drugset

Drugs / KRN125

Follow last change Jul 2023 re-read 3 minutes ago

KRN125

also known as pegfilgrastim

Developed for: lymphoid neoplasm
Investigated by: Kyowa Kirin, Inc.

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed	Japan (PMDA)	—	chemotherapy-induced toxicity	2013-06-27	“it has filed an application for marketing approval to the Ministry of Health, Labour and Welfare (MHLW) for sustained-duration G-CSF product KRN125” kyowakirin.com ↗

Trials 1

today NCT05007652 · Ph 2

20222023202420252026

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 2	NCT05007652	Sep 2021 → Oct 2022	lymphoid neoplasm	Kyowa Kirin, Inc.	Completed	Met primary

News releases announcing trial results or a regulatory action · 6

Date	Issuer	Release
2023-07-24	Kyowa Kirin, Inc.	Regulatory Kyowa Kirin Announces Application for Partial Change of Approved Indication of G-Lasta® for the Mobilization of Hematopoietic Stem Cells into Peripheral Blood for Autologous Blood Stem Cell Transplantation in Japan kyowakirin.com ↗ Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151, President and CEO: Masashi Miyamoto) announced that the company has filed an application for partial change of approved indication
2022-04-04	Kyowa Kirin, Inc.	Results Safety Data from a Clinical Trial of Automated InjectionDevice of G-Lasta® was Reported kyowakirin.com ↗ The study enrolled 35 patients and no serious adverse events or febrile neutropenia occurred.
2021-03-12	Kyowa Kirin, Inc.	Regulatory Kyowa Kirin Announces Application for Partial Change of Approved Indication of G-Lasta® for the Mobilization of Hematopoietic Stem Cells into Peripheral Blood for Allogeneic Blood Stem Cell Transplantation in Japan kyowakirin.com ↗
2014-09-26	Kyowa Kirin, Inc.	Regulatory Approval for Sustained-Duration G-CSF Product G-Lasta® in Japan kyowakirin.com ↗ Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that it has received approval for sustained-duration G-CSF product G-Lasta® subcutaneous injection 3.6mg (G-Lasta®) [generic name: pegfilgrastim (genetical recombination)] by the Ministry of Health, Labour and Welfare (MHLW).
2013-06-27	Kyowa Kirin, Inc.	Regulatory Kyowa Hakko Kirin Submits Application for Approval in Japan for Sustained-Duration G-CSF Product (KRN125) kyowakirin.com ↗
2013-01-25	Kyowa Kirin, Inc.	Results Results of Phase 3 Clinical Trials of KRN125 in Patients with Malignant Lymphoma and Breast Cancer in Japan kyowakirin.com ↗

All press releases naming this drug 6 releases

Date	Issuer	Release
2023-07-24	Kyowa Kirin, Inc.	Kyowa Kirin Announces Application for Partial Change of Approved Indication of G-Lasta® for the Mobilization of Hematopoietic Stem Cells into Peripheral Blood for Autologous Blood Stem Cell Transplantation in Japan kyowakirin.com ↗
2022-04-04	Kyowa Kirin, Inc.	Safety Data from a Clinical Trial of Automated InjectionDevice of G-Lasta® was Reported kyowakirin.com ↗
2021-03-12	Kyowa Kirin, Inc.	Kyowa Kirin Announces Application for Partial Change of Approved Indication of G-Lasta® for the Mobilization of Hematopoietic Stem Cells into Peripheral Blood for Allogeneic Blood Stem Cell Transplantation in Japan kyowakirin.com ↗
2014-09-26	Kyowa Kirin, Inc.	Approval for Sustained-Duration G-CSF Product G-Lasta® in Japan kyowakirin.com ↗
2013-06-27	Kyowa Kirin, Inc.	Kyowa Hakko Kirin Submits Application for Approval in Japan for Sustained-Duration G-CSF Product (KRN125) kyowakirin.com ↗
2013-01-25	Kyowa Kirin, Inc.	Results of Phase 3 Clinical Trials of KRN125 in Patients with Malignant Lymphoma and Breast Cancer in Japan kyowakirin.com ↗

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

Field	Value	Cited text
Known as	KRN125	ClinicalTrials.gov intervention name — accepted as the source's own label NCT05007652 ↗
Known as	pegfilgrastim	“KRN125(pegfilgrastim), PLR001(plerixafor)” NCT05007652 ↗