Drugs / aganirsen
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07411755 | Mar → Sep 2026 overdue | atopic eczema | Jiangsu Genscend Biopharmaceutical Co., Ltd | Recruiting | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02947867 | Jan 2017 → Jun 2019 | central retinal vein occlusion, neovascular glaucoma | Gene Signal SAS | Unknown | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07386743 | Feb 2026 → Apr 2027 expected | atopic eczema | Jiangsu Genscend Biopharmaceutical Co., Ltd | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2026-02-01 | Jiangsu Genscend Biopharmaceutical Co., Ltd | Regulatory CHMP Clears Path for GS101: Single‑Dose PK Study and Immunogenicity Assessment Sufficient for MAA genscend.com ↗
In February 2026, the EMA CHMP adopted positive scientific advice confirming that a tailored clinical development program without a dedicated comparative efficacy study may be acceptable for GS101. |
| 2026-01-13 | Jiangsu Genscend Biopharmaceutical Co., Ltd | Regulatory Update on GS101 as of January 13, 2026 genscend.com ↗
The company announces that the Investigational New Drug application for its self-developed dupilumab biosimilar, GS101, has received implicit approval from the Center for Drug Evaluation of the National Medical Products Administration. |
| 2025-11-01 | Jiangsu Genscend Biopharmaceutical Co., Ltd | Regulatory The IND application for Project GS101 was accepted by the CDE genscend.com ↗
The IND application for a Dupixent biosimilar (Project code:GS101) has been accepted, with acceptance number: CXSL2500955. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-03-01 | Jiangsu Genscend Biopharmaceutical Co., Ltd | GS101 Granted FDA Positive Feedback: Single-Dose PK Study Supports 351(k) Filing genscend.com ↗ |
| 2026-02-01 | Jiangsu Genscend Biopharmaceutical Co., Ltd | CHMP Clears Path for GS101: Single‑Dose PK Study and Immunogenicity Assessment Sufficient for MAA genscend.com ↗ |
| 2026-01-13 | Jiangsu Genscend Biopharmaceutical Co., Ltd | Update on GS101 as of January 13, 2026 genscend.com ↗ |
| 2025-11-01 | Jiangsu Genscend Biopharmaceutical Co., Ltd | The IND application for Project GS101 was accepted by the CDE genscend.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | aganirsen | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02947867 ↗ |
| Known as | GS101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07411755 ↗ |
| Action | Inhibit | “by blocking insulin receptor substrate-1 (IRS)-1” PMID 28302155 ↗ Mar 2017 |
| Route | Topical | “topical administration” PMID 28302155 ↗ Mar 2017 |
| Target | IRS1 | “by blocking insulin receptor substrate-1 (IRS)-1” PMID 28302155 ↗ Mar 2017 |