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Brethine

(Terbutaline)

ApprovedSmall molecule

Terbutaline is used to treat asthma and chronic obstructive pulmonary disease (COPD) by relaxing the muscles in the airways to help you breathe easier. It can be used both to prevent symptoms and to treat sudden breathing problems.[2] Brethine is currently approved and in use across 13 indications[4].[1]

Brethine is one of 315 small molecule programs targeting Fatigue. It is currently in Approved.

13

Indications

22

Total Trials

1

Active Trials

314

Competitors

6

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Neuropathic PainActive, not recruiting

Status AsthmaticusActive, not recruiting

Airway ObstructionActive, not recruiting

Fetal DistressActive, not recruiting

Chronic Obstructive Pulmonary DiseaseApproved

HypoglycemiaActive, not recruiting

Heart FailureActive, not recruiting

Type 1 DiabetesActive, not recruiting

AsthmaActive, not recruiting

Immune ThrombocytopeniaActive, not recruiting

Neuropathic PainPhase 2

Active, not recruiting

Status AsthmaticusApproved

Active, not recruiting

Airway ObstructionApproved

Active, not recruiting

Fetal DistressPreclinical

Active, not recruiting

Chronic Obstructive Pulmonary DiseaseApproved

Approved

HypoglycemiaPreclinical

Active, not recruiting

Heart FailurePreclinical

Active, not recruiting

Type 1 DiabetesPhase 1

Active, not recruiting

AsthmaPhase 3

Active, not recruiting

Immune ThrombocytopeniaPhase 2

Active, not recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

1050 competitors in Asthma

#DrugCompanyPhaseTrials

Brethine

Xolair

Singulair

Cinqair

Formoterol Fumarate

Paracetamol

Blood Withdrawn

Emergent BioSolutions

Aclidinium Bromide

Lexapro

SShirley Ryan AbilityLab

Allergen Immunotherapy Extract

JJohns Hopkins University

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

Timeline

Expected Milestones

Q4 2026

Hot Flashes

NCT05193968

Clinical

Trials by Indication[1]

Asthma4 trials

Terbutaline Sulfate in Adults With Asthma

Withdrawn·KKanecia Obie Zimmerman·Phase 2/3·NCT04973345

Prn Budesonide/Formoterol Versus Regular Budesonide/Formoterol Plus Prn Terbutaline in Mild-Moderate Asthma

Completed·UUniversità degli Studi di Ferrara·Phase 3·NCT00849095·860 enrolled

Randomized Controlled Trial of Intravenous Magnesium Sulfate Versus Terbutaline for Children in the Management of Acute Exacerbation of Asthma

Completed·MMuhammad Aamir Latif·Phase 3·NCT06626620·120 enrolled

Show 1 more trial

Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00989833·66 enrolled

Immune Thrombocytopenia2 trials

The Combination of Terbutaline and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital·Phase 2·NCT04481282·40 enrolled

The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia

Unknown status·PPeking University People's Hospital·Phase 2·NCT05494307·228 enrolled

CLE2 trials

cAMP Signaling and Muscle Adaptations

Unknown status·UUniversity of Copenhagen·N/A·NCT02557581·72 enrolled

Beta2-adrenergic Agonism and Muscle Remodelling

Unknown status·MMorten Hostrup, PhD·N/A·NCT03565302·72 enrolled

Hot flashes1 trial

Hot Flashes and Neurovascular Function in Women

Recruiting·MMayo Clinic·N/A·NCT05193968·120 enrolled

Hypoglycemia1 trial

Use of Terbutaline or a Reduction in Basal Insulin in the Prevention of Nocturnal Hypoglycemia

Completed·UUniversity of Colorado, Denver·N/A·NCT00974051·16 enrolled

12 more indications

Fatigue1 trial

Role of K+ and Ca2+ in Development of Muscle Fatigue

Completed·UUniversity of Copenhagen·N/A·NCT02712658·10 enrolled

Type 1 Diabetes1 trial

A Pilot Study to Evaluate the Safety of Terbutaline in Children With Type 1 Diabetes

Completed·JJaeb Center for Health Research·Phase 1·NCT00607503·9 enrolled

Myelomeningocele1 trial

In Utero Repair of Myelomeningocele: Atosiban Versus Terbutaline

Completed·UUniversity of Sao Paulo General Hospital··NCT04468568·25 enrolled

Intravenous1 trial

Intravenous Terbutaline to Facilitate Labor Epidural Catheter Placement

Unknown status·KKai Schoenhage·Phase 4·NCT01651962·250 enrolled

Fetal distress1 trial

Acute Tocolysis With Terbutaline for Suspected Fetal Distress

Completed·HHospital Kemaman·N/A·NCT05326269·100 enrolled

ART1 trial

Nitroglycerin Versus Terbutaline for Intrapartum Fetal Resuscitation

Completed·SStanford University·N/A·NCT00185887·110 enrolled

Neuropathic Pain1 trial

Analgesic Effect of Beta 2-mimetics in the Treatment of Neuropathic Pain

Terminated·UUniversity Hospital, Strasbourg, France·Phase 2·NCT01582646·20 enrolled

Side Effects1 trial

Study to Evaluate is ECV Success is Improved and the Side Effects Reduced With the Use of IV NTGL Versus Terbutaline

Terminated·YYaakov Beilin·Phase 2/3·NCT02115256·6 enrolled

Heart Failure1 trial

Pharmacodynamic Study of Carvedilol Versus Metoprolol in Heart Failure

Completed·UUniversity of Utah·Phase 4·NCT00802230·25 enrolled

ESS1 trial

Success of External Cephalic Version Study

Terminated·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT03106753·34 enrolled

Status Asthmaticus1 trial

Trial of Terbutaline for the Treatment of Status Asthmaticus in Children

Completed·—·Phase 4·NCT00124995·40 enrolled

Unspecified1 trial

SHARE - Symbicort and Health Economics in a Real Life Evaluation

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00259766·1,970 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

BRETHINE

NDA NDA018571

Jan 1, 1982

BRICANYL

NDA NDA017466

Jan 1, 1982

BRETHINE

NDA NDA017849

Jan 1, 1982

BRICANYL

NDA NDA017618

Aug 17, 1984

BRETHAIRE

NDA NDA018762

Mar 19, 1985

BRICANYL

NDA NDA018000

Sources

References

[1]
ClinicalTrials.gov — 22 trial records for Terbutaline. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Brethine drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Terbutaline compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Terbutaline. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA018000). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Sanofi company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Beta-2 Adrenergic Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Sanofi

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