- Clinigen obtained approval for Prolacta’s “PreemieFort® Enteral Solution”, a human milk-based fortifier, as an approved pharmaceutical product in Japan indicated for the “Nutritional management of neonates and infants presenting with weight gain failure such as very low birth weight (VLBW) infants.”
- The approval was supported by data from the pivotal Japan-based JASMINE Phase III clinical trial, a randomised, open-label, parallel-group comparison study in VLBW infants.
- This first-of-its kind approval set a new regulatory precedent, bridged innovation to market access gaps, and most importantly, advanced infant care and patient access in a rigorous regulatory environment.
LONDON,
Feb. 12, 2026 /PRNewswire/ —
Clinigen, the global pathfinder accelerating patient access to critical medicines across the lifecycle, today announces a landmark regulatory achievement in the Japanese market. In a pharmaceutical industry-first, Clinigen K.K., in partnership with Prolacta Bioscience®, has successfully obtained the approval of “PreemieFort® Enteral Solution” as a pharmaceutical product with the Ministry of Health, Labour and Welfare.
While regulated as an infant formula in the U.S. and Europe, Prolacta Bioscience’s “PreemieFort® Enteral Solution”, was successfully approved in Japan as a pharmaceutical product, marking the world’s first prescription drug approval for a nutritional fortifier made from human milk. With no existing approved drugs made from human milk, Prolacta’s quality and safety standards met Japan’s rigorous pharmaceutical standards.
Along with Clinigen’s leading regulatory expertise, the two companies pioneered, defined, and executed the regulatory architecture to meet the quality, safety and efficacy required for pharmaceutical approval. This success is further made more notable hailing from Japan, a global leader in neonatal care with some of the highest preterm survival rates. Prolacta has appointed Clinigen as its exclusive licensee and Marketing Authorisation Holder in Japan.
Fortifiers derived from human milk form part of nutritional strategies for specific patient populations. While the category remains specialised, its continued growth highlights the increasing importance of robust regulatory frameworks to support product safety, quality, and patient access. Clinigen’s recent regulatory approval in Japan reflects the company’s continued focus on navigating complex regulatory environments to support access to specialised products.
Prolacta’s “PreemieFort® Enteral Solution” is designed for VLBW infants, and in other neonates and infants in particular if the following conditions indicate failure to gain weight, such as congenital gastrointestinal disorders or congenital heart diseases, and those recovering from gastrointestinal surgery. The approval acknowledges the critical role of human milk-based nutrition for these at-risk babies.
Extensive clinical data, including the JASMINE Phase III trial, supported Clinigen’s regulatory strategy to secure pharmaceutical approval in Japan.
“Japan’s approval reflects a clear regulatory judgment that this category warrants pharmaceutical-level oversight.” Dr. Varun Sethi, CEO, Clinigen commented, “Our role was to work closely with regulators to define a pathway where none previously existed, enabling a human milk-based product such as “PreemieFort® Enteral Solution” to be reviewed and approved to the standards applied to medicines. This ensures that patient access is determined by quality safety, and efficacy, not geography. We took a complex, new science asset and updated its regulatory status in Japan, unlocking a major market for our partner while helping to address the needs of vulnerable infants.”
Scott Elster, CEO, of Prolacta said: “We are proud to have broken through this regulatory ceiling with our partners at Clinigen. Securing Japan’s approval for the world’s first human milk-based fortifier as an important medicine in Japan underscores the strength of our pharmaceutical-grade manufacturing, quality systems, and clinical evidence. Clinigen’s regulatory expertise, combined with Prolacta’s patented human milk-based products, helped make this landmark approval possible, and enables access to more babies in need worldwide.“
This press release contains information about medicines that are not approved in the relevant territories. Not all products or indications described are available in every market. The intent of this press release is to share pertinent information with the investment community about this collaboration between Clinigen and Prolacta. This communication does not constitute, and should not be construed as, promotion or advertising for any medicine or indication.
About Clinigen
Clinigen is a global pharmaceutical services company trusted by over 1,000 pharma and biotech partners. With more than 35 years of experience, we accelerate access to critical medicines at every stage of the product lifecycle. As pathfinders, our team of over 1,100 specialists expertly navigate the complexities of clinical trial supply, early access programs, regulatory services, and long-term commercialisation through both licensed and unlicensed pathways. Operating across five continents, we deliver innovative solutions to over 130 countries each year. Whatever the challenge, we find a way.
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