Drugs / Guadecitabine
Guadecitabine
also known as
SGI-110 · Guadecitabina · guadecitabine (SGI-110) · GUADECITABINE SODIUM · S110 sodium salt · Sgi-110 free acid · SGI-110 sodium salt
Trials 33
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2020-10-15 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Otsuka and its subsidiary Astex announce results of phase 3, ASTRAL-2 and ASTRAL-3 trials of guadecitabine in patients with previously treated AML and MDS/CMML otsuka.co.jp ↗
Neither the ASTRAL-2 trial in patients with AML nor the ASTRAL-3 trial in patients with MDS or CMML met the primary endpoint of statistically significant (p <0.05) improvement in overall survival (OS) compared with the control arm of physicians' choice of alternative therapy. |
| 2018-07-31 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Otsuka and Astex announce results of the phase 3 ASTRAL-1 study of guadecitabine (SGI-110) in treatment-naïve AML patients ineligible to receive intense induction chemotherapy otsuka.co.jp ↗
The study did not meet its co-primary endpoints: complete response (CR) rate (p>0.04), and overall survival (OS) (p>0.01) as per the protocol analysis plan, compared with the control arm of physician's choice of azacitidine, decitabine, or low-dose cytarabine. |
| 2015-10-06 | Astex Pharmaceuticals, Inc. | Regulatory Astex Pharmaceuticals Announces Orphan Drug Designation for Guadecitabine (SGI-110) in the Treatment of Acute Myeloid Leukemia astx.com ↗
FDA has granted an orphan drug designation for Astex Pharmaceuticals’ investigational drug, guadecitabine (SGI-110), in the treatment of acute myeloid leukemia (AML). |
| 2015-08-18 | Astex Pharmaceuticals, Inc. | Results Astex Pharmaceuticals Announces Publication of Key Clinical Data for Guadecitabine (SGI-110) in The Lancet Oncology astx.com ↗
Importantly, potent dose-related DNA demethylation is associated with clinical responses in patients treated with guadecitabine, with responders showing significantly more demethylation than non-responders. |
| 2014-06-16 | Astex Pharmaceuticals, Inc. | Results Astex Pharmaceuticals Presents Final Results of Phase 2 Study of SGI-110 in Treatment Naive Elderly Acute Myeloid Leukaemia at the European Hematology Association Meeting astx.com ↗
The primary endpoint of Overall Complete Remission (CR or CR with incomplete normal count recovery (CRi)) was achieved in 28 of 51 patients (55%). |
| 2013-09-30 | Astex Pharmaceuticals, Inc. | Results Astex Pharmaceuticals Announces Oral Presentation of SGI-110 AML Data at the European Cancer Congress. astx.com ↗
The presentation showed that of the 50 heavily pre -treated Phase 1 AML patients with LINE-1 DNA methylation data, there were 5 Complete Responses, or 10% (2 CRs, 1 CRp, and 2 CRi). |
| 2013-08-28 | Astex Pharmaceuticals, Inc. | Results Astex Pharmaceuticals Announces Topline Results of SGI-110 AML Phase 2 Study. astx.com ↗
Astex Pharmaceuticals, Inc. (Nasdaq:ASTX) today announced topline results from the ongoing phase 2 of SGI -110 in patients with AML and MDS. |
| 2012-12-10 | Astex Pharmaceuticals, Inc. | Results Astex Pharmaceuticals Announces Results From Dose Escalation Part of SGI-110 Phase 1/2 MDS and AML Study in an Oral Presentation at ASH astx.com ↗
Of the 17 heavily pretreated relapsed/refractory AML patients who were given therapeutic doses of SGI -110 and achieved adequate hypomethylation, 5 major responses were observed. |
| 2012-11-20 | Astex Pharmaceuticals, Inc. | Results Astex Pharmaceuticals Announces Oral Presentation of SGI-110 Results From Phase 1/2 MDS and AML Study at ASH astx.com ↗
clinical responses were observed in this heavily pretreated population which seem to correlate with the extent of LINE -1 hypomethylation. |
| 2012-04-03 | Astex Pharmaceuticals, Inc. | Results Astex Pharmaceuticals Announces Subcutaneous SGI-110 Interim Phase 1/2 MDS and AML Data Presentation at AACR astx.com ↗
The data was presented at an oral session at the American Association for Cancer Research (AACR) 2012 Annual Meeting in Chicago, IL and was featured in a joint AACR-Stand Up To Cancer (SU2C) media forum. |
| 2010-12-03 | Astex Pharmaceuticals, Inc. | Results SuperGen Announces Presentation of SGI-110 Preclinical Data at American Society of Hematology astx.com ↗
SGI-110 demonstrates sustained hypomethylation with less frequent dosing |
All press releases naming this drug 20 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 36 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Guadecitabine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04340843 ↗ |
| Known as | Guadecitabina | ChEMBL registry synonym — accepted as the source's own label CHEMBL3544916 ↗ |
| Known as | guadecitabine (SGI-110) | “guadecitabine (SGI-110)” NCT04250246 ↗ |
| Known as | GUADECITABINE SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL3544916 ↗ |
| Known as | S110 sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL3544916 ↗ |
| Known as | SGI-110 | “A Phase Ib Study of Guadecitabine (SGI-110) and Durvalumab (MEDI 4736) in Patients With Advanced Hepatocellular Carcinoma, Pancreatic Adenocarcinoma, and...” NCT03257761 ↗14“Guadecitabine (SGI-110) is a novel hypomethylating dinucleotide of Decitabine and deoxyguanosine resistant to degradation by cytidine deaminase.” NCT03454984 ↗ “Study of the Hypomethylating Drug Guadecitabine (SGI-110) Plus Cisplatin in Relapsed Refractory Germ Cell Tumors” NCT02429466 ↗ “Guadecitabine (SGI-110)/ASTX727 a Second Generation Hypo-Methylating Agent” NCT02998567 ↗ “SGI-110 (guadecitabine)” NCT02348489 ↗ |
| Known as | Sgi-110 free acid | ChEMBL registry synonym — accepted as the source's own label CHEMBL3544916 ↗ |
| Known as | SGI-110 sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL3544916 ↗ |
| Action | Inhibit | “Guadecitabine is a novel DNA methyltransferase (DNMT) inhibitor” PMID 31331399 ↗ Jul 2019 |
| Modality | Oligonucleotide (other) | “Guadecitabine (SGI-110) is a novel hypomethylating dinucleotide of decitabine and deoxyguanosine resistant to degradation by cytidine deaminase.” PMID 26296954 ↗ Aug 2015 |
| Route | Subcutaneous | “subcutaneously given guadecitabine” PMID 26296954 ↗ Aug 2015 |