Celestone

(Betamethasone)

ApprovedSmall molecule

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 31 indications[4].[1]

Celestone is one of 312 small molecule programs targeting Premature Birth. It is currently in Approved.

Indications

Total Trials

Active Trials

311

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Premature BirthApproved

Polymyalgia RheumaticaActive, not recruiting

Oral Lichen PlanusApproved

ArthritisActive, not recruiting

Atopic EczemaApproved

TenosynovitisActive, not recruiting

HemorrhoidActive, not recruiting

Stenosing TenosynovitisActive, not recruiting

GlaucomaApproved

Airway ObstructionActive, not recruiting

Premature BirthApproved

Approved

Polymyalgia RheumaticaPreclinical

Active, not recruiting

Oral Lichen PlanusApproved

Approved

ArthritisPreclinical

Active, not recruiting

Atopic EczemaApproved

Approved

TenosynovitisApproved

Active, not recruiting

HemorrhoidApproved

Active, not recruiting

Stenosing TenosynovitisPreclinical

Active, not recruiting

GlaucomaApproved

Approved

Airway ObstructionApproved

Active, not recruiting

Showing 10 of 31 indications

Competition

Competitive Landscape

54 competitors in Glaucoma

#DrugCompanyPhaseTrials

Celestone

SSchering-Plough

Approved

55 2

Travatan

Novartis

Approved

3 3

Alphagan

Novartis

Approved

3 4

Zolymbus

AbbVie

Approved

3 5

Xalatan

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

Approved

10 6

Timolol Maleate

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

9 7

Diamox

Teva

Approved

1 8

Crestor

AstraZeneca

Approved

1 9

Neoral

Novartis

Approved

—10

Flovent

PParatek Pharmaceuticals Inc

Approved

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

Timeline

Expected Milestones

Q2 2027

PreclinicalRecruiting

Trigger Finger

NCT07681804

Q1 2028

PreclinicalNot yet recruiting

Thyroid Eye Disease

NCT07866261

Q1 2029

Phase 2Not yet recruiting

Study completion

NCT07447739

Clinical

Trials by Indication[1]

Steroid3 trials

Repeat Antenatal Steroids Trial

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

Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?

Completed·—··NCT05640596·363 enrolled

Effect of Antenatal Steroid on Pulmonary Artery Blood Flow

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

Antenatal Corticosteroids2 trials

Effect of Antenatal Corticosteroids in Late Preterm

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

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

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

Efficacy2 trials

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

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

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

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

38 more indications

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

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

Dexamethasone2 trials

India Dexamethasone and Betamethasone

Completed·—·Phase 1·NCT03668860·48 enrolled

Epidural Dexamethasone Versus Betamethasone for Treatment of Lumbosacral Radiculalgia

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

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

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

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

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

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

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

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

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

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

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

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

Carpal Tunnel Syndrome1 trial

Sonography-guided Steroid Injection for Carpal Tunnel Syndrome

Completed·—·Phase 3·NCT02575729·39 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

Not yet recruiting·AAssiut University·Preclinical·NCT07866261·54 enrolled

Trigger Finger1 trial

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

Recruiting·IIstanbul University - Cerrahpasa·Preclinical·NCT07681804·42 enrolled

Adhesive Capsulitis1 trial

Comparison of the Effectiveness of Ultrasound-Guided Pericapsular and Intra-Articular Steroid Injections in Patients Diagnosed With Adhesive Capsulitis

Completed·IIstanbul University - Cerrahpasa·Preclinical·NCT07710651·34 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

Differences in Flare Reaction Incidence and Intensity Following Trigger Finger Injections

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

Caesarean and Corticotherapy

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

Amnion-Based Injections in the Shoulder

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

Show 1 more trial

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

Regulatory

FDA Approval Timeline[5]

Mar 3, 1965

CELESTONE SOLUSPAN

NDA NDA014602

Aug 8, 1979

CELESTONE SOLUSPAN

NDA NDA014602

Jan 1, 1982

CELESTONE

NDA NDA012657

Jan 1, 1982

CELESTONE

NDA NDA014215

Jan 1, 1982

VALISONE

NDA NDA016740

Jan 1, 1982

UTICORT

NDA NDA018089

Jan 1, 1982

VALISONE

NDA NDA016932

Jan 1, 1982

UTICORT

NDA NDA017528

Jan 1, 1982

CELESTONE

NDA NDA017561

Jan 1, 1982

UTICORT

NDA NDA017244

Jan 1, 1982

VALISONE

NDA NDA016322

Jan 1, 1982

UTICORT

NDA NDA016998

Jan 1, 1982

CELESTONE

NDA NDA014762

Jun 30, 1982

CELESTONE SOLUSPAN

NDA NDA014602

Nov 4, 1982

CELESTONE SOLUSPAN

NDA NDA014602

Mar 24, 1983

BETA-VAL

NDA NDA018642

Jun 30, 1983

BETADERM

NDA NDA018839

Aug 31, 1983

BETATREX

NDA NDA018862

Aug 31, 1983

BETAMETHASONE VALERATE

NDA NDA018860

Aug 31, 1983

BETAMETHASONE VALERATE

NDA NDA018870

Aug 31, 1983

BETAMETHASONE VALERATE

NDA NDA018864

Aug 31, 1983

BETAMETHASONE VALERATE

NDA NDA018865

Aug 31, 1983

BETAMETHASONE VALERATE

NDA NDA018861

Aug 31, 1983

BETATREX

NDA NDA018863

Aug 31, 1983

BETATREX

NDA NDA018867

Aug 31, 1983

BETAMETHASONE VALERATE

NDA NDA018866

Jun 10, 1986

CELESTONE SOLUSPAN

NDA NDA014602

Jul 1, 1987

CELESTONE SOLUSPAN

NDA NDA014602

May 1, 1990

CELESTONE SOLUSPAN

NDA NDA014602

Feb 6, 1992

CELESTONE SOLUSPAN

NDA NDA014602

Dec 17, 1992

CELESTONE SOLUSPAN

NDA NDA014602

Sep 7, 1993

CELESTONE SOLUSPAN

NDA NDA014602

Mar 14, 1994

CELESTONE SOLUSPAN

NDA NDA014602

Apr 13, 1994

CELESTONE SOLUSPAN

NDA NDA014602

May 3, 1995

CELESTONE SOLUSPAN

NDA NDA014602

Nov 13, 1996

CELESTONE SOLUSPAN

NDA NDA014602

Jul 21, 1997

CELESTONE SOLUSPAN

NDA NDA014602

Feb 28, 1999

LUXIQ

NDA NDA020934

Jul 15, 1999

CELESTONE SOLUSPAN

NDA NDA014602

Oct 8, 1999

CELESTONE SOLUSPAN

NDA NDA014602

Apr 10, 2000

CELESTONE SOLUSPAN

NDA NDA014602

Jul 24, 2001

CELESTONE SOLUSPAN

NDA NDA014602

Jul 12, 2006

CELESTONE SOLUSPAN

NDA NDA014602

Jun 24, 2008

CELESTONE SOLUSPAN

NDA NDA014602

Jan 9, 2013

CELESTONE SOLUSPAN

NDA NDA014602

Mar 13, 2013

CELESTONE SOLUSPAN

NDA NDA014602

May 21, 2014

CELESTONE SOLUSPAN

NDA NDA014602

Jul 3, 2014

CELESTONE SOLUSPAN

NDA NDA014602

Feb 4, 2015

CELESTONE SOLUSPAN

NDA NDA014602

Feb 9, 2018

CELESTONE SOLUSPAN

NDA NDA014602

Apr 10, 2018

CELESTONE SOLUSPAN

NDA NDA014602

Sep 6, 2022

CELESTONE SOLUSPAN

NDA NDA014602

Jun 5, 2024

CELESTONE SOLUSPAN

NDA NDA014602

Jul 8, 2024

CELESTONE SOLUSPAN

NDA NDA014602

Sources

References

[1]
ClinicalTrials.gov — 55 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 NDA014602). 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

Celestone

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q1 2028

Q1 2029

Trials by Indication[1]

Steroid3 trials

Antenatal Corticosteroids2 trials

Efficacy2 trials

Effectiveness2 trials

Complication2 trials

Treatment2 trials

Atopic Dermatitis2 trials

Dexamethasone2 trials

Sore Throat1 trial

Randomized1 trial

HCV Infection1 trial

Alopecia Areata1 trial

Surgical1 trial

Glucocorticoid1 trial

Nausea and vomiting1 trial

Psoriasis1 trial

Psoriasis Vulgaris1 trial

Ultrasound1 trial

Rehabilitation1 trial

Hospitalized Patients1 trial

Pregnant Women1 trial

Pulmonary Function1 trial

Efficacy and Safety1 trial

Tenosynovitis1 trial

Stem Cell Transplantation1 trial

Adenoma1 trial

Hypoglycemia1 trial

Ketorolac1 trial

Arthritis1 trial

Polymyalgia Rheumatica1 trial

Pre-Term1 trial

Bronchiolitis1 trial

Greater Trochanteric Pain Syndrome1 trial

Allergic Rhinitis1 trial

Carpal Tunnel Syndrome1 trial

Cesarean Section1 trial

Phimosis1 trial

Knee Osteoarthritis1 trial

Thyroid Eye Disease1 trial

Trigger Finger1 trial

Adhesive Capsulitis1 trial

PPROM1 trial

Unspecified4 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Related News