PHARMACEUTICALS

Our portfolio of sublingual pharmaceutical products is built on the WaferiX platform technology, and includes pipeline products in the late stage of development

No.
Active
Therapeutic Areas
Clinical Studies
Pharmaceuticals
Pre Clinical
P1
P2
P3
Marketing Approval
1
Wafesil
Urology
2
Wafermine
Central Nervous System
3
iXB 401
Metabolic Disorders, Endocrinology
4
NAD+
Neurology, Musculoskeletal Health
5
iXB 120
Central Nervous System
6
iXB 321
Immunology and Infectious Disease
7
iXB 322
Immunology and Infectious Disease

Wafermine

World’s first sublingual ketamine for acute moderate to severe pain.

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:

  • Strong analgesic effect
  • Safe and tolerable
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iXB 401

Sublingual semaglutide wafers for the treatment of diabetes and obesity

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

Dexmedetomidine

Sublingual dexmedetomidine wafer for the treatment of acute agitation in dementia.

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.

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Bnox

Improved bioavailability from other sublingual buprenorphine products.

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.

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Wafesil & Silcap

Sildenafil for the treatment of erectile dysfunction in unique dosage forms.

Wafesil (Sildenafil Citrate) Sublingual Wafers
ARTG 288496, 288497

➤ Product Information

➤ Consumer Medicine Information

Silcap (Sildenafil Citrate) Oral Capsules
ARTG 291996, 291997

➤ Product Information

➤ Consumer Medicine Information

Scientific Publications

Disclaimer when entering iX Biopharma’s Pharmaceutical page:
This website is iX Biopharma Ltd’s global website, intended for visitors worldwide. Please note that this page is in no way intended to promote in any way, any use, either approved or unapproved, registered or unregistered of an iX Biopharma Ltd’s product in Australia. As the registration conditions differ internationally, please note that not all products listed on our website are approved or registered or authorised for sale or use by the Australian Government Therapeutic Goods Administration (TGA). By assessing this page, you have agreed and understood this.
Disclaimer when entering iX Biopharma’s site:
This website is iX Biopharma Ltd’s global website, intended for visitors worldwide. Please note that this website is in no way intended to promote in any way, any use, either approved or unapproved, registered or unregistered of an iX Biopharma Ltd’s product in Australia. As the registration conditions differ internationally, please note that not all products listed on our website are approved or registered or authorised for sale or use by the Australian Government Therapeutic Goods Administration (TGA). By assessing this website, you have agreed and understood this.