PINNEBERG, Germany – August 24th, 2026 – photonamic GmbH & Co. KG is pleased to announce that EMA will be evaluating the scientific content of their Type II Variation for Gliolan® (5-aminolevulinic acid hydrochloride, 5-ALA) for visualization of tumour tissue during surgery for newly diagnosed or recurrent meningioma (WHO Type I-III). The application is based on the data from the MEN-301 Study, a multicenter phase III study conducted in the EU and US.
This marks the first submission of an additional indication to the EMA since our original approval for Gliolan in adults for visualisation of malignant tissue during surgery for malignant glioma (WHO grade III and IV), in 2007. This submission was made possible by the hard work of our colleagues at photonamic, and the NX Development Corp. (NXDC) team who conducted the MEN 301 study and analysed the data.
“This EMA submission represents another important milestone for the whole group, having submitted to the FDA in April,” added Dr. Ulrich Kosciessa, CEO of photonamic GmbH & Co. KG. and Chairman of the Board of NXDC. “We are pleased to have reached this next stage and remain focused on advancing 5-ALA in fluorescence-guided surgery to help address unmet medical needs worldwide.”
About photonamic GmbH & Co KG
photonamic is a German based company focused on the development and manufacturing of 5-ALA in various applications in the healthcare field. As a member of the SBI group with its parent company SBI ALApharma, the main achievement of photonamic to date is the development and registration of 5-ALA for the fluorescence-guided resection of glioblastoma, which is marketed as Gliolan®, Gleolan® or Alabel™ in Europe, United States, Canada, Japan, Australia and Korea. Within the group, photonamic and its affiliated companies in the US, Canada and Japan are diligently extending the development activities with 5-ALA even outside the field of fluorescence guided resection and photodynamic application, e.g. immune modulation in infectious diseases, food supplement and cosmetics.
About Gliolan® (5-aminolevulinic acid hydrochloride)
Gliolan® is indicated in adults for the visualisation of malignant tissue during surgery for malignant glioma (WHO grade III and IV). It is taken orally by the patient prior to surgery. In combination with a specialist surgical microscope and blue light source, Gliolan® causes the malignant part of the tumour to fluoresce enabling the surgeon to make a distinction between malignant and normal tissue.