Producer
Astellas Pharma Inc.
Japanese pharmaceutical company; originator of tacrolimus (FK506 / Protopic®) for atopic dermatitis and Prograf® for organ transplant; tacrolimus was discovered from soil bacterium Streptomyces tsukubaensis sampled near Mount Tsukuba, Japan in 1984; the dermatology formulation opened a new non-steroidal treatment class.
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Oncology
35%Urology
20%Transplant Immunosuppression
20%Dermatology
10%Cell Therapy & Advanced Modalities
15%
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Origin2022
Tacrolimus was discovered from a soil sample taken near Mount Tsukuba, Japan — the bacterium that produces it was named after the mountain. It became the first non-steroidal treatment for eczema in 35 years. In 1984, researchers at Fujisawa Pharmaceutical (later merged into Astellas Pharma) collected a soil sample from the foothills of Mount Tsukuba, ~60 miles northeast of Tokyo. The sample contained a novel Streptomyces species they named S. tsukubaensis. The bacterium produced a macrolide compound — FK506 (tacrolimus) — that proved to be a potent immunosuppressant. Originally developed for organ transplant rejection (Prograf®), tacrolimus's immunomodulatory mechanism was later adapted for topical use in atopic dermatitis as Protopic® ointment (0.03% and 0.1%), approved by FDA in 2000. Protopic was the first new non-steroidal mechanism approved for eczema since topical corticosteroids were introduced in the 1950s — ending a 35-year therapeutic drought for patients with steroid-dependent or steroid-resistant disease.
Astellas Pharma Inc. ↗Did you know2023
Tacrolimus, the active ingredient in both Astellas Prograf (systemic, for organ transplant) and Protopic (topical, for eczema), is the same molecule administered in completely different contexts with very different risk profiles. Systemic tacrolimus in transplant patients is dosed at 1-15 nanograms/mL blood levels -- enough to suppress the entire immune system, with life-threatening risks of infection, kidney damage, and cancer if over-dosed. Topical tacrolimus on eczema skin produces blood levels 100-1000x lower, suppressing only the local immune response. The FDA required a black box warning on Protopic in 2006 for a theoretical cancer risk -- despite the evidence suggesting topical exposure does not reach systemic immunosuppressive levels. The supply chain for the tacrolimus API that goes into transplant Prograf capsules and eczema Protopic ointment is shared: if Fujisawa Chemical (the API maker) faces a manufacturing disruption, both transplant rejection prevention programs AND eczema treatment simultaneously face shortage.
Astellas Pharma Inc. ↗