Pipeline
One treatment, done properly
First-in-human trials starting August 2026.
Development programme
CBT005
CBT005 is a copy of a protein your body already makes. Injected into a worn disc, it switches the disc's own repair process back on.
Discovery
Preclinical
Phase I/II
IND
Phase III
Approval
GMP drug product manufactured
Clinical supply produced to the standard regulators require.
Favourable pre-IND meeting
The FDA confirmed BLA status, providing 12 years of extra protection beyond patents.
First-in-human trial activating
Running in Australia from August 2026.
Anticipated milestones
Development timeline
- August 2026 Trial activation First-in-human dosing.
- 2026–2028 Phase I/Phase II Dosing and 12-month follow-ups.
- 2027 IND filing Submission to the FDA.
- 2028–2031 Phase III Human trials in the United States.
- 2031–2032 FDA approval Regulatory review and decision.
- 2032 Market launch First commercial availability.
Dates are indicative. Each step depends on the results of the one before it.
Beyond the disc
Future indications
The same biology could apply elsewhere, giving CBT005 the potential to expand into further indications over time.
- Knee osteoarthritis
- Tendon regeneration
- Nerve healing
CBT005 is still being tested. It has not been approved for use in patients in any country.