Drugs / CT-P43
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04428814 | Aug 2020 → Feb 2021 | — | Celltrion | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT04673786 | Jan → Aug 2021 | psoriasis | Celltrion | Completed | Met primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT06951828 Comparator | May → Nov 2025 | — | Celltrion | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2025-12-18 | Celltrion | Regulatory Celltrion receives positive CHMP Opinion for SteQeyma™ (ustekinumab biosimilar) autoinjector celltrion.com ↗
SteQeyma™ 45mg and 90mg solution for injection via autoinjector (pre-filled pen) receives positive CHMP opinion, which will facilitate subcutaneous administration in patients with plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease (CD) |
| 2025-06-16 | Celltrion | Regulatory Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA® (ustekinumab-stba), expanding dosing options for pediatric patients celltrion.com ↗
Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), in a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection. |
| 2024-12-18 | Celltrion | Regulatory U.S. FDA approves Celltrion's STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab) celltrion.com ↗
STEQEYMA (CT-P43) is approved for both adult and pediatric patients with plaque psoriasis (PsO) and active psoriatic arthritis (PsA) as well as adults with Crohn's disease (CD) and ulcerative colitis (UC) |
| 2024-08-26 | Celltrion | Regulatory European Commission approves Celltrion’s SteQeyma® (CT-P43), a biosimilar to Stelara® (ustekinumab), for the treatment of multiple chronic inflammatory diseases celltrion.com ↗
Celltrion today announced that the European Commission (EC) has approved the use of SteQeyma® (CT-P43), an ustekinumab biosimilar referencing Stelara®, for the treatment of multiple chronic inflammatory diseases. |
| 2024-02-05 | RANI Therapeutics | Results Rani Therapeutics Announces Positive Topline Results from Phase 1 Study of an Oral Anti-Interleukin 12/23 Antibody (RT-111) ranitherapeutics.com ↗
Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced positive topline results from its Phase 1 clinical study of RT-111, a RaniPill® capsule containing an ustekinumab biosimilar, CT-P43. |
All press releases naming this drug 6 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CT-P43 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04673786 ↗ |
| Modality | Protein / enzyme biologic | “CT-P43 is being developed as a proposed biosimilar of Stelara (ustekinumab).” NCT04428814 ↗ |
| Route | Subcutaneous | “CT-P43, 45 mg in 0.5 ml, a single subcutaneous (SC) injection via auto-injector (AI)” NCT06951828 ↗ |