Drugs / HEPATOPOIETIN-A
HEPATOPOIETIN-A
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00225901 | Sep 2005 → ? | acute liver failure | Kyoto University, Graduate School of Medicine | Unknown | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT04906083 Background | Feb 2021 → Dec 2022 | cirrhosis of liver, liver failure, thrombocytopenia | Tongji Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2026-09-24 | Kringle Pharma, Inc. | Regulatory Kringle Pharma Announces IND Submission to the U.S. FDA for Oremepermin Alfa for the Treatment of Acute Spinal Cord Injury kringle-pharma.com ↗
announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for oremepermin alfa, a recombinant human hepatocyte growth factor (HGF), to initiate a Phase 3 clinical trial in the U.S. for the treatment of acute spinal cord injury (SCI). |
| 2026-07-28 | Kringle Pharma, Inc. | Results Publication of a Scientific Paper Reporting Results from the Japanese Phase 3 Study of HGF (Hepatocyte Growth Factor) for Acute Spinal Cord Injury kringle-pharma.com ↗
Publication of a Scientific Paper Reporting Results from the Japanese Phase 3 Study of HGF (Hepatocyte Growth Factor) for Acute Spinal Cord Injury |
| 2026-07-28 | Kringle Pharma, Inc. | Results 脊髄損傷急性期に対するHGF（肝細胞増殖因子）の第III相臨床試験結果に関する論文発表のお知らせ kringle-pharma.com ↗ |
| 2026-06-19 | Kringle Pharma, Inc. | Regulatory 脊髄損傷急性期に対するHGF（肝細胞増殖因子）の第III相追加試験における治験計画届書の提出について kringle-pharma.com ↗ |
| 2025-12-15 | Kringle Pharma, Inc. | Regulatory 脊髄損傷急性期を対象とする組換えヒトHGFタンパク質「oremepermin alpha」の欧州における希少疾病用医薬品指定に向けた申請のお知らせ kringle-pharma.com ↗ |
| 2025-06-11 | Kringle Pharma, Inc. | Regulatory U.S. FDA Orphan Drug Designation Granted to Recombinant Human HGF, KP-100IT,for the Treatment of Acute Spinal Cord Injury kringle-pharma.com ↗
Kringle Pharma, Inc. (Head office located in Osaka , Japan ; “KRINGLE”), a late clinical-stage biopharmaceutical company, today announced that the United States (U.S.) Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to KP-100IT, the intrathecal formulation of recombinant human hepatocyte growth factor (HGF), for the treatment of the acute phase of spinal cord injury. |
| 2025-06-11 | Kringle Pharma, Inc. | Regulatory 脊髄損傷急性期を対象とする組換えヒトHGFタンパク質（KP-100IT）米国における希少疾病用医薬品指定の取得のお知らせ kringle-pharma.com ↗ |
| 2024-03-14 | Kringle Pharma, Inc. | Results 脊髄損傷に対してHGFを投与したときの遺伝子発現プロファイルに関する論文発表のお知らせ kringle-pharma.com ↗ |
| 2024-02-09 | Kringle Pharma, Inc. | Results Topline Data from Phase 3 Study of KP-100IT in Acute Spinal Cord Injury kringle-pharma.com ↗
today announces topline data from a nonrandomized, multicenter, confirmatory Phase 3 study investigating KP-100IT, the intrathecal formulation of recombinant human HGF, in subjects with acute spinal cord injury. |
| 2024-02-09 | Kringle Pharma, Inc. | Results 脊髄損傷急性期に対する第III相臨床試験の速報結果のお知らせ kringle-pharma.com ↗ |
| 2023-10-30 | Kringle Pharma, Inc. | Results Publication of Preclinical Results from Joint Research with Keio University on Severe Spinal Cord Injury kringle-pharma.com ↗
The finding led to the patent application claiming a priority, jointly filed by KRINGLE and Keio University as announced in the KRINGLE news release dated September 8, 2023. |
| 2023-10-30 | Kringle Pharma, Inc. | Results 重度脊髄損傷に対する当社と慶應義塾大学による共同研究成果の論文掲載に関するお知らせ kringle-pharma.com ↗ |
| 2023-02-01 | Kringle Pharma, Inc. | Results Publication of Combined Treatment for Chronic Complete Spinal Cord Injury kringle-pharma.com ↗
The publication in Biomaterials details the results of this study. |
| 2023-02-01 | Kringle Pharma, Inc. | Results 慢性期完全脊髄損傷に対する複合治療研究成果の論文掲載に関するお知らせ kringle-pharma.com ↗ |
| 2022-10-24 | Kringle Pharma, Inc. | Regulatory A Phase III Study of HGF in Vocal Fold Scar: Submission of the Clinical Trial Application kringle-pharma.com ↗
today announce s that the clinical trial application has successfully submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan to initiate a Phase III study of recombinant human HGF (KP-100LI) in patients with vocal fold scar. |
| 2022-10-24 | Kringle Pharma, Inc. | Regulatory 声帯瘢痕に対するHGF（肝細胞増殖因子）の第III相臨床試験 治験計画届提出について kringle-pharma.com ↗ |
| 2022-08-12 | Kringle Pharma, Inc. | Results Update on the Investigator-initiated Phase 2 Study in Patients with ALS kringle-pharma.com ↗
As a result, there was no statistically significant difference between the KP-100IT group and the placebo group. |
| 2022-08-12 | Kringle Pharma, Inc. | Results ALSを対象とする第II相臨床試験（医師主導治験）に関するお知らせ（速報） kringle-pharma.com ↗ |
| 2021-05-25 | Kringle Pharma, Inc. | Regulatory クラリス・バイオセラピューティクス社が米国で IND 申請 kringle-pharma.com ↗ |
All press releases naming this drug 19 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HEPATOPOIETIN-A | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298081 ↗ |
| Known as | Hepatocyte growth factor | “Standard medical treatment included transmetil, compound glycyrrhizinate, reduced glutathione and hepatocyte growth factor, et. al.” NCT04906083 ↗ |
| Known as | HGF | “Hepatocyte growth factor (HGF) is one of major agents stimulating liver regeneration and ameliorating hepatic injury.” NCT00225901 ↗ |
| Known as | Recombinant human hepatocyte growth factor | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298081 ↗ |
| Modality | Protein / enzyme biologic | “In this study, recombinant human HGF is administered to patients with fulminant hepatic failure or LOHF.” NCT00225901 ↗ |