Drugs / Icosabutate
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT03577275 | Jun → Sep 2018 | hyperlipidemia | NorthSea Therapeutics B.V. | Completed | No outcome recorded |
| Phase 1 | NCT02364635 | Feb → Aug 2015 | — | Pronova BioPharma | Completed | No outcome recorded |
| Phase 1 | NCT02367937 | Aug → Oct 2014 | — | Pronova BioPharma | Completed | No outcome recorded |
| Phase 1 | NCT02373176 | Jul → Sep 2014 | — | Pronova BioPharma | Completed | No outcome recorded |
| Phase 23 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT04052516 | Jul 2019 → Feb 2022 | metabolic dysfunction-associated steatohepatitis | NorthSea Therapeutics B.V. | Completed | Missed primary |
| Phase 2 | NCT01972178 | Nov 2013 → Jul 2014 | hyperlipidemia | Pronova BioPharma | Terminated | No outcome recorded |
| Phase 2 | NCT01893515 | Jul 2013 → Jul 2014 | hyperlipidemia | Pronova BioPharma | Completed | Met primary |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2025-03-06 | NorthSea Therapeutics B.V. | Results NorthSea Therapeutics Announces Publication of Positive Results from Phase 2b ICONA Clinical Trial of Icosabutate in Biopsy-Confirmed F1-F3 MASH in Journal of Hepatology northseatherapeutics.com ↗
NorthSea Therapeutics B.V. (‘NST’, or the ‘Company’), a private, late-stage clinical biotechnology company developing novel strategies to treat metabolic, cholestatic, and fibrotic diseases, today announced that results from the Phase 2b ICONA clinical trial of icosabutate in biopsy-confirmed F1-F3 metabolic dysfunction-associated steatohepatitis (MASH) were published in the Journal of Hepatology. |
| 2023-11-13 | NorthSea Therapeutics B.V. | Results NorthSea Therapeutics to present ICONA Phase 2b data as an oral late-breaker session at the 2023 AASLD Liver Meeting northseatherapeutics.com ↗
An increase in the proportion of patients achieving NASH resolution without worsening in fibrosis and a ≥2-point decrease in NAS was seen in the 600mg Icosabutate treated arm vs placebo (25.8% vs.11.9%, p=0.03), although the less stringent primary endpoint (not including NAS score) did not reach statistical significance in the overall study population. |
| 2021-11-16 | NorthSea Therapeutics B.V. | Results Icosabutate latest phase 2b interim data show significant decreases in NASH and fibrosis biomarkers independent of fibrosis stage and disease severity northseatherapeutics.com ↗
Significant decreases in key markers of inflammation and fibrogenesis were comparable or of greater magnitude in patients with stage 2/3 fibrosis vs the overall population after 16 weeks in the ICONA trial |
| 2021-01-08 | NorthSea Therapeutics B.V. | Results Positive Phase 2b ICONA interim results for icosabutate in NASH patients northseatherapeutics.com ↗
The interim analysis of secondary endpoints from the first 90 patients treated for 16 weeks has been completed and shows good efficacy and positive safety. |
| 2018-11-09 | NorthSea Therapeutics B.V. | Results Icosabutate latest data shows direct and potent anti-fibrotic effect in both differentiated rodent NASH models and human stellate cells northseatherapeutics.com ↗
In a biopsy-confirmed fibrotic ob/ob NASH mouse model, icosabutate reduced hepatic fibrosis in association with a 45% decrease in myofibroblast content in pre- versus post-treatment liver biopsies |
| 2018-04-12 | NorthSea Therapeutics B.V. | Results Potential of icosabutate as a novel approach to the treatment of NASH highlighted in late-breaker at The International Liver CongressTM 2018 northseatherapeutics.com ↗
Clinical phase 2 data study demonstrated normalisation of elevated baseline liver enzymes in dyslipidemic patients treated with icosabutate 600mg once daily for 12 weeks |
All press releases naming this drug 8 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | icosabutate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02364635 ↗ |
| Known as | Icosabutato | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707220 ↗ |
| Known as | NST-4016 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03577275 ↗ |
| Known as | PRB-01022 | “PRB-01022 (icosabutate) (unchanged drug)” NCT02373176 ↗ |
| Known as | PRC-4016 | “[14C]PRC-4016 (Icosabutate)” NCT02373176 ↗ |
| Action | Activate | “icosabutate, a FFAR1/FFAR4 agonist” PMID 39938653 ↗ Feb 2025 |
| Modality | Small molecule | — CHEMBL3707220 ↗ |
| Route | Oral | “PRC-4016, oral administration once daily, capsule” NCT01893515 ↗ |
| Target | FFAR1 | “icosabutate, a FFAR1/FFAR4 agonist” PMID 39938653 ↗ Feb 2025 |
| Target | FFAR4 | “icosabutate, a FFAR1/FFAR4 agonist” PMID 39938653 ↗ Feb 2025 |