Second FDA Response Letter Issued for ND0612 Therapy

An under-the-skin infusion of levodopa and carbidopa, called ND0612, has received a second Complete Response Letter from the U.S. Food and Drug Administration (FDA). A Complete Response Letter is a notice that outlines issues with safety, efficacy or manufacturing that need to be resolved before the treatment can be approved.

ND0612 was first submitted to the FDA in 2023 as a potential new treatment to help manage motor fluctuations (periods when movement symptoms improve as medication works and then return as it wears off) in people with Parkinson's disease. In June 2024, the FDA sent a first Complete Response Letter asking for additional information before reconsidering approval.

In response, the company gathered more data on the safety of one of ND0612's drug components, as well as additional details about product quality, device and manufacturing site inspections. The company resubmitted the applicationin May 2025. After reviewing the updated submission, the FDA issued a second Complete Response Letterin October 2025, suggesting that further questions still need to be addressed.

ND0612 delivers a combination of levodopaand carbidopa in liquid form under the skin through a wearable pump and infusion set, helping to reduce motor symptom fluctuations in people with Parkinson's disease. Levodopa is a drug that is converted into dopamine in the brain, and carbidopa is a drug that helps stop levodopa from breaking down so it can last longer in the body.

Delivering medication under the skin rather than through the digestive system bypasses the stomach, potentially helping maintain steady drug levels and therefore steadier symptom control. ND0612 is one of several infusion systems that have been considered for FDA approval in the past several years.

ND0612 was developed with support from The Michael J. Fox Foundation as part of our de-risking strategy, which provides early funding to promising therapeutics to strengthen the treatment pipeline. This early developmental supporthelped demonstrate that ND0612 was safe and well tolerated, reduced medication "off" timeand improved Parkinson's disease symptomsand quality of life.

Receiving a Complete Response Letters is part of the FDA review processand does not necessarily indicate that a therapy will not be approved. MJFF will continue to closely monitor the progress of this therapy.

• Claire Cole

  Director of Research Communications