Hollenbeck Diagnostic
New Product for Diagnosis of Growth Hormone Deficiency (GHD)
Hollenbeck Pharmaceuticals plans to bring a new Growth Hormone Deficiency (GHD) diagnostic for adults and children to the market. The FDA has granted it orphan drug designation which provides us with incentives, including market exclusivity.
Supported by extensive research on the diagnostic, previous FDA approval, and interest from clinicians, this is a high confidence project with modest start-up costs and a short time to revenue.
For more information, contact using the link below.
Hollenbeck Pharmaceutics Poised to Revolutionize GHD Care with Dual FDA Pre-IND Milestone for HOL-101
August 20, 2025
Hollenbeck Pharmaceutics Inc., a trailblazer in endocrine innovation, is excited to announce that the U.S. Food and Drug Administration (FDA) has granted a Pre-Investigational New Drug (Pre-IND) meeting request for HOL-101, our synthetic Growth Hormone-Releasing Hormone (GHRH) 1-44 amide analog. This key step includes Written Responses Only (WRO) slated for September, offering critical guidance on our development plan to bring both a therapeutic and diagnostic solution for Growth Hormone Deficiency (GHD) to market. The diagnostic, potentially the faster to market, could transform GHD diagnosis, while the therapeutic addresses treatment needs.
HOL-101, backed by Orphan Drug Designations for treatment (#14-4368) and diagnosis (#DRU-2020-7854), leverages GHRH’s natural GH stimulation mechanism. Our proposed study, detailed in the Pre-IND package, aims to streamline nonclinical, clinical, and regulatory pathways under 505(b)(2), using existing data to expedite both applications. The WRO will clarify trial designs and PK bridging, positioning us to accelerate the diagnostic’s market entry and support the therapeutic’s efficacy.
“We’re thrilled with this FDA engagement, which validates our dual-purpose strategy for,” said Bill Jenks, CEO of Hollenbeck Pharmaceutics. “The upcoming responses will guide us toward bringing these innovations to patients faster, with the diagnostic leading the way.”
With a $5 billion+ global GHD market, HOL-101’s ODD benefits—market exclusivity and priority review—enhance its appeal. Hollenbeck is actively seeking co-development or licensing partners to maximize this asset’s potential, inviting collaboration to fast-track these breakthroughs.
Investors and partners interested in rare disease opportunities, contact us either directly (bill@hollenbeckpharma.com) or message us below to explore how we can advance HOL-101 together.