Drugs / Gusacitinib
Gusacitinib
also known as
ASN002 · ASN-002 HYDROCHLORIDE · EN-3351 · EN-3351 HYDROCHLORIDE · GUSACITINIB HYDROCHLORIDE
Small molecule targets IFNG, SYK via inhibition
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT03641573 | Oct 2018 | — | Asana BioSciences | Completed | No outcome recorded |
| Phase 1 | NCT03139981 | Apr → Nov 2017 | atopic eczema | Asana BioSciences | Completed | No outcome recorded |
| Phase 1 | NCT02853643 | Jul → Nov 2016 | — | Asana BioSciences | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT03208296 | Dec 2017 → Dec 2024 | basal cell carcinoma | Ascend Biopharmaceuticals Ltd | Suspended | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT02550678 | Sep 2015 → Nov 2017 | nevoid basal cell carcinoma syndrome, nodular basal cell carcinoma | Ascend Biopharmaceuticals Ltd | Completed | No outcome recorded |
| Phase 1/2 | NCT02440685 | May 2015 → Jun 2018 | B-cell chronic lymphocytic leukemia, diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma +2 | Asana BioSciences | Terminated | No outcome recorded Stop: Business |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT04416516 | Jul 2020 → Feb 2024 | basal cell carcinoma, nevoid basal cell carcinoma syndrome | Ascend Biopharmaceuticals Ltd | Completed | No outcome recorded |
| Phase 2 | NCT03728504 | Jan 2019 → Apr 2020 | hand dermatosis | Asana BioSciences | Completed | Met primary |
| Phase 2 | NCT03654755 | Sep 2018 → Oct 2019 | atopic eczema | Asana BioSciences | Terminated | No outcome recorded |
| Phase 2 | NCT03531957 | Jul 2018 → Jul 2019 | atopic eczema | Asana BioSciences | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT06238531 Comparator | Jan 2025 | systemic lupus erythematosus | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2020-10-20 | Asana BioSciences | Results Asana BioSciences to Present Positive Results from Phase 2b Study of Oral JAK/SYK Inhibitor Gusacitinib in Patients with Chronic Hand Eczema in the Late-Breaking News Session at the EADV Virtual Congress asanabio.com ↗
Gusacitinib achieved rapid, dose-dependent, clinically meaningful, and statistically significant improvement relative to placebo in both the primary and key secondary endpoints of efficacy as early as 2 weeks and the effects were sustained for the duration of the study. |
| 2020-06-02 | Asana BioSciences | Results Asana BioSciences Announces Positive Topline Results from Phase 2b Study of Oral JAK/SYK Inhibitor Gusacitinib (ASN002) in Patients with Chronic Hand Eczema: Rapid and Significant Improvement Demonstrated asanabio.com ↗
The topline results show that gusacitinib achieved a dose-dependent, clinically meaningful, and statistically significant improvement relative to placebo in both the primary and key secondary endpoints of efficacy. |
| 2020-06-01 | Asana BioSciences | Results Asana BioSciences’ JAK/SYK Inhibitor Performs Well in Phase 2b Study of Hand Eczema asanabio.com ↗
Asana BioSciences, a clinical stage biopharmaceutical company, today announced that ASN002, its oral once daily dual JAK/SYK inhibitor, has achieved clinical efficacy in a proof of concept study in patients with moderate-to-severe atopic dermatitis. |
| 2019-02-18 | Asana BioSciences | Results Asana BioSciences to Present Correlation Between Microbiome Changes and Clinical Efficacy With JAK/SYK Inhibitor ASN002 in the Late-Breaking News Session at the American Academy of Dermatology (AAD) Annual Congress asanabio.com ↗
Asana BioSciences, a clinical stage biopharmaceutical company, announced that it will present ASN002 data demonstrating changes in skin microbiome and correlation with clinical efficacy in patients with moderate-to-severe atopic dermatitis. |
| 2018-12-10 | Asana BioSciences | Regulatory U.S. FDA Grants Fast Track Designation to Asana BioSciences’ Oral Dual JAK-SYK Inhibitor, ASN002, for the Treatment of Atopic Dermatitis asanabio.com ↗
We are pleased that the FDA has granted Fast Track designation to ASN002 . |
| 2018-09-10 | Asana BioSciences | Results Asana BioSciences to Present Late-Breaking Clinical and Biomarker Data for Its JAK/SYK Inhibitor ASN002 at the European Academy of Dermatology and Venereology (EADV) Annual Congress asanabio.com ↗
Asana BioSciences, a clinical stage biopharmaceutical company, announced that it will present ASN002 data demonstrating improvements in skin pathology, disease related genes and inflammation biomarkers, correlating with clinical efficacy, in patients with moderate-to-severe atopic dermatitis. |
| 2018-05-08 | Asana BioSciences | Results Asana BioSciences to Present Positive Clinical Efficacy and Skin Biomarker Data in Atopic Dermatitis Patients Treated with Its Novel Oral JAK/SYK Inhibitor, ASN002, at the International Investigative Dermatology Meeting asanabio.com ↗
ASN002 a dual oral inhibitor of JAK/SYK signaling improves clinical outcomes and associated cutaneous inflammation in moderate-to-severe atopic dermatitis patients. |
All press releases naming this drug 12 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Gusacitinib | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06238531 ↗ |
| Known as | ASN-002 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594275 ↗ |
| Known as | ASN002 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03139981 ↗ |
| Known as | EN-3351 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594275 ↗ |
| Known as | EN-3351 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594275 ↗ |
| Known as | GUSACITINIB HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594275 ↗ |
| Action | Inhibit | “Tyrosine-protein kinase SYK inhibitor” CHEMBL4594275 ↗ |
| Action | Restore | “The infected cells are able to transcribe and translate the IFNγ DNA” NCT03208296 ↗ |
| Modality | Small molecule | — CHEMBL4594275 ↗ |
| Route | Other | “protocol defined dose of ASN-002 as intra-tumoral injections” NCT02550678 ↗ |
| Target | IFNG | “This rAd vector delivers the gene of interest, in the case of ASN-002 the human IFNγ gene, into target cells.” NCT04416516 ↗ |
| Target | SYK | “Tyrosine-protein kinase SYK inhibitor” CHEMBL4594275 ↗ |