Drugs / Acoramidis
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Acoramidis

also known as AG10 · ALXN2060

targets TTR

Developed for
amyloidosis · cardiomyopathy · hereditary amyloidosis · polyneuropathy · familial amyloid neuropathy
Investigated by
Eidos Therapeutics, a BridgeBio company · Alexion Pharmaceuticals, Inc. · Bayer · Celerion

Regulatory milestones approvals, filings & regulatory actions · 5 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed ATTRV122I amyloidosis 3 milestones
Filed EU (EMA) — ATTRV122I amyloidosis 2024-04-07

“The Company has also filed a Marketing Authorization Application for acoramidis with the EMA, which has been accepted for review.” bridgebio.com ↗

“a Marketing Authorization Application (MAA) for acoramidis has been accepted by the European Medicines Agency (EMA)” bridgebio.com ↗

“Marketing authorization application (MAA) with the European Medicines Agency (EMA) was filed in January 2024” bayer.com ↗

“The EMA accepted the Company’s MAA for acoramidis for review, with an expected approval in 2025” bridgebio.com ↗

Filed US (FDA) — ATTRV122I amyloidosis 2024-04-07

“Based on the positive results from ATTRibute-CM, BridgeBio submitted an NDA to the U.S.” bridgebio.com ↗

Filed US (FDA) — ATTRV122I amyloidosis 2023-12-05

“today announced that it has submitted an NDA for acoramidis to the U.S. FDA for the treatment of ATTR-CM” bridgebio.com ↗

Approved Indication not stated 2 milestones
Approved EU (EMA) Beyonttra — 2025-02-10 europa.eu ↗
Approved US (FDA) ATTRUBY — 2024-11-22 fda.gov ↗

Trials 11

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT04958135 May → Aug 2021 — Alexion Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT04769479 Mar → Aug 2021 amyloidosis Eidos Therapeutics, a BridgeBio company Completed No outcome recorded
Phase 36 trials · 1 met primary
Phase 3 NCT07116473 Nov 2025 → Nov 2037 expected cardiomyopathy, hereditary amyloidosis, polyneuropathy Eidos Therapeutics, a BridgeBio company Not yet recruiting No outcome recorded
Phase 3 NCT06563895 May 2025 → Oct 2031 expected cardiomyopathy, hereditary amyloidosis, polyneuropathy Eidos Therapeutics, a BridgeBio company Recruiting No outcome recorded
Phase 3 NCT04988386 Oct 2021 → Apr 2028 expected — Eidos Therapeutics, a BridgeBio company Active not recruiting Met primary
Phase 3 NCT04882735 Sep 2021 → Sep 2026 familial amyloid neuropathy Eidos Therapeutics, a BridgeBio company Withdrawn No outcome recorded
Phase 3 NCT04622046 Nov 2020 → Nov 2023 amyloidosis Alexion Pharmaceuticals, Inc. Completed No outcome recorded
Phase 3 NCT03860935 Mar 2019 → May 2023 cardiomyopathy, hereditary amyloidosis Eidos Therapeutics, a BridgeBio company Completed No outcome recorded
Phase 43 trials
Phase 4 NCT07695701 Jul 2026 → Aug 2030 expected amyloidosis Eidos Therapeutics, a BridgeBio company Not yet recruiting No outcome recorded
Phase 4 NCT07298044 Feb 2026 → Jul 2027 expected amyloidosis Bayer Recruiting No outcome recorded
Phase 4 NCT07306949 Oct 2025 → Mar 2028 expected — Alexion Pharmaceuticals, Inc. Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 46

DateIssuerRelease
2026-08-30 Eidos Therapeutics, a BridgeBio company Results Acoramidis Demonstrates Reversal of Cardiac Structural Disease Progression and Functional Decline and Significantly Increases Days Alive and Free from Hospitalization in ATTR-CM bridgebio.com ↗
Acoramidis demonstrated long-term efficacy and safety through 54 months across variant ATTR-CM subgroups, including p.Val142Ile and non-p.Val142Ile.
2026-07-02 Eidos Therapeutics, a BridgeBio company Results Acoramidis Associated with First-Ever Early and Sustained Direct Kidney-Protective Effects in ATTR-CM bridgebio.com ↗
Acoramidis initiation was associated with rapid kidney-protective activity as exhibited in a hemodynamically mediated, reversible eGFR dip and a placebo-corrected 15.5% reduction in UACR by Day 28 (P<0.05), with no kidney-related adverse events observed in these post-hoc analyses
2026-05-11 Eidos Therapeutics, a BridgeBio company Results Acoramidis Continues to Demonstrate Disease-Modifying Effects in ATTR-CM, Reducing sTTR Variability and Outpatient Worsening Heart Failure bridgebio.com ↗
Acoramidis increased sTTR early and significantly reduced intra-individual sTTR variability versus placebo (p<0.001), which is associated with reduced ACM, further reinforcing its differentiated profile in ATTR-CM
2026-05-06 Eidos Therapeutics, a BridgeBio company Regulatory BEYONTTRA™ (acoramidis), the First Near-Complete TTR Stabilizer (≥90%), Approved by ANVISA to Treat ATTR-CM in Brazil bridgebio.com ↗
The approval of Beyonttra in Brazil is based on positive results from the Phase 3 ATTRibute-CM study, in which acoramidis demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date, including:
2026-03-30 Eidos Therapeutics, a BridgeBio company Results Acoramidis Significantly Reduces the Risk of All-Cause and Cardiovascular Mortality in Patients with ATTR-CM through Month 54 bridgebio.com ↗
today presented long-term efficacy and safety data from the ATTRibute-CM open-label extension (OLE) trial, demonstrating sustained clinical benefit of acoramidis through Month 54 in patients with ATTR-CM.
2025-11-08 Eidos Therapeutics, a BridgeBio company Results Acoramidis Significantly Reduces All-cause Mortality in the Overall ATTR-CM Variant and V142I (V122I) Populations bridgebio.com ↗
BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, presented data from the ATTRibute-CM study, showing that acoramidis significantly reduces all-cause mortality (ACM) through Month 42 in the overall variant ATTR-CM population, and specifically in the p.Val142Ile (V142I, V122I) subpopulation.
2025-11-03 Eidos Therapeutics, a BridgeBio company Results BridgeBio to Present Data from the Overall ATTR-CM Variant and V142I (V122I) Populations from ATTRibute-CM at the AHA Scientific Sessions 2025 bridgebio.com ↗
Acoramidis Reduces All-Cause Mortality and First Cardiovascular Hospitalization in Patients with Variant Transthyretin Amyloid Cardiomyopathy: Results from the ATTRibute-CM Study
2025-09-28 Eidos Therapeutics, a BridgeBio company Results Acoramidis Begins to Reduce Cumulative Cardiovascular Outcomes Within the First Month of Treatment in Patients with ATTR-CM bridgebio.com ↗
2025-09-22 Eidos Therapeutics, a BridgeBio company Results BridgeBio to Present Additional Cardiovascular Outcomes Data from ATTRibute-CM at the HFSA Annual Scientific Meeting 2025 bridgebio.com ↗
Continuous Acoramidis Treatment Significantly Reduced Risk of All-cause Mortality and Cardiovascular-related Hospitalization at Month 42, in Patients with Wild-type and Variant Transthyretin Amyloidosis Cardiomyopathy
2025-08-30 Eidos Therapeutics, a BridgeBio company Results Acoramidis Demonstrates Statistically Significant Reduction in Cardiovascular Mortality (CVM) through Month 42 of the ATTRibute-CM Open Label Extension bridgebio.com ↗
BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, presented data from the ATTRibute-CM open label extension (OLE) through Month 42, which demonstrated a statistically significant reduction in CVM in the overall transthyretin amyloid cardiomyopathy (ATTR-CM) population.
2025-05-20 Eidos Therapeutics, a BridgeBio company Results Acoramidis Reduced Incidence of Atrial Fibrillation Events in Patients with ATTR-CM bridgebio.com ↗
The reduction in new-onset atrial fibrillation and AF-related hospitalizations represents an important finding for the ATTR-CM community.
2025-05-19 Eidos Therapeutics, a BridgeBio company Results Early and Sustained Increase in Serum TTR Levels by Acoramidis Independently Predicted Improved Survival in the ATTRibute-CM Study bridgebio.com ↗
The open-label extension data for all ATTRibute-CM participants at Month 42 showed that rapid, sustained TTR stabilization from acoramidis demonstrated statistically significant reductions in ACM and CVH (including urgent outpatient treatment for heart failure exacerbations)

All press releases naming this drug 60 releases

DateIssuerRelease

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 12 sources stand behind the page.

FieldValueCited text
Known as Acoramidis ClinicalTrials.gov intervention name — accepted as the source's own label NCT04882735 ↗
9

NCT06563895 ↗

NCT03860935 ↗

NCT07116473 ↗

NCT07695701 ↗

NCT07298044 ↗

NCT04958135 ↗

NCT07306949 ↗

NCT04988386 ↗

NCT04769479 ↗

Known as AG10 “investigational drug acoramidis (AG10) hydrochloride (HCl) 800mg administered orally twice a day” NCT04882735 ↗
2

“Acoramidis (AG10) oral tablet” NCT07695701 ↗

“Acoramidis (AG10)” NCT07116473 ↗

Known as ALXN2060 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04622046 ↗
Route Oral “oral treatment with ALXN2060” NCT04622046 ↗
Target TTR “Acoramidis is a high-affinity TTR stabilizer that acts to inhibit dissociation of tetrameric TTR” PMID 38197816 ↗ Jan 2024