Twenty (20) pharmaceuticals have been designated as the accelerated review process of SAKIGAKE designation which started since 2015. 8 pharmaceuticals out of 20 products have been approved and 4 pharmaceuticals have been in phase III stages. Eleven (11) regenerative medicines have been designated as SAKIGAKE designation and 2 regenerative medicines have been approved. Two in vitro diagnostics have been designated as SAKIGAKE designation and the one has been approved.
Pharmaceuticals
| Date | Product Name | Applicant Name | Intended Indication | Status |
| 2016 | Sirolimus(NPC-12G) | Nobel Pharma | Facial Angiofibroma(FA) caused by tuberous sclerosis complex(TSC) | Approved[Mar/2018]
Price addition: 10% RapalimusGel ラパリムスゲル |
| 2016 | NS-065/NCNP-01
viltolarsen |
Nippon Shinyaku | Duchenne muscular dystrophy：DMD | Approved [MAR/2020]
ビルトラセン |
| 2016 | S-033188
Baloxavir marboxil |
Shionogi | Type A or B Influenza infection | Approved[Feb/2018]
Price addition:10% XOFLUZAゾフルーザ |
| 2016 | BCX7353
selective inhibitor of plasma kallikrein |
BioCryst Pharmaceuticals
(IDA) |
the prevention of hereditary angioedema (HAE) attacks in patients diagnosed with HAE | ODD[19NOV2019] |
| 2016 | ASP2215(Gilteritinib) | Astellas | Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation | Approved [Sep 2018]
Price addition:10% Zosupata |
| 2016 | Pembrolizumab | MSD( Merck) | gastric cancer which is impossible of curative resection | Cancelled [2017/Sep] |
| 2017 | olipudase α | Sanofi | ニーマンピック病A/B型 – 酸性スフィンゴミエリナーゼ欠乏症 | Phase II |
| 2017 | Aducanumab | Biogen | アルツハイマー病の進行抑制 | Discontinuation |
| 2017 | DS-5141b | Daiichi-Sankyo | Duchenne muscular dystrophy | PhaseI/II |
| 2017 | SPM-011
Boropharan
|
Stella Pharma | Approved[MAR/2020]
Steboronine |
|
| 2017 | Nivolumab | Ono Pharma | biliary tract cancer | Phase II |
| 2018 | RTA 402(バルドキソロンメチル)
|
Kyowa Hakko Kirin | Diabetic kidney disease | Phase III |
| 2018 | JR-141 | JCR Pharmaceuticals | Mucopolysaccharidosis II (Hunter syndrome) | Phase III |
| 2018 | Tafamidis Meglumine | Pfizer | Transthyretin cardiac amyloidosis (TTR-CM) | Approved[Mar 2019]
Vyndagelビンダケル |
| 2018 | tepotinib MSC2156119J | Merck Serono | Advanced (Stage IIIB/IV) non-small cell lung cancer harboring MET exon 14 skipping mutations | ODD[19NOV2019]
Approved[MAR/2020] Tepmetko |
| 2018 | Trastuzumab deruxtecan
|
Daiichi Sankyo | HER2-overexpressing unresectable advanced/ recurrent gastric cancer which have progressed after chemotherapy | Phase II |
| 2018 | Entrectinib | Ignyta/ Chugai | Adult and pediatric patients with locally advanced or metastatic NTRK fusion-positive solid tumors, either whose disease progressed following prior therapy or who have no acceptable standard therapies | Approved [JUN/2019]
Price addition:10% ROZLYTREKロズリート |
| 2019 | Valemetostat(DS3201) | Daiichi-Sankyo | 再発または難治性の末梢性T細胞性リンパ腫 | Phase II |
| 2019 | イキサゾミブクエン酸エステル
ixazomib citrate |
Takeda | ALアミロイドーシス | Discontinuation
|
| 2019 | TAK-925 | Takeda | Narcolepsy | Phase I |
| 2019 | ASP-1929 | Rakuten Medical | 頭頸部癌/Head and Neck Cancer | Phase III |
| 2019 | E7090 | Esai | biliary tract cancer | Phase II |
|
Regenerative Medicine |
||||
| 2016 | STR01
Stemirac |
Nipro | 骨髄損傷
札幌医科大学・本望教授 |
Approved [Dec/2018]
Stemirac |
| 2016 | G47A | Daiichi-Sankyo | 悪性脳腫瘍（神経膠腫）
東大医科研・藤堂教授 |
Phase II |
| 2016 | JRM-001
時価心臓内幹細胞 |
日本再生医療 | 小児先天性心疾患
岡山大学・王教授 |
Phase III |
| 2017 | CLS2702C/D
口腔粘膜由来食道細胞シート |
Cellseed | 食道がん手術後
東京女子医科大学・岡野教授 |
Phase III |
| 2017 | 非自己iPS細胞由来ドパミン神経前駆細胞 | DaiNipponSumito(DNP) | パーキンソン病
京都大学CiRA・高橋教授 |
Phase I/II |
| 2017 | ヒト（同種）成人骨髄由来多能性前駆細胞 | Hellios | 急性期の脳梗塞 | Phase II/III |
| 2018 | TBI-1301
NY-ESO-1/siTCR
|
Takara Bio
Otsuka |
The gene of the receptor that specifically recognizes the tumor antigen is transduced ex-vivo to lymphocytes of patients, and the gene-modified lymphocytes are infused back to the patients. It acquires the capability to attack cancer cells and the treatment of synovial sarcoma. | PhaseI/II |
| 2018 | CLBS12
CD34陽性細胞 |
Caladrius Biosciences | By isolating CD34 + cells from the patients’ own peripheral blood and infuse back to the patients, CD34 + cells promote angiogenesis, resulting in an improvement from critical limb ischemia conditions. | PhaseII |
| 2018 | AVXS-101
SMN遺伝子治療 |
AveXis
NOVARTIS |
This product is for the treatment of spinal muscular atrophy (SMA), by transducing SMN gene into patients, producing SMN protein in the body and supplementing, then improving the functions of nerve and skeletal muscle. | Approved [MAR/2020] |
| 2019 | OBP-301(テロメライシン) | Oncolys / Chugai | 食道癌（Esophageal cancer） | PhaseII |
| 2019 | SB623 | SunBio | 外傷性脳損傷における運動障害改善 | Phase II |
|
In vitro diagnostics |
||||
| 2016 | Titanium Bridge | Nobel Pharma | Launched [2018/06/01] | |
| 2016 | Otsuka | Cancelled | ||
| 2017
|
人工気管 | DaiichiIka | ||
| 2017 | BNCTシステム | Sumitomojuki | ホウ素中性子補足療法 | |
| 2017 | UT-Heart | UT-Heart | 心臓シュミレーションプログラム | |
| 2017 | がん関連遺伝子パネル検査システム | シスメックス | Approved [Dec/2018] | |
| 2018 | Cardiovascular-patch
OFT-G1 (tentative) |
Teijin | Cardiovascular-patch consisting of absorbable synthetic polymer stitches, non-absorbable synthetic polymer stitches and cross-linked gelatin membrane, used for correction of vessels, securing of blood flow, construction /reconstruction of surrounding tissues during cardiovascular surgery. | |
| 2018 | CliniMACS
CD34 System
|
Miltenyi Biotec | Selectively isolate CD34 + cells, and administer obtained CD34 + cell with collagen soft tissue injection (scaffold material) to the refractory bone fracture (nonunion) site, and accelerate bone adhesion. | |
| 2019 | マイクロ波マンモグラフィ | Integral Geometry Science | ||
| 2019 | 下肢動脈バイパス用人工血管作製用鋳型 | バイオチューブ
|
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| 2019 | リン酸化プルランバイオアドヒーシブ | BioARC | ||
| 2019 | DNAチップによる膵臓・胆道癌検査キット | 東レ
|
PhaseI | |