Drugs / Imsidolimab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | generalized pustular psoriasis | 2025-12-15 | “today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imsidolimab” vandapharma.com ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 26 trials · 1 met primary · 3 missed | ||||||
| Phase 2 | NCT04856930 | Jul 2021 → Jul 2022 | hidradenitis suppurativa | Vanda Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT04856917 | May 2021 → Feb 2022 | acne | Vanda Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT04697069 | May → Dec 2021 | acneiform dermatitis | Vanda Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT04697056 | Jan → Nov 2021 | ichthyosis | Vanda Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT03633396 | May 2019 → Apr 2021 | palmoplantar pustulosis | Vanda Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT03619902 | Jan 2019 → Jan 2021 | generalized pustular psoriasis | Vanda Pharmaceuticals | Completed | Met primary |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT05366855 | Apr 2022 → Jul 2024 | generalized pustular psoriasis | Vanda Pharmaceuticals | Terminated | No outcome recorded |
| Phase 3 | NCT05352893 | Apr 2022 → Aug 2023 | generalized pustular psoriasis | Vanda Pharmaceuticals | Completed | Met primary |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-08-24 | Vanda Pharmaceuticals | Regulatory Vanda Pharmaceuticals Granted Orphan Designation for Imsidolimab for the Treatment of Generalized Pustular Psoriasis by the European Commission vandapharma.com ↗ |
| 2026-07-16 | Vanda Pharmaceuticals | Regulatory Vanda Pharmaceuticals Announces EMA Positive Opinion for Orphan Drug Designation of Imsidolimab for Generalized Pustular Psoriasis - A Milestone Recognition of GPP as a Distinct Rare Disease in Europe vandapharma.com ↗
This marks the first time the EMA has granted orphan drug designation recognition for a drug to treat GPP in the European Union (EU). |
| 2026-05-27 | Vanda Pharmaceuticals | Regulatory Vanda Pharmaceuticals Announces Orphan Drug Designation in Japan for Imsidolimab in Generalized Pustular Psoriasis vandapharma.com ↗
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted orphan drug designation to imsidolimab, a high‑affinity humanized immunoglobulin G4 (IgG4) monoclonal antibody, for the treatment of generalized pustular psoriasis (GPP). |
| 2026-02-25 | Vanda Pharmaceuticals | Regulatory Vanda Pharmaceuticals Announces FDA Acceptance of Biologics License Application Filing for Imsidolimab for the Treatment of Generalized Pustular Psoriasis vandapharma.com ↗ |
| 2025-12-15 | Vanda Pharmaceuticals | Regulatory Vanda Announces Submission of Biologics License Application to the FDA for Imsidolimab for the Treatment of Generalized Pustular Psoriasis vandapharma.com ↗
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imsidolimab, a novel IgG4 IL-36 receptor antagonist, to treat generalized pustular psoriasis (GPP). |
| 2022-03-14 | AnaptysBio, Inc. | Results AnaptysBio Reports Imsidolimab ACORN Phase 2 Clinical Trial Data in Moderate-to-Severe Acne anaptysbio.com ↗
AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, today announced that top-line data from its Phase 2 clinical trial of imsidolimab for the treatment of moderate-to-severe acne, also known as the ACORN trial, did not demonstrate efficacy over placebo on primary or secondary endpoints. |
| 2021-10-02 | AnaptysBio, Inc. | Results AnaptysBio Presents Updated Data From Imsidolimab Phase 2 GALLOP Trial in Generalized Pustular Psoriasis anaptysbio.com ↗
Imsidolimab demonstrated rapid and sustained efficacy with 6 of 8 (75%) generalized pustular psoriasis (GPP) patients achieving the primary endpoint at week 4 and week 16 |
| 2021-03-08 | AnaptysBio, Inc. | Results AnaptysBio Reports Imsidolimab POPLAR Phase 2 Clinical Trial in Moderate-to-Severe Palmoplantar Pustulosis (PPP) Did Not Meet Primary Endpoint anaptysbio.com ↗
today announced that top-line data from its Phase 2 clinical trial of imsidolimab for the treatment of moderate-to-severe palmoplantar pustulosis (PPP), also known as the POPLAR trial, failed to meet its primary endpoint. |
| 2020-10-13 | AnaptysBio, Inc. | Results AnaptysBio Reports Positive Topline Data from GALLOP Phase 2 Clinical Trial of Imsidolimab in Moderate-to-Severe Generalized Pustular Psoriasis (GPP) anaptysbio.com ↗
AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, today announced positive topline data from an interim analysis of its Phase 2 clinical trial of imsidolimab for the treatment of moderate-to-severe generalized pustular psoriasis (GPP), also known as the GALLOP trial. |
| 2020-07-08 | AnaptysBio, Inc. | Regulatory AnaptysBio Announces Orphan Drug Designation of Imsidolimab For Treatment of Generalized Pustular Psoriasis anaptysbio.com ↗
“Receiving orphan drug designation for the treatment of GPP is an important milestone for our wholly-owned imsidolimab program,” said Hamza Suria , president and chief executive officer of AnaptysBio . |
| 2018-05-29 | AnaptysBio, Inc. | Results AnaptysBio Presents Updated ANB020 and ANB019 Clinical Data at the 2018 EAACI Congress anaptysbio.com ↗
Favorable safety, pharmacokinetics and pharmacodynamics observed in ANB019 healthy volunteer single and multiple ascending dose Phase 1 trial |
All press releases naming this drug 16 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Imsidolimab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04856917 ↗ |
| Known as | ANB019 | “A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in Adults With Generalized Pustular Psoriasis” NCT03619902 ↗ |
| Action | Inhibit | “antagonizes IL-36 signaling.” PMID 42047557 ↗ Apr 2026 |
| Modality | Monoclonal antibody | “Humanized monoclonal antibody” NCT03619902 ↗ |
| Route | Intravenous | “750 mg intravenously (IV) on Day 1” NCT03619902 ↗ |