LAVAL, Québec — September 24, 2026
Altasciences announced that its formulation development, manufacturing and quality support for 4B Healthcare Inc. has helped advance RhineX, a steroid nasal irrigation rinse, toward clinical testing. Following several months of formulation development, R&D manufacturing, stability testing and quality assurance activities at Altasciences’ CDMO facility in Harleysville, Pennsylvania, 4B Healthcare received FDA clearance to proceed with clinical testing under an IND. First-subject dosing is planned for October 2026, approximately seven months after formulation development began.
RhineX Advances Toward First-in-Human Evaluation
RhineX is a medicated nasal rinse platform being developed for allergic rhinitis and chronic sinusitis, with the company describing the product as a potential first-in-class approach to steroid nasal irrigation. The platform is designed to distribute medication throughout the nasal cavity using a proprietary sachet developed by 4B Healthcare. The company is building RhineX on the established use of steroid rinses in ENT and allergy practice while seeking to develop a pharmaceutical product intended to provide an alternative approach for patients whose symptoms are not adequately controlled with conventional medical therapy.
Altasciences Supports Formulation and CMC Development
The development program included low- and high-dose steroid formulation optimization, prototype evaluation, R&D batch manufacturing and packaging into 4B’s proprietary sachets. Altasciences also supported analytical method development and qualification, accelerated stability testing, packaging evaluation and CMC consulting, including specification-setting activities. cGMP and quality assurance support were provided to help transition the selected formulation toward clinical use and regulatory submission.
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Phase I Study to Be Conducted Through Integrated Services
The planned Phase I clinical study will be conducted at Altasciences’ Los Angeles facility, with bioanalytical support from the company’s laboratory in Greater Montréal and additional CRO services supporting the program. The integrated development model is intended to maintain continuity from formulation and manufacturing through clinical and bioanalytical execution. With FDA clearance now secured and first dosing planned for October 2026, RhineX is moving into clinical development, where safety, tolerability and other clinical characteristics will be evaluated in human subjects.
Source :Altasciences,, press release
