Our portfolio of sublingual pharmaceutical products is built on the WaferiX platform technology, and includes pipeline products in the late stage of development
Phase 3-ready for acute pain, Phase 2-ready for Complex Regional Pain Syndrome and Depression
Non-opioid with opioid sparing effects
Positive in Phase 2b clinical studies:
Formulated with WaferlogiX to address poor oral bioavailability of Semaglutide (~1%), by adding sublingual absorption to improve bioavailability and lower variability of absorption.
Preclinical studies in mice and rats show significantly improved absorption of Semaglutide compared to Rybelsus
Completed Phase 1 Sublingual Dexmedetomidine Clinical Study
The Phase 1 pharmacokinetic clinical study achieved several positive results:
1. High bioavailability: The sublingual wafer showed an impressive 70-80% absolute bioavailability across all dosages tested.
2. Fast onset of action: The sublingual wafer achieved a peak drug concentration in 1.5 hours (Tmax), with drug detectable in plasma as early as 5 minutes post dosing.
3. Dose proportional: The drug exposure was proportional across the dosing range.
4. Safety profile: Sublingual wafers were safe and well tolerated; there were no serious adverse events.
By utilising iX Biopharma’s proprietary sublingual technology WaferiX, we have demonstrated in a phase 1 pharmacokinetic study (BUP001) that BnoX facilitates the rapid absorption of buprenorphine (median Tmax 1.0 hour) with greater absolute bioavailability of 45%. These results suggest superior pharmacokinetics to currently marketed sublingual buprenorphine formulations.
LEARN MORESildenafil citrate has been shown to be a hallmark drug for the treatment of erectile dysfunction in males. Utilising WaferiX, Wafesil is a sildenafil wafer that is administered sublingually. Wafesil comes in a new dosage form and route of administration for patients who cannot or prefer not to swallow. Wafesil is approved for marketing in Australia, outlicensed for China market.
Silcap is a novel small sildenafil capsule that is easy to swallow. Silcap is approved for marketing in Australia and Singapore.