New Chronic Sciatica Therapy Enters the US: FDA Clears Phase 1 Trial of C-1101

Chronic sciatica is often more than a passing bout of pain: discomfort extending from the lower back down the leg can persistently interfere with walking, sleep, and daily activities. The US Food and Drug Administration (FDA) has cleared Consano Bio’s investigational new drug application, allowing the company to expand its early-stage clinical program for C-1101 into the US. This decision means that US trial sites may join the study; it does not constitute confirmation of efficacy or approval for marketing.

C-1101 is a standardized, platelet-derived multi-protein biologic intended to treat chronic painful lumbosacral radiculopathy, commonly known as chronic sciatica, through a single transforaminal epidural injection. Unlike drugs that target a single molecule, this type of product contains multiple proteins, but currently available public data are insufficient to demonstrate that its composition can produce clinically meaningful pain relief.

The ongoing C-1101-101 trial, registered as NCT07264270, uses a randomized, double-blind, placebo-controlled, dose-escalation design and is expected to enroll 24 adults. Participants will receive a low, medium, or high dose of C-1101, or sterile saline as a control. The three dose groups will proceed sequentially, allowing the research team to review safety data before increasing exposure.

The primary question in this Phase 1 study is not “whether it can relieve pain,” but whether a single injection is safe and tolerable. The primary measures include adverse events occurring within 24 weeks after treatment, their severity, and safety events of special interest. Pain, physical function, and sleep quality are exploratory assessments; any signals observed will mainly be used to plan subsequent studies and cannot on their own be regarded as definitive evidence of efficacy.

The company said the first participant was dosed in Australia in May 2026 and that enrollment in the US is expected to begin within several months. The clinical trial registry, meanwhile, lists the study’s actual start date as December 3, 2025, with the primary assessment estimated to be completed in November 2026 and the overall study in December of the same year. The two date descriptions may refer respectively to administrative initiation and first dosing.

The practical significance of the FDA’s IND clearance is that the regulator is allowing the study to proceed in the US under the authorized protocol, not that it has determined the product to be safe and effective. With a sample of only 24 people and safety as its primary objective, even if exploratory measures show improvement, larger controlled trials with adequate statistical power will still be needed to determine whether the effect is reliable, how long it lasts, and which patients may benefit.