Betulin Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 490

Clinical Trials

Sponsored by Birken AG and Amryt Pharma, a completed Phase 3 clinical trial evaluated the clinical efficacy and safety of a betulin-based topical treatment in patients suffering from burn injuries. This prospective, controlled study analyzed intra-individual treatment responses to establish the compound's therapeutic potential in tissue repair and burn care management. Overall, the clinical trial landscape for betulin reflects targeted late-stage investigation specifically directed at dermatological recovery following thermal injury.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01657292	Completed	Burns	Birken AG\|Amryt Pharma	2012-08	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Betulin functions as an inhibitor of sterol regulatory element-binding proteins (SREBP), disrupting the maturation of SREBP precursors and suppressing downstream lipid and cholesterol biosynthetic gene expression. By suppressing SREBP-mediated metabolic pathways and modulating cellular lipid homeostasis, betulin mitigates inflammatory responses and promotes cellular repair mechanisms, which underlies its therapeutic utility in burn wound management.

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>).