Phase I Clinical Trials for Development of Neurotherapeutics

The National Institute of Neurological Diseases and Stroke (NINDS), National Institutes of Health (NIH) awarded a Master IDIQ for full-service Phase I clinical trial operations supporting the development of novel neurotherapeutic agents, with ordering closed as of June 30, 2026. The vehicle is no longer available for new task-order placement. The IDIQ was established July 1, 2016 and operated for a full ten-year ordering period with a shared ceiling of $19.5 million.

Ten task orders were awarded under the vehicle, with only two distinct primes capturing all awards and combined potential value. PPD Development LP dominates with 7 orders valued at $18 million combined potential, while Duke University holds 3 orders valued at $4 million. Combined task-order potential value across all ten orders reached $22 million, with $13.1 million obligated (60% of combined potential value). Recent ordering momentum declined significantly—only one order was placed in 2026, one in 2024, and one in 2021, compared to two orders in each of 2018 and 2019.

Scope spans Phase I development across multiple neurotherapeutic mechanisms: single ascending dose and multiple ascending dose studies dominate the task-order portfolio, with recent work including studies of DTI-117, CSF bioavailability assessments, and protocol development paired with database and bioanalytical methods development. Task orders reflect cost-plus fixed-fee and cost-no-fee arrangements typical of clinical trial execution, with ceiling values ranging from approximately $409 thousand to $5.1 million and durations extending one to four years.

Customer concentration is moderate: NINDS placed 5 orders valued at $11.4 million combined potential (50% of vehicle activity); the National Institute on Drug Abuse placed 3 orders valued at $7 million (32%); and the National Center for Advancing Translational Sciences placed 2 orders valued at $3.6 million (16%). All ten task orders are unrestricted, non-set-aside awards. Pricing structures included firm fixed price for administrative operations support and cost-plus fixed fee for clinical execution and development work.

The National Institute of Neurological Diseases and Stroke (NINDS), National Institute of Health (NIH) has awarded a Master IDIQ for a full service, turn-key, Phase I clinical trial operations and facility for the development of novel neurotherapeutic agents. This full service facility would provide a range of services from protocol development/finalization and clinical trial execution through submission of a final clinical study report in support of an IND submission of the tested agent.