‘Blockbuster’ one-shot low back pain drug in the home stretch of final test
By Bronwyn Thompson
August 19, 2026
Earlier results show this novel therapy could offer 12 months of pain relief
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Earlier results show this novel therapy could offer 12 months of pain relief
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A highly anticipated drug trial is in its final stages as its 350 participants receive their single dose to treat chronic low back pain. If successful, the experimental medication could be a breakthrough therapeutic for people with the common but debilitating condition
This week, Australian biotechnology company Mesolab announced that its Phase 3 trial of rexlemestrocel-L for chronic low back pain (CLBP) now moves beyond the patient-treatment stage
The trial was originally set to test the drug on 300 people, but due to demand from trial investigators to include more of their patients, the researchers expanded the pool of participants to 350
Half received the active therapeutic a “sham” (control) shot. The goal is for those who received the active dose to see a marked, long-term reduction in pain. As such, the study’s primary endpoint will assess how participants feel after 12 months
While the main goal is key, secondary endpoints <a href="https://healthylife7.com/what-must-remain-possible-for-africa-to-flourish/” title=”What must remain possible for Africa to flourish?”>remain important. These include improved physical function and quality of life and discontinuation of pain medications for the condition
“Completing treatment of 350 patients in our pivotal low back pain trial is a momentous milestone for the company as we now count down to the 12-month read-out for what we hope will be the basis of our first blockbuster product,” Mesoblast’s chief executive Silviu Itescu said in a statement
Derived from human bone marrow, rexlemestrocel-L was designed to be an off-the-shelf, targeted injection to regenerate worn spinal discs. When the discs degenerate, vertebrae lose the spongy buffer between bones, resulting in pain
This new stromal cell injection shifts the focus from traditional pain management to regenerative treatment. Rebuilding the buffers between joints is something we’ve covered for years, so it’s not hard to see why this trial is being watched closely
Those enrolled have experienced CLBP due to degenerative disc disease (DDD) for less than five years
The condition is also the leading cause of back pain. Estimates suggest that around 20% of US adults show disc degeneration by age 65. A novel treatment that could rebuild, or at the very least bolster, degraded discs could be life-changing for millions of people
Rexlemestrocel-L is also being developed for the treatment of heart failure, and has shown promising results so far. The drug currently has Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for CLBP treatment – which essentially means that, if this Phase 3 study meets its goals, it can be prioritized for approval
We’ll know if it’s been successful by mid-2027, when all participants have had their 12-month evaluation
Fact-checked by Mike McRae
