Formoterol Hemifumarate Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

Several clinical trials evaluate Formoterol Hemifumarate therapies for respiratory conditions, primarily asthma and chronic obstructive pulmonary disease (COPD). Sponsored by major industry partners such as Sanofi and Orion Corporation Orion Pharma, these studies encompass Phase 2 dose-ranging trials as well as non-phased observational evaluations. Across these investigations, recruitment statuses span actively recruiting, active not recruiting, and terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06102005	Recruiting	Asthma	Sanofi	2023-10-16	Phase 2
NCT05421598	Active not recruiting	Asthma	Sanofi	2022-06-30	Phase 2
NCT04663386	Terminated	Asthma\|COPD	Orion Corporation Orion Pharma	2020-12-10	--

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Formoterol hemifumarate selectively binds to and activates β2-adrenergic receptors with high affinity, triggering intracellular cAMP production to induce smooth muscle relaxation in bronchial tissues. This potent bronchodilatory action directly reduces airway resistance, offering significant therapeutic benefit in managing exacerbations and improving airflow in clinical conditions such as asthma and chronic obstructive pulmonary disease.

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>).