Clinical development plan

Our clinical studies
and a short route to market

Isofol has managed to achieve a truly significant reduction of 3-4 years in the development time for arfolitixorin, thereby reducing development costs by several hundred millions of kronor. This has been achieved thanks to the pharmaceutical authorities (the FDA in the USA, the EMA in Europe, and the Medical Products Agency in Sweden) having authorised Isofol to move directly from a phase IIa study to the ongoing pivotal phase III study, AGENT, as an IND (Investigational New Drug). The abbreviated process is due to the fact that arfolitixorin is based on the already known and applied substance, MTHF, which is present in existing drugs – the prodrugs, leucovorin and levoleucovorin, but which must be metabolised endogenously to be effective, a genetically linked ability that varies from one individual to another.

Timeline AGENT study 440 patients