Drugs / Usnoflast
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | — | 2020-11-03 | “today announced that it has filed the IND application of ZYIL1” zyduslife.com ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04972188 | Jul → Oct 2021 | — | Zydus Lifesciences Limited | Completed | No outcome recorded |
| Phase 1 | NCT04731324 | Dec 2020 → Jun 2021 | — | Zydus Lifesciences Limited | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06398808 | Apr → Nov 2024 | ulcerative colitis | Zydus Lifesciences Limited | Completed | No outcome recorded |
| Phase 2 | NCT05186051 | Jun → Jul 2022 | cryopyrin-associated periodic syndrome | Zydus Lifesciences Limited | Completed | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT07023835 Comparator | Sep 2025 → Mar 2028 expected | amyotrophic lateral sclerosis | Zydus Therapeutics Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05981040 Comparator | Nov 2023 → Jun 2024 | amyotrophic lateral sclerosis | Zydus Lifesciences Limited | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2025-05-28 | Zydus Lifesciences Limited | Regulatory Zydus receives USFDA ‘Fast Track Designation’ for Usnoflast, a novel oral NLRP3 inhibitor, for the treatment of Amyotrophic Lateral Sclerosis (ALS) zyduslife.com ↗
Zydus, a leading, discovery -based, global pharmaceutical company today announced that the USFDA has granted ‘Fast Track Designation ’ to Usnoflast, a novel oral NLRP3 inhibitor, for the treatment of Amyotrophic Lateral Sclerosis (ALS). |
| 2025-01-22 | Zydus Lifesciences Limited | Regulatory Zydus announces USFDA Orphan Drug Designation to Usnoflast for the treatment of Amyotrophic Lateral Sclerosis (ALS) zyduslife.com ↗
Zydus, a leading, discovery-based, global pharmaceutical company today announced that the USFDA has granted Orphan Drug Designation (ODD) to Usnoflast, a novel oral NLRP3 inhibitor, for the treatment of amyotrophic lateral sclerosis (ALS). |
| 2025-01-18 | Zydus Lifesciences Limited | Regulatory Zydus Lifesciences receives approval from USFDA to conduct Phase II(b) clinical trial for Usnoflast, a novel oral NLRP3 inflammasome inhibitor in patients with Amyotrophic Lateral Sclerosis (ALS) zyduslife.com ↗
Zydus, a leading, discovery-based, global pharmaceutical company today announced that it has received approval from USFDA to conduct Phase II(b) clinical trial for Usnoflast, a novel oral NLRP3 inflammasome inhibitor in patients with Amyotrophic Lateral Sclerosis (ALS). |
| 2024-09-10 | Zydus Lifesciences Limited | Results Zydus Lifesciences announces completion of Phase II(a) clinical trial of Usnoflast, a novel oral NLRP3 inflammasome inhibitor in patients with Amyotrophic Lateral Sclerosis (ALS) zyduslife.com ↗
Usnoflast showed favorable trend towards reduction in Neurofilament Light chain (NfL), an established biomarker of neurodegeneration, in the CSF of ALS patient |
| 2024-04-01 | Zydus Lifesciences Limited | Regulatory Zydus Lifesciences receives approval for the name ‘Usnoflast’ as recommended name for ZYIL1 from the WHO International Non-proprietary Names (INN) zyduslife.com ↗
Zydus, a leading discovery-based, global pharmaceutical company, announced today that it has received approval from WHO International Non-proprietary Names (INN) for “Usnoflast” as the recommended name for ZYIL1. |
| 2023-12-16 | Zydus Lifesciences Limited | Regulatory Zydus receives approval from USFDA to initiate Phase II clinical trial of ZYIL1 in patients with Parkinson’s disease zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) a leading discovery -based, global pharmaceutical company, announced today that it has received permission from USFDA, to initiate the Phase II clinical stu dy of NLRP3 inhibitor “ZYIL1” in patients with Parkinson’s disease. |
| 2023-08-25 | Zydus Lifesciences Limited | Results Zydus to present on ZYIL1 at the International Congress of Parkinson’s Disease and Movement Disorders zyduslife.com ↗
ZYIL1 decreased α synuclein expression and improved motor function in non-clinical models of Parkinson’s Disease |
| 2023-03-21 | Zydus Lifesciences Limited | Regulatory Zydus granted Orphan Drug Designation by the USFDA for ZYIL1 in treatment of patients with Cryopyrin Associated Periodic Syndrome (CAPS) zyduslife.com ↗ |
| 2022-09-07 | Zydus Lifesciences Limited | Results Zydus announces positive Phase 2 Proof-of-Concept of NLRP3 inhibitor, ZYIL1 in patients with Cryopyrin Associated Periodic Syndrome (CAPS) zyduslife.com ↗ |
| 2020-12-07 | Zydus Lifesciences Limited | Regulatory Zydus announces Phase I trials of ZYIL1, a novel oral small molecule NLRP3 inflammasome inhibitor zyduslife.com ↗
Zydus, a leading discovery based, global pharmaceutical company today announced that it has received permission to initiate th e Phase 1 clinical trial of ZYIL1, a novel oral small molecule NLRP3 inhibitor candidate. |
| 2020-11-03 | Zydus Lifesciences Limited | Regulatory Zydus announces IND filing of ZYIL1, a novel oral small molecule NLRP3 inflammasome inhibitor zyduslife.com ↗
Zydus, a leading discovery based, global pharmaceutical company today announced that it has filed the IND application of ZYIL1, a novel oral small molecule NLRP3 inhibitor candidate. |
All press releases naming this drug 14 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Usnoflast | “Objective: To assess the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of Usnoflast (ZYIL1) in patients with amyotrophic lateral sclerosis (ALS).” PMID 40511876 ↗ Jun 2025 |
| Known as | ZYIL1 | “Objective: To assess the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of Usnoflast (ZYIL1) in patients with amyotrophic lateral sclerosis (ALS).” PMID 40511876 ↗ Jun 20254“ZYIL1 capsules 25 mg for oral administration + 50 mg placebo” NCT06398808 ↗ |
| Action | Inhibit | “ZYIL1 is a novel oral selective NLRP3 inflammasome inhibitor which prevents NLRP3-induced ASC oligomerization, thus inhibiting NLRP3 inflammasome pathway.” NCT04731324 ↗ |
| Modality | Small molecule | — CHEMBL5314548 ↗ |
| Route | Oral | “Subjects will be administered single oral dose of ZYIL1 on Day 1.” NCT04731324 ↗ |
| Target | NLRP3 | “ZYIL1 is a nucleotide-binding oligomerization domain, leucine rich repeat and pyrin domain-containing 3 (NLRP3) inflammasome inhibitor” PMID 36065092 ↗ Sep 2022 |