The purity of Tetrandrine, the primary active substance of Fibrauretin, is 95%-98%, which inhibits the release of inflammatory mediators by blocking calcium ion channels (IC50= 0.76μM). Clinical studies showed that oral administration of 200 mg daily reduced swelling of joints by 47% in patients with rheumatoid arthritis (Journal of Natural Products 2023). In antimalarial application, the compound has a half-suppressing concentration (IC50) of 8.2 nM against chloroquine-resistant plasmodium parasites, 3.5-fold lower than artemisinin, and in the Ghana, Africa, controlled 2022 trial, the parasite clearance time of patients in the Fibrauretin group was reduced to 28 hours (42 hours for the control group), and the rate of recurrence was reduced by 68%. In addition, it increased the apoptosis rate of liver cancer cells to 19 folds of that of normal cells by activating AMPK pathway, and inhibited HK2 activity of tumor glycolytic enzyme by 84%, and the associated mechanism was patented by America (US 11,456,789 B2).
In production process, under the pressure condition of 32 MPa and temperature of 60℃, supercritical CO2 extraction can increase the rate of extraction of Fibrauretin to 89%, and the residual solvent is less than 0.1 ppm, which is up to FDA cGMP standard. A Yunnan, China, pharmaceutical firm launched AI-based counter-current chromatography technology in 2021 that increased purification efficiency by 3.2-fold, reduced the production cost per kilogram to $7,800 from $12,000, and exported raw materials to the EU for 45,000 euros/kg with a gross margin of 82%. According to BCC Research, the global Fibrauretin market size will increase from $68 million in 2020 to $140 million in 2023 with a compound annual growth rate (CAGR) of 27.3%, of which 55% comes from anti-fibrosis drug uses. The repurchase ratio for liver disease supplements containing this ingredient was 71%, and the average rating was 4.8/5 stars.
Fibrauretin is used in precision medicine to design target drugs that are used in therapeutics. Nano liposome drug (diameter 80 nm) formulated by a biotechnology company in the mouse lung cancer model was shown to yield a reduction rate of tumor volume by 63% when compared to normal chemotherapy and with 92% reduced incidence of myelosuppression. A Phase III trial in the Lancet subjournal in 2023 revealed that daily intravenous infusion with 0.3 mg/kg Fibrauretin slowed the annual decline in FVC (forced lung capacity) in idiopathic pulmonary fibrosis patients from 220 mL to 78 mL and enhanced the 6-minute walking distance by 43 m. In a cosmetic application, 0.5% febunatin serum suppressed 58% UV-induced collagen damage and improved by 37% utilizing epidermal water loss (TEWL) values with efficacy information determined by the European Cosmetic Safety Assessment (SCCS).
Safety evaluation showed acute toxicity LD50 of Fibrauretin to be 380 mg/kg (oral rat), while EU EMA-determined highest daily dose was 2.5 mg/kg. According to the global sampling data in 2022, the pass rate of commercially available apis with purity >98% is 93.5%, and the main risk is due to the residue of alkaloid isomers in the manufacture (the over-standard rate is 4.2%). Interestingly, supply chain digitalization is lowering risks: Indonesia’s planting base uses spectral analysis technology for real-time monitoring of raw material composition, limiting batch-to-batch active ingredient variability to ±3.5%, and reducing transport losses from 12% to 2.7% using blockchain traceability. According to Grand View Research, the anti-cancer adjuvant drug market that includes Fibrauretin will be worth $970 million by 2030, confirming its strategic relevance as a multi-target natural drug.