stem Cell Transplantation

Unknown status·SSun Yat-sen University·Phase 1/2·NCT02148016·30 enrolled

Polymyalgia Rheumatica1 trial

Efficacy of Micro-Pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica

Unknown status·—·N/A·NCT00982332·20 enrolled

Pre-Term1 trial

Antenatal Corticoid Therapy for Late Preterm Babies

Completed·IInstituto Materno Infantil Prof. Fernando Figueira·N/A·NCT00675246·320 enrolled

Bronchiolitis1 trial

Nebulized Adrenalin and Oral Betamethasone in Children With Bronchiolitis Attending Pediatric Emergencies.

Terminated·AAssistance Publique - Hôpitaux de Paris·Phase 2/3·NCT02586961·195 enrolled

Sore Throat1 trial

Effect of Betamethasone Gel and Lidocaine Jelly on Sore Throat, Cough and Hoarseness of

Completed·TTehran University of Medical Sciences·Phase 3·NCT02114021·99 enrolled

Carpal Tunnel Syndrome1 trial

Sonography-guided Steroid Injection for Carpal Tunnel Syndrome

Completed·—·Phase 3·NCT02575729·39 enrolled

Greater Trochanteric Pain Syndrome1 trial

Comparison of Ozone and Steroid Injection in Patients With Greater Trochanteric Pain Syndrome

Completed·SSultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey·N/A·NCT04420572·63 enrolled

Adenoma1 trial

Prenatal Steroids for Treatment of Congenital Cystic Adenomatoid Malformations (CCAM)

Terminated·UUniversity of California, San Francisco·Phase 1/2·NCT00670956·1 enrolled

Hypoglycemia1 trial

Antenatal Betamethasone and the Risk of Neonatal Hypoglycemia

Unknown status·RRambam Health Care Campus··NCT03702959·1,000 enrolled

Ketorolac1 trial

Comparing Intra-articular Corticosteroid to Intra-articular Ketorolac Knee Injections

Unknown status·SSt. Luke's Hospital, Pennsylvania·Phase 4·NCT02612272·448 enrolled

Arthritis1 trial

Prolotherapy Versus Steroids for Thumb Carpo-metacarpal Joint Arthritis

Terminated·MMayo Clinic·N/A·NCT00685880·2 enrolled

Allergic Rhinitis1 trial

Efficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428)

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00963573·100 enrolled

Psoriasis Vulgaris1 trial

LEO 90100 in the Treatment of Psoriasis Vulgaris

Completed· LEO Pharma logo

LEO Pharma·Phase 2·NCT01536938·303 enrolled

Ultrasound1 trial

Ultrasound-guided Injection for DeQuervain's

Terminated·MMedical College of Wisconsin·Phase 4·NCT02038634·16 enrolled

Rehabilitation1 trial

Evaluation of Diprospan Injection to the Knee on Rehabilitation of Patients After TKR of the Contralateral Knee

Completed·HHadassah Medical Organization·Phase 4·NCT00542139·50 enrolled

Hospitalized Patients1 trial

ACTH vs Betamethasone in Hospitalized Patients With Acute Gout

Unknown status·UUniversity of Patras·N/A·NCT04306653·60 enrolled

Trigger Finger1 trial

Comparison of Ultrasound-Guided Betamethasone and Dextrose Injections in the Treatment of Trigger Finger: A Randomized Controlled Trial

Not yet recruiting·IIstanbul University - Cerrahpasa·Preclinical·NCT07681804·42 enrolled

PPROM1 trial

Does a Repeat Course of Antenatal Corticosteroids in Pregnant Women With Preterm Premature Rupture of Membranes Decrease Neonatal Morbidity?

Terminated·TThe University of Texas Medical Branch, Galveston·Preclinical·NCT02939742·33 enrolled

Unspecified4 trials

Amnion-Based Injections in the Shoulder

Withdrawn·UUniversity of Alabama at Birmingham·N/A·NCT03770546

Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections

Completed·WWest Virginia University·Phase 4·NCT04900220·66 enrolled

Can Betamethasone Given After Birth Help Extremely Premature Babies Come Off Breathing Support Safely and Effectively?

Not yet recruiting·KKhang Nguyen·Phase 2·NCT07447739·100 enrolled

Show 1 more trial

Caesarean and Corticotherapy

Completed·UUniversity Hospital, Strasbourg, France·Phase 4·NCT00446953·200 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

UTICORT

NDA NDA018089

Jan 1, 1982

UTICORT

NDA NDA017528

Jan 1, 1982

VALISONE

NDA NDA016932

Jan 1, 1982

VALISONE

NDA NDA016740

Jan 1, 1982

CELESTONE

NDA NDA014215

Jan 1, 1982

CELESTONE

NDA NDA014762

Jan 1, 1982

UTICORT

NDA NDA016998

Jan 1, 1982

VALISONE

NDA NDA016322

Jan 1, 1982

CELESTONE

NDA NDA017561

Jan 1, 1982

UTICORT

NDA NDA017244

Jan 1, 1982

CELESTONE

NDA NDA012657

Mar 24, 1983

BETA-VAL

NDA NDA018642

Jun 30, 1983

BETADERM

NDA NDA018839

Aug 31, 1983

BETAMETHASONE VALERATE

NDA NDA018866

Aug 31, 1983

BETAMETHASONE VALERATE

NDA NDA018861

Aug 31, 1983

BETAMETHASONE VALERATE

NDA NDA018860

Aug 31, 1983

BETATREX

NDA NDA018862

Aug 31, 1983

BETAMETHASONE VALERATE

NDA NDA018870

Aug 31, 1983

BETATREX

NDA NDA018867

Aug 31, 1983

BETAMETHASONE VALERATE

NDA NDA018865

Aug 31, 1983

BETAMETHASONE VALERATE

NDA NDA018864

Aug 31, 1983

BETATREX

NDA NDA018863

Feb 28, 1999

LUXIQ

NDA NDA020934

Sources

References

[1]
ClinicalTrials.gov — 52 trial records for Betamethasone. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Celestone drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Betamethasone compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Betamethasone. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020934). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Schering-Plough company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Glucocorticoid Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: SSchering-Plough

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