Clinical Trials

Numerous clinical trials evaluate terbutaline across Early Phase 1 through Phase 4, primarily targeting respiratory conditions like asthma and obstetric applications such as labor induction, labor pain, and fetal distress, as well as renal colic and type 1 diabetes. Supported by both academic sponsors, including the Icahn School of Medicine at Mount Sinai and the University of Arizona, and corporate entities like AstraZeneca, these investigations span completed, actively recruiting, and not yet recruiting protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06980727 NOT_YET_RECRUITING
Renal Colic
University of Monastir
 2026-08-08 PHASE3
NCT05193968 RECRUITING
Hot Flashes; Menopause; Vasomotor System; Labile
Mayo Clinic
 2022-02-24
NCT04973345 WITHDRAWN
Asthma
Kanecia Obie Zimmerman
 2023-07-07 PHASE2; PHASE3
NCT06626620 COMPLETED
Acute Exacerbation of Asthma
Muhammad Aamir Latif
 2024-01-01 PHASE3
NCT06199154 Not yet recruiting
Morbid Obesity|Pregnancy
University of Maryland Baltimore
 2024-05 Early Phase 1
NCT05494307 UNKNOWN
Immune Thrombocytopenia
Peking University People's Hospital
 2022-09-01 PHASE2
NCT05873218 Recruiting
Labor
Icahn School of Medicine at Mount Sinai
 2023-06-26 Phase 4
NCT04705727 TERMINATED
Asthma in Children
Centre Hospitalier Intercommunal Creteil
 2021-08-23 PHASE3
NCT03565302 UNKNOWN
Hypertrophy; Physiologic Hypertrophy; Physical Activity
Morten Hostrup, PhD
 2018-06-25
NCT04481282 UNKNOWN
Immune Thrombocytopenia
Peking University People's Hospital
 2020-07-08 PHASE2
NCT05326269 COMPLETED
Nonreassuring Fetal Status
Hospital Kemaman
 2017-04-23
NCT03976037 Completed
Induction of Labor
Christiana Care Health Services
 2019-06-04 Early Phase 1
NCT03106753 TERMINATED
External Cephalic Version
Icahn School of Medicine at Mount Sinai
 2017-04-12 PHASE4
NCT01582646 TERMINATED
Postthoracotomy Pain; Postthoracoscopy Neuropathic Pain
University Hospital, Strasbourg, France
 2012-01 PHASE2
NCT02224157 COMPLETED
Asthma
AstraZeneca
 2014-11-28 PHASE3
NCT02149199 COMPLETED
Asthma
AstraZeneca
 2014-07-07 PHASE3
NCT02557581 UNKNOWN
Muscle Hypertrophy in Healthy Young Men
University of Copenhagen
 2015-07
NCT03140488 Completed
Obesity|Labor Induced|Oxytocin
University of Arizona
 2017-06-05 Phase 4
NCT02712658 COMPLETED
Skeletal Muscle Fatigue in Humans
University of Copenhagen
 2015-09
NCT02322788 COMPLETED
Asthma
AstraZeneca
 2015-03 PHASE3
NCT01651962 UNKNOWN
Labor Pain
Kai Schoenhage
 2012-08 PHASE4
NCT02115256 TERMINATED
External Cephalic Version
Yaakov Beilin
 2014-07 PHASE2; PHASE3
NCT02178059 COMPLETED
Healthy Volunteers
AstraZeneca
 2014-08 PHASE1
NCT00849095 COMPLETED
Asthma
Università degli Studi di Ferrara
 2009-04 PHASE3
NCT00839800 COMPLETED
Asthma
AstraZeneca
 2009-02 PHASE3
NCT00989833 COMPLETED
Exercise Induced Asthma
AstraZeneca
 2009-09 PHASE2
NCT01096017 COMPLETED
Asthma
AstraZeneca
 2010-03 PHASE3
NCT00914797 UNKNOWN
Asthma
Bispebjerg Hospital
 2009-07 PHASE4
NCT00837967 COMPLETED
Asthma
AstraZeneca
 2009-01 PHASE3
NCT00974051 COMPLETED
Type 1 Diabetes
University of Colorado, Denver
 2008-03
NCT00607503 COMPLETED
Type 1 Diabetes
Jaeb Center for Health Research
 2008-02 PHASE1
NCT00124995 COMPLETED
Status Asthmaticus
Connecticut Children's Medical Center
 2003-10 PHASE4
NCT00185887 COMPLETED
Fetal Distress
Stanford University
 2003-10
NCT00802230 COMPLETED
Heart Failure
University of Utah
 2002-09 PHASE4
NCT00259766 COMPLETED
Asthma
AstraZeneca
 2004-04 PHASE3
NCT00214318 COMPLETED
Heart Failure
University of Wisconsin, Madison
 2005-01
NCT00326053 COMPLETED
Asthma
AstraZeneca
 2006-05 PHASE3
NCT00252863 COMPLETED
Asthma
AstraZeneca
 2004-12 PHASE3
NCT00244608 COMPLETED
Asthma
AstraZeneca
 2005-05 PHASE3
NCT00421122 COMPLETED
Chronic Obstructive Pulmonary Disease
AstraZeneca
 2006-09 PHASE3
NCT00242775 COMPLETED
Asthma
AstraZeneca
 2005-05 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-07-15)

Check the Terbutaline Sulfate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Terbutaline sulfate selectively binds to and activates β2-adrenergic receptors with an IC50 of 53 nM, stimulating Gs protein-coupled adenylate cyclase to elevate intracellular cyclic AMP levels and reduce intracellular calcium concentration. This molecular cascade induces smooth muscle relaxation in bronchial passages and the myometrium, providing therapeutic relief in airway constriction associated with asthma as well as modulating uterine contractions during labor.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.