FDA approves TRYNGOLZA (olezarsen) for severe hypertriglyceridemia
The FDA approved Ionis’ TRYNGOLZA (olezarsen) for Severe hypertriglyceridemia (sHTG) on Jun 24, 2026. The company can now sell it in that market.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Ionis Pharmaceuticals, Inc. IONS
- Drug
- TRYNGOLZA (olezarsen)
- For
- Severe hypertriglyceridemia (sHTG)
- Stage
- Regulatory (FDA approval)
- When
- Jun 24, 2026
- Source note
- FDA approved TRYNGOLZA (olezarsen) as an adjunct to diet to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia, the first and only therapy indicated for pancreatitis risk reduction in sHTG. The approval, based on the Phase 3 CORE and CORE2 studies, is Ionis' first independent launch in a prevalent condition.
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- Checked by a person when it was added
- Source: sec.gov ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- IONS headlines on this site
Ionis expects to report results from its Phase 3 study of Pelacarsen for Elevated Lp(a) / cardiovascular risk reduction in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
More details
- Entry
- HORIZON Phase 3 Lp(a) cardiovascular outcomes results for pelacarsen · Clinical trial results (readout / topline data)
- Drug
- Pelacarsen
- For
- Elevated Lp(a) / cardiovascular risk reduction
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Ionis Q2 2026 earnings release: Novartis-run HORIZON outcomes trial results anticipated in H2 2026 — the first CVOT readout for an Lp(a)-lowering therapy; major royalty/milestone driver for Ionis.
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- Checked by a person when it was added
- Verify it
- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- IONS headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Ionis expects European regulators to decide on TRYNGOLZA (olezarsen) for Severe hypertriglyceridemia during 2027 (no exact date yet). An approval lets the company start selling it in that market.
More details
- Entry
- Potential EU approval/launch of olezarsen for sHTG · Regulatory approval
- Drug
- TRYNGOLZA (olezarsen)
- For
- Severe hypertriglyceridemia
- Stage
- EU MAA (indication extension) under review
- When
- 2027 · the company gave a window, not a day
- Source note
- Q2 2026 earnings PR (Jul 29, 2026): sHTG indication extension for TRYNGOLZA is under EMA review with a potential 2027 launch; no CHMP/EC date given.
- Checked
- Checked by a person when it was added
- Verify it
- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- IONS headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page