Drugs / Picankibart
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | picankibart | psoriasis | 2024-09-26 | “the New Drug Application (NDA) for picankibart injection, a recombinant anti-interleukin 23p19 subunit (IL-23p19) antibody, has been accepted by the Center for Drug Evaluation...” innoventbio.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07295509 | Dec 2025 → Dec 2029 expected | psoriatic arthritis | Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06945107 | May 2025 → Jun 2026 overdue | psoriasis | Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. | Active not recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07552454 | Apr 2026 → Oct 2027 expected | palmoplantar pustulosis | Xijing Hospital | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2025-12-09 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces PECONDLE® (Picankibart Injection) Phase 3 Study (CLEAR-2) Meets Endpoints, Delivering Superior Long-Term Management Solution for Moderate-to-Severe Psoriasis innoventbio.com ↗ |
| 2025-11-28 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory China's First Domestic IL-23p19 Monoclonal Antibody: Innovent's PECONDLE® (Picankibart Injection) Received NMPA Approval innoventbio.com ↗
PECONDLE® (picankibart injection) has received approval from China's National Medical Products Administration (NMPA) for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systematic therapy. |
| 2024-10-29 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces Results of a Phase 2 Study of Picankibart (Anti-IL-23p19 Antibody) in Plaque Psoriasis, Showing Robust Efficacy in Patients with Prior Inadequate Response to IL-17 Biologics innoventbio.com ↗
The study demonstrated that after 16-week of treatment with picankibart, the majority of patients (64.6%,42/65) who had inadequate response to previous biologic agents (mainly those targeting IL-17), achieved skin clearance or near clearance with a sPGA of 0 or 1. |
| 2024-10-17 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces Phase 2 Clinical Study of Picankibart (IBI112) in Chinese Patients with Ulcerative Colitis Met Primary Endpoint innoventbio.com ↗
The primary and secondary endpoints were met: |
| 2024-09-26 | Innovent Biologics (Suzhou) Co. Ltd. | Regulatory Innovent Announces NMPA Acceptance of NDA for Picankibart (Anti-IL-23p19 Antibody) for Treating Moderate to Severe Plaque Psoriasis innoventbio.com ↗
This NDA acceptance is based on positive results from the Phase 3 registrational clinical study CLEAR-1 (NCT05645627) in Chinese patients with moderate to severe plaque psoriasis. |
| 2024-05-28 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces Picankibart (IBI112) Achieved Primary Endpoints in a Phase 3 Clinical Trial in Treating Moderate to Severe Plaque Psoriasis, and Plans to Submit NDA to the NMPA innoventbio.com ↗
CLEAR-1 is global the first Phase 3 registration study in IL-23p19 class that reported over 80% of subjects achieved PASI 90 after 16 weeks of treatment in psoriasis patients. |
| 2022-08-10 | Innovent Biologics (Suzhou) Co. Ltd. | Results Innovent Announces Phase 2 Clinical Study of Picankibart (IBI112) in Chinese Patients with Moderate-to-severe Plaque Psoriasis Met Primary Endpoint innoventbio.com ↗ |
All press releases naming this drug 11 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Picankibart | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07295509 ↗ |
| Known as | IBI112 | “This is a multicenter, randomized, double-blind, placebo-controlled Phase II/III clinical trial evaluating the efficacy and safety of picankibart (IBI112) in patients with...” NCT07295509 ↗ |
| Modality | Monoclonal antibody | — CHEMBL5314763 ↗ |
| Route | Subcutaneous | “receive picankibart 200mg SC” NCT06945107 ↗ |