Drugs / Antithrombin gamma
Antithrombin gamma
also known as
Acoalan · Afucosylated antithrombin · Antithrombine gamma · Antitrombina gamma · recombinant human antithrombin-gamma · rhAT-gamma
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | ACOALAN® | — | 2016-09-28 | “it has filed an application to Japan's Ministry of Health, Labor and Welfare (MHLW) seeking for manufacturing and marketing approval for an additional formulation” kyowakirin.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT04182373 | Nov 2019 → May 2023 | preeclampsia | Kyowa Kirin, Inc. | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2023-09-28 | Kyowa Kirin, Inc. | Results Kyowa Kirin Announces Top-Line Results of Phase 3 Clinical Study of KW-3357 for the Treatment of Preeclampsia in Japan kyowakirin.com ↗ |
| 2017-09-14 | Kyowa Kirin, Inc. | Regulatory Kyowa Hakko Kirin Acquired Approval for Additional Formulation of ACOALAN® in Japan kyowakirin.com ↗ |
| 2016-09-28 | Kyowa Kirin, Inc. | Regulatory Application seeking Approval for Additional formulation of ACOALAN® in Japan kyowakirin.com ↗ |
| 2015-07-03 | Kyowa Kirin, Inc. | Regulatory Approval for ACOALAN® in Japan kyowakirin.com ↗
it has received approval for thrombophilia due to congenital antithrombin (AT) deficiency (CAD) and disseminated intravascular coagulation (DIC) accompanied by a decrease in AT |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-09-28 | Kyowa Kirin, Inc. | Kyowa Kirin Announces Top-Line Results of Phase 3 Clinical Study of KW-3357 for the Treatment of Preeclampsia in Japan kyowakirin.com ↗ |
| 2017-09-14 | Kyowa Kirin, Inc. | Kyowa Hakko Kirin Acquired Approval for Additional Formulation of ACOALAN® in Japan kyowakirin.com ↗ |
| 2016-09-28 | Kyowa Kirin, Inc. | Application seeking Approval for Additional formulation of ACOALAN® in Japan kyowakirin.com ↗ |
| 2015-07-03 | Kyowa Kirin, Inc. | Approval for ACOALAN® in Japan kyowakirin.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Antithrombin gamma | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04182373 ↗ |
| Known as | Acoalan | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594458 ↗ |
| Known as | Afucosylated antithrombin | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594458 ↗ |
| Known as | Antithrombine gamma | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594458 ↗ |
| Known as | Antitrombina gamma | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594458 ↗ |
| Known as | recombinant human antithrombin-gamma | “a recombinant human antithrombin-gamma (rhAT-gamma) group (n=90)” PMID 41789451 ↗ Mar 2026 |
| Known as | rhAT-gamma | “a recombinant human antithrombin-gamma (rhAT-gamma) group (n=90)” PMID 41789451 ↗ Mar 2026 |
| Modality | Protein / enzyme biologic | “recombinant human antithrombin-gamma” PMID 41789451 ↗ Mar 2026 |
| Route | Intravenous | “Intravenous infusion, once a day, 7 days” NCT04182373 ↗ |