Drugs / RC28-E
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03777254 | Jan → Aug 2019 | wet macular degeneration | RemeGen Co., Ltd. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04270669 | Apr 2020 → Oct 2021 | wet macular degeneration | RemeGen Co., Ltd. | Completed | No outcome recorded |
| Phase 22 trials · 1 missed | ||||||
| Phase 2 | NCT04782128 | May 2021 → May 2024 | diabetic retinopathy | RemeGen Co., Ltd. | Unknown | No outcome recorded |
| Phase 2 | NCT04782115 | Mar 2021 → Jul 2023 | diabetic macular edema | RemeGen Co., Ltd. | Completed | Missed primary |
| Phase 32 trials | ||||||
| Phase 3 | NCT05885503 | Jun 2023 → Jun 2026 | diabetic macular edema | RemeGen Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT05727397 | Mar 2023 → Nov 2025 | wet macular degeneration | RemeGen Co., Ltd. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-09-30 | Santen Gmbh | Regulatory Santen and RemeGen Announce Biologic License Application (BLA) Acceptance for RC28-E Intravitreal Injection in Diabetic Macular Edema in China santen.com ↗
Santen Pharmaceutical Co., Ltd. (hereinafter Santen), and RemeGen Co., Ltd. (hereinafter RemeGen) jointly announced that the Biologic License Application (BLA) for RC28-E intravitreal injection, a bi-specific fusion protein drug targeting vascular endothelial growth factor (VEGF) and fibroblast growth factor (FGF), has been officially accepted by China’s Center for Drug Evaluation (CDE) for the treatment of patients with diabetic macular edema (DME). |
| 2025-05-08 | RemeGen Co., Ltd. | Results Patients’ Visual Acuity Effectively Improved! Results Unveiled for the Phase II Clinical Study on RC28-E in Treating Diabetic Macular Edema | ARVO 2025 remegen.com ↗
The results showed that RC28-E could improve patients’ best corrected visual acuity (BCVA), reduce central subfield thickness (CST), effectively relieving macular edema. |
| 2024-07-25 | RemeGen Co., Ltd. | Results Study Results of RemeGen’s RC28-E Debut in Top Ophthalmological Journal remegen.com ↗
At Week 48, the best corrected visual acuity (BCVA) and central subfield thickness (CST) registered significant improvement after 1-year treatment in the RC28-E 0.5, 1.0 and 2.0 mg groups. |
All press releases naming this drug 5 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RC28-E | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03777254 ↗ |
| Action | Inhibit | “can block vascular endothelial growth factor (VEGFA), platelet-derived growth factor (PDGF), and fibroblast growth factor-2 (FGF-2) simultaneously” PMID 31652997 ↗ Oct 2019 |
| Modality | Protein / enzyme biologic | “RC28-E is a novel recombinant dual decoy receptor lgG1 Fc-fusion protein” PMID 31652997 ↗ Oct 2019 |
| Route | Intravitreal | “single intravitreal injections of RC28-E” NCT03777254 ↗ |
| Target | VEGFA | “block vascular endothelial growth factor (VEGFA)” PMID 31652997 ↗ Oct 2019 |