Rifabutin (LM427) Clinical Trials

Size	Price	Qty
25mg	USD 147
100mg	USD 247

Clinical Trials

Several clinical trials evaluate rifabutin across Phase 1 and Phase 3 development, comprising both actively recruiting and completed studies sponsored by entities like BioVersys AG and Tourcoing Hospital. These trials assess healthy participants along with conditions such as bacterial infections, staphylococcal prosthetic infections, and renal impairment. Phase 1 research evaluates safety, pharmacokinetics, and pulmonary tissue penetration, whereas Phase 3 research examines therapeutic efficacy in implant-related infections.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05684705	Recruiting	Bacterial Infections	BioVersys AG\|CW-Research and Management GmbH	2023-09-01	Phase 1
NCT05684718	Completed	Bacterial Infections	BioVersys AG\|CRU Hungary Kft	2023-02-01	Phase 1
NCT05537142	Recruiting	Healthy Participants	BioVersys AG\|CRU Hungary Kft	2022-09-02	Phase 1
NCT04672525	Recruiting	Prosthetic Infection	Tourcoing Hospital	2021-11-08	Phase 3
NCT05086107	Completed	Renal Impairment	BioVersys AG\|CRU Hungary Kft\|CRU Hungary Early Phase Unit	2021-10-08	Phase 1

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

Check the Rifabutin (LM427) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rifabutin binds to bacterial DNA-dependent RNA polymerase, thereby blocking the initiation of RNA transcription and inhibiting essential microbial RNA synthesis. This cellular suppression halts bacterial proliferation, providing therapeutic utility against complex bacterial infections and prosthetic joint infections evaluated in clinical trials.

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>).