Nobelpharma Co., Ltd. (Tokyo, rare disease pharma; NPC-31 prion disease program)

Nobelpharma is a Tokyo drug and device company founded in 2003 that describes its focus as critical but neglected diseases, mostly rare conditions. It sells products in Japan, the US, Europe and China, and lists a pipeline of about 18 items, one of which is NPC-31 (P092 maleate) for prion disease, developed with Gifu University and shown as phase I/II, in preparation, as of March 2026. It is the only commercial sponsor of a small-molecule prion programme currently in the atlas. Information only.

Key facts

  • Established 6 June 2003; headquarters at 1-17-24 Shinkawa, Chuo-ku, Tokyo; Jin Shiomura is Managing Director and CEO; 361 employees at 31 December 2025.
  • The company states it works on critical but neglected drugs and medical devices, with R&D plus distribution of medical products.
  • Its first products launched in 2008, including NOBELZIN for Wilson disease; RAPALIMUS (sirolimus) followed in 2014-2015 as a treatment for lymphangioleiomyomatosis.
  • HYFTOR (sirolimus topical gel) was approved by the US FDA and launched in the US in August 2022, then approved in the EU and UK in 2023; the company marked four years of US sales on 2 October 2026.
  • Overseas subsidiaries were set up in 2019-2020 in the US, Germany and China (Nobelpharma America, Plusultra pharma, Jiangsu Nobelpharma).
  • The March 2026 pipeline lists NPC-31 P092 maleate for prion disease at phase PI/II, status in preparation, partner Gifu University, expected approval timing TBD.
  • Other pipeline items include naxitamab for neuroblastoma with Y-mAbs, ubiquinol for multiple system atrophy (phase III, University of Tokyo) and a platelet aggregation promoter at preclinical stage. The page says dates are expectations.
  • Gifu University's Kazuo Kuwata is the inventor on US9809563, a maleic acid salt of an anti-prion compound; assignment to Nobelpharma was recorded 2022-02-11.
  • A Nobelpharma project manager told the July 2025 CJD Foundation conference that several essential non-clinical studies were complete and clinical studies were expected probably the following year; no trial is listed on the Foundation page.

Timeline

  1. 2003Company established.
  2. 2008First product launches.
  3. 2014RAPALIMUS launched for LAM.
  4. 2022NPC-31 patent assignment from Gifu University recorded.
  5. 2022HYFTOR US launch.
  6. 2025Presentation at the CJD Foundation Family Conference.
  7. 2026Pipeline table shows NPC-31 in preparation for phase I/II.

Last checked 1 November 2026

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