News|Articles|July 20, 2026

FDA Clears Consano’s IND for C-1101

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Key Takeaways

FDA IND clearance enables U.S. site activation for the ongoing Phase I C-1101-101 trial, with initial dosing already completed in Australia and near-term plans to begin treating U.S. patients.
C-1101 is a platelet-derived multi-protein biologic delivering standardized cytokines, growth factors, and matrix proteins via single epidural injection to achieve targeted exposure at the nerve injury site.
Conventional approaches largely provide transient analgesia or require invasive interventions; the development rationale emphasizes disease modification by addressing inflammatory and reparative biology at the nerve root.
C-1101-101 is a multicenter, randomized, controlled, double-blind dose-escalation study (n=24; three cohorts) prioritizing safety/tolerability, with exploratory pain, function, and sleep endpoints.
The clinical need is framed by high prevalence, substantial health-economic burden, and association with opioid initiation, underscoring demand for non-opioid pharmacologic alternatives.

FDA has cleared Consano Bio's IND for C-1101, a platelet-derived biologic delivered via single epidural injection, enabling U.S. expansion of a Phase I trial targeting chronic sciatica.

Consano Bio received FDA clearance of its investigational new drug application for C-1101, its lead therapy for chronic lumbosacral radiculopathy, commonly known as chronic sciatica.

The clearance authorizes expansion of Consano's Phase I clinical trial to U.S. sites, complementing the study already underway in Australia, where the first patient was dosed in May.^1,2

The company is expecting to begin dosing U.S. patients within the coming months.

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If fully approved, C-1101 would be the first FDA-approved pharmaceutical treatment for chronic sciatica, a condition that affects millions of people and currently has no approved drug therapy, despite being the leading cause of disability in the U.S. and costing the healthcare system an estimated $135 billion annually.¹ Lower back pain including lumbosacral radiculopathy is also the leading reason for opioid initiation, underscoring the urgency of developing non-opioid alternatives.

What is C-1101?

C-1101 is a novel, platelet-derived multi-protein biologic therapeutic designed to treat chronic sciatica by modulating inflammation and stimulating cellular repair at the site of nerve injury.¹ The product contains consistent concentrations of cytokines, growth factors and matrix proteins intended to trigger the body's natural healing response. It is delivered via a single epidural injection, providing targeted concentrations of these proteins directly to the injured nerve site.¹

The approach is distinct from conventional sciatica therapies, including pain medications, physical therapy, epidural steroid injections and implantable spinal cord stimulators, which primarily offer temporary symptom relief or require invasive surgical procedures rather than addressing the underlying biology of nerve root damage.¹ Consano describes C-1101 as a potential first-in-class, disease-modifying, non-opioid therapy.

What does the Phase I trial look like?

The Phase I study, designated C-1101-101, is a multi-center, randomized, controlled, double-blinded dose-escalation trial designed to enroll 24 patients across three sequential cohorts, with each participant receiving a single epidural injection.² Primary assessments focus on the safety and tolerability of C-1101, with additional measures evaluating changes in pain, physical function and sleep quality, key indicators of clinical improvement in chronic sciatica.² The first patient was dosed in Australia in May, and U.S. sites will now be added following the IND clearance.

Paul Verrills, lead investigator in Australia for the C-1101-101 study and founder of MetroPain in Melbourne, said the trial addresses a long-neglected patient population. "People living with chronic lumbosacral radiculopathy have limited treatment options and often struggle to find lasting relief," Verrills said. "This trial represents an important step toward identifying new approaches for a condition that has been underserved for far too long."

Andrew Hall, chief executive officer of Consano Bio, framed the IND clearance as validation of the program's scientific and manufacturing rigor. "From our founding in 2023, we have engaged the FDA continuously and constructively," Hall said. "IND clearance confirms that C-1101 meets the high scientific and manufacturing standards required to begin clinical development in the United States. C-1101 is a potential first-in-class, disease-modifying, non-opioid modality that targets the root biology of chronic sciatica, a condition affecting millions with no FDA-approved pharmaceutical treatment."

Sources

Consano Bio Receives FDA Investigational New Drug Clearance to Expand the C-1101 Chronic Sciatica Clinical Development Program into the United States Consano Bio July 20, 2026 https://www.prnewswire.com/news-releases/consano-bio-receives-fda-investigational-new-drug-clearance-to-expand-the-c-1101-chronic-sciatica-clinical-development-program-into-the-united-states-302828924.html
Consano Bio Initiates Phase 1 Clinical Trial of C-1101, a Potential First-in-Class, Non-Opioid Therapy for Chronic Sciatica Consano Bio May 26, 2026 https://www.prnewswire.com/news-releases/consano-bio-initiates-phase-1-clinical-trial-of-c-1101-a-potential-first-in-class-non-opioid-therapy-for-chronic-sciatica-302780849.html

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