Gelteq plans to begin a preclinical bioequivalence program in September 2025 for a gel-based oral formulation of a widely used antihistamine, with work to be executed by Adgyl Lifesciences, a partner of Eurofins Advinus. The company’s stated aim is to advance to human studies and pursue U.S. approval via the 505(b)(2) pathway, leveraging existing safety and efficacy data for the reference drug while bridging with new pharmacokinetic data for the novel dosage form.
The move is a classic reformulation strategy in a crowded, genericized category where differentiation relies on format, usability, and dosing flexibility rather than a new mechanism. A gel vehicle addresses adherence and administration pain points common in pediatrics and older adults, including swallowing difficulties, taste issues, and dose titration challenges. For 505(b)(2), the practical gating items are human bioequivalence under fed/fasted conditions against the chosen reference product, characterization of any novel excipients, and robust CMC for a semi-solid matrix. If Gelteq ultimately pursues OTC status, additional consumer behavior work—label comprehension, self-selection, and potentially actual-use studies—would be expected, which typically extends timelines beyond an initial prescription launch. Mention of veterinary utility signals optionality, but it sits on an entirely separate FDA-CVM track and cannot be packaged into the same application.
Operationally, this is a small, fast program by drug development standards, skewing toward healthy-volunteer crossover PK with intensive sampling and tight bioanalytical turnarounds. Site demand will center on Phase 1 units rather than large community networks. However, any pediatric palatability or acceptability assessments—if used to support labeling—will require specialized centers and careful protocol design to avoid confounding taste-masking claims with efficacy. CRO selection will hinge on bioanalytical capacity, experience with semi-solid characterization, and device/packaging validation if unit-dose sachets or calibrated dispensers are part of the product. On the CMC side, the critical risks are stability of the active in an aqueous gel, preservative strategy, viscosity control for dose reproducibility, and scale-up of fill-finish with content uniformity across lots.
Strategically, a gel format aims to carve out a niche in an already saturated antihistamine market, which is dominated by tablets, liquids, ODTs, and chewables. The path to meaningful differentiation is narrow: without a clinically supported claim such as faster onset or improved nighttime tolerability, the product will compete on administration preference and dosing flexibility. That can work in pediatrics or dysphagia populations, but exclusivity is limited. Three-year 505(b)(2) exclusivity is possible if new clinical investigations are deemed essential to approval, yet it would not block competitors from pursuing alternative gel technologies around the same active. Naming the specific antihistamine will also matter, as food-effect profiles, bitterness, and stability vary significantly across actives like cetirizine, loratadine, and fexofenadine, which drives both study design and CMC complexity.
The following milestones to watch are identification of the reference listed drug, the human BE protocol specifics—including fed/fasted conditions, crossover design, and 90% confidence intervals for Cmax and AUC—and whether Gelteq seeks initial prescription labeling or heads directly to OTC. Any inclusion of novel excipients would signal a broader nonclinical package and could slow timelines. If the company can demonstrate clean bioequivalence, stable shelf life, and reproducible dosing in a scalable format, 505(b)(2) is a viable path; the commercial question is whether format-led differentiation can carve out share in a mature category and justify the additional studies required to support pediatric and OTC claims.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
