A Phase IIb, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate the Efficacy and Safety of Concomitant Use of Eplontersen and ALXN2220 Compared With Eplontersen and Placebo in Adult Participants With Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

The purpose of this randomised, double-blind, placebo-controlled, multicenter study is to evaluate the efficacy and safety of concomitant use of eplontersen and ALXN2220 compared with eplontersen and placebo in adult participants with Transthyretin-mediated amyloid cardiomyopathy (ATTR-CM).

Start Date11 Jun 2026

Sponsor / Collaborator

AstraZeneca PLC

NCT06527755

/ CompletedPhase 1

A Phase 1, Open-Label Study to Assess the Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability of Eplontersen Following Subcutaneous Administration of a Single Dose in Healthy Chinese Volunteers

This is a Phase 1 study to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of eplontersen following single dosing in healthy Chinese participants. The objectives of the study are: to characterize the pharmacokinetic (PK) profiles and the pharmacodynamic (PD) profiles, and to evaluate the safety and tolerability and the immunogenicity of eplontersen following subcutaneous administration of a single 45 mg dose in healthy Chinese participants.

Start Date06 Aug 2024

Sponsor / Collaborator

AstraZeneca PLC

NCT06194825

/ Active, not recruitingPhase 3

A Phase 3, Randomized Study, With Initial 24-week, Double-Blind and Placebo-Controlled Treatment Phase, Followed by An 80-week Open-label Extension Treatment Phase to Evaluate the Effect of Eplontersen on the Transthyretin Reduction and Long-Term Safety in Chinese Participants With Transthyretin Amyloid Cardiomyopathy (EPIC-ATTR)

The purpose of this study is to investigate the effect of eplontersen compared to placebo on the reduction of serum TTR concentration and long-term safety in Chinese participants with hereditary or wild-type transthyretin amyloid cardiomyopathy.

Start Date01 Dec 2023

Sponsor / Collaborator

AstraZeneca PLC

100 Clinical Results associated with Eplontersen

100 Translational Medicine associated with Eplontersen

100 Patents (Medical) associated with Eplontersen

Literatures (Medical) associated with Eplontersen

01 Jun 2026·MUSCLE & NERVE

Eplontersen for Hereditary Transthyretin Amyloidosis With Polyneuropathy: An Exploratory Analysis of Treatment Effect in Male and Female Patients

Article

Author: Markus Weiler ; Jonatan Nåtman ; Barry Reicher ; Maksym Pola ; Morie Gertz ; Jonas Wixner ; Sami Khella ; John L. Berk ; Noel R. Dasgupta ; T. Jesse Kwoh ; Márcia Waddington Cruz ; Yeşim Parman

ABSTRACT:

Introduction/Aims:

Eplontersen is approved in multiple regions for adults with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv‐PN). This exploratory analysis was conducted to evaluate the treatment effect of eplontersen by sex in patients with ATTRv‐PN from the NEURO‐TTRansform trial (NCT04136184).

Methods:

Participants in NEURO‐TTRansform who received ≥ 1 dose of eplontersen were included in this analysis; participants in the inotersen reference group who switched to eplontersen were excluded. Eplontersen was evaluated in the overall patient population and in a subgroup with cardiomyopathy. Change from baseline in the NEURO‐TTRansform primary endpoints of serum transthyretin (TTR) levels to Week 65, modified Neuropathy Impairment Score +7 (mNIS+7) composite score to Week 66, and Norfolk Quality of Life‐Diabetic Neuropathy (Norfolk QoL‐DN) total score to Week 66 were evaluated. A historical placebo group from the NEURO‐TTR trial (NCT01737398) was included as a control.

Results:

The eplontersen group comprised 100 (69.4%) male and 44 (30.6%) female patients. The placebo group comprised 41 (68.3%) male and 19 (31.7%) female patients. For both sexes, treatment with eplontersen decreased serum TTR levels by > 80% (vs. reductions of 3%–13% with placebo), maintained mNIS+7 scores, and improved Norfolk QoL‐DN scores (vs. deterioration with placebo). The treatment effect of eplontersen was similar in male and female patients with cardiomyopathy.

Discussion:

Eplontersen halted neuropathy impairment and improved quality of life versus placebo to a similar degree in both male and female patients with ATTRv‐PN, including those with cardiomyopathy. These findings support the use of eplontersen as an effective treatment for ATTRv‐PN regardless of sex.

01 Jun 2026·Circulation-Heart Failure

Rationale and Design of CARDIO-TTRansform, a Phase 3 Trial of Eplontersen in Transthyretin Amyloid Cardiomyopathy

Article

Author: Solomon, Scott D. ; Yang, Qingqing ; Garcia-Pavia, Pablo ; Tsimikas, Sotirios ; Waddington-Cruz, Márcia ; Tahara, Nobuhiro ; Nativi-Nicolau, Jose ; Gillmore, Julian D. ; Obici, Laura ; Davis, Margot K. ; Viney, Nicholas J. ; Shah, Sanjiv J. ; Kristen, Arnt V. ; Sperry, Brett W. ; Maurer, Mathew S. ; Fontana, Marianna ; Chen, Jersey ; Cappelli, Francesco ; Masri, Ahmad ; Hanna, Mazen ; Falk, Rodney H.

BACKGROUND::

Transthyretin amyloidosis with cardiomyopathy is a progressive, fatal disease characterized by deposition of extracellular misfolded transthyretin (TTR) in the myocardium. Eplontersen is an N-acetylgalactosamine ligand–conjugated antisense oligonucleotide targeting hepatocyte TTR messenger RNA to reduce the production of circulating TTR.

METHODS::

CARDIO-TTRansform is a Phase 3, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of eplontersen in transthyretin amyloidosis with cardiomyopathy. Key inclusion criteria include histological evidence of amyloid deposits or grade 2 to 3 cardiac uptake on cardiac scintigraphy in the absence of plasma cell dyscrasia, New York Heart Association class I–III, and end-diastolic interventricular septum thickness >12 millimeters. Participants were randomized 1:1 to receive eplontersen 45 mg or placebo, administered subcutaneously every 4 weeks for up to 140 weeks, followed by a 20-week post-treatment evaluation period or open-label extension. Participants received locally available standard of care, including unrestricted use of TTR stabilizers. The primary end point is a composite of cardiovascular mortality and recurrent clinical cardiovascular events through 140 weeks. Secondary end points, in order of testing hierarchy, include changes from baseline in 6-minute walk distance and Kansas City Cardiomyopathy Questionnaire overall summary score, recurrent cardiovascular events, all-cause mortality, the primary end point in the patient subgroup receiving stabilizers at baseline, and cardiovascular mortality. Echocardiography was performed in all participants, with cardiovascular magnetic resonance imaging and technetium scintigraphy in a subset.

CONCLUSIONS::

CARDIO-TTRansform is fully enrolled, with 1432 randomized participants who were dosed with study drug or placebo. As the largest transthyretin amyloidosis with cardiomyopathy study to date, it will evaluate whether eplontersen improves cardiovascular outcomes in patients receiving locally available standard of care, including TTR stabilizers.

REGISTRATION::

URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04136171. URL: http://ClinicalTrialsRegister.eu ; Unique identifier: EudraCT number 2019-002835-27.

04 May 2026·Neurodegenerative Disease Management

A review of Eplontersen use in hereditary transthyretin amyloidosis

Review

Author: Dasgupta, Noel ; Khatri, Wasi ; Sama, Jacob ; Markus, Nathan

Hereditary transthyretin amyloidosis is a progressive life-threatening disease characterized by deposition of abnormally folded amyloid fibrils into tissues leading to polyneuropathy and cardiomyopathy. Eplontersen, an antisense oligonucleotide has been FDA approved for the treatment of hereditary transthyretin amyloidosis with polyneuropathy in the United States. Eplontersen inhibits the translation of both variant and wildtype transthyretin in the liver, thereby preventing deposition in tissues. In the pivotal Phase III NEURO-TTRansform trial, Eplontersen significantly lowered serum transthyretin concentrations, improving neuropathic impairment and quality of life. Eplontersen was generally well tolerated in the treatment group, with the primary safety effects not significantly different from the control group. Eplontersen is suitable for long term use in patients with disease related polyneuropathy and is currently being studied for use in patients with cardiomyopathy. In this review, we discuss the clinical efficacy, mechanism of action, pharmacology, tolerability, and social determinants of health affecting the use of Eplontersen.

158

News (Medical) associated with Eplontersen

10 Jul 2026

·www.biospace.com

AstraZeneca, Ionis’ Wainua woes send waves across ATTR-CM space

iStock, Matthew Malczewski The failure of AstraZeneca and Ionis’ Wainua in a late-stage study of ATTR-CM casts doubt on Alnylam’s next-generation candidate but is good news for others in the space, including BridgeBio and Intellia Therapeutics. The surprising late-stage failure of AstraZeneca and Ionis’ antisense oligonucleotide Wainua in transthyretin amyloidosis cardiomyopathy this week has shaken the field, sowing doubt in certain therapies while building investor confidence in others. “The study here was expected to work since we know TTR [transthyretin] silencers are effective,” Stifel told investors in a Thursday note, referring to Wainua’s mechanism of suppressing the expression of the TTR protein, which is misfolded in ATTR-CM, leading to pathologic clumps in the heart. “This is absolutely the most complicated possible outcome” for Alnylam, Stifel analysts wrote, referring to the biotech’s FDA-approved Amvuttra that’s indicated for both hereditary ATTR-CM and polyneuropathy in transthyretin amyloidosis (ATTR). Alnylam is also advancing its RNAi candidate nucresiran for these conditions. Both programs work similarly to Wainua by silencing TTR. AstraZeneca and Ionis’ setback on Thursday “represents a near-term ‘win’ for ALNY by leaving Amvuttra as the only approved TTR silencer for ATTR-CM,” Truist Securities explained in a Thursday note. But the failure “raises questions about outlook for ALNY’s next-generation silencer, nucresiran, and its ability to demonstrate incremental clinical benefit in a treatment landscape increasingly dominated by background stabilizer therapy.” Earnings ‘Very Impressive’ Amvuttra ATTR-CM Sales Send Alnylam Soaring In its first commercial quarter for ATTR-cardiomyopathy, Alnylam’s Amvuttra reached roughly 1,400 patients and made more than $490 million. August 1, 2025 · 2 min read · Tristan Manalac Read more Alnylam is studying nucresiran in the Phase 3 TRITON-CM study , which is currently recruiting patients and expected to readout in 2030. The biotech “remains very confident” in nucresiran and TRITON, Oppenheimer wrote Thursday after a Q&A session with the company. In particular, the firm pointed to three key advantages emphasized by Alnylam: nucresiran is a better molecule than Wainua in potency, durability and onset; TRITON-CM is a larger trial than AstraZeneca and Ionis’ study; and Alnylam has a leadership team with proven experience. “We remain positive on ALNY ahead of TRITON,” Oppenheimer said. Alnylam ended Thursday’s trading session down 3.3%, while BridgeBio, on the other hand, swelled 15%. Tailwind for some AstraZeneca and Ionis’ failure “simplifies the ATTR-CM landscape,” Mizuho Securities wrote in a Thursday note focused on BridgeBio. The biotech owns the TTR stabilizer Attruby, approved in November 2024 for ATTR-CM. Unlike Wainua and Amvuttra, which reduce the expression of TTR, Attruby instead binds to the protein and prevents a crucial step in the formation of the disease-causing clumps. Earlier this month, BridgeBio presented a post-hoc analysis of Phase 2 and Phase 3 data for Attruby, pointing to the drug’s potential to preserve kidney function in ATTR-CM—a key renal benefit that could set it apart from other therapies in this space. Another drug that works similarly to Attruby is Pfizer’s Vyndaqel/Vyndamax, which was approved in 2019 and made $1.7 billion worldwide last year. But Phase 3 data in May suggest that Attruby has a survival edge in ATTR-CM. Cardiovascular disease BridgeBio stands up to Pfizer in ATTR-CM as late-stage data hint at better survival Indirect comparisons between BridgeBio’s Attruby and Pfizer’s tafamidis products showed a numerical survival benefit with the biotech’s drug. May 12, 2026 · 2 min read · Tristan Manalac Read more There has been no direct head-to-head comparison between the two medicines, but Mizuho nevertheless noted that Attruby is a better option in the hospital. “Because ATTR-CM is still a fatal disease, physicians should opt for the more potent stabilizer, BBIO’s Attruby.” “Peak sales estimates for Attruby may edge higher” with Wainua out of the picture, the group added. The drug brought in $362.4 million in 2025. Also in the ATTR-CM arena is Intellia Therapeutics, a biotech advancing the CRISPR-based gene therapy nexiguran ziclumeran (nex-z). Two Phase 3 studies of nex-z were subject to an FDA hold last October after a patient in one of the trials developed life-threatening liver enzyme elevations. The agency has since fully lifted the pause. Nex-z works by deactivating the TTR gene and reducing the overall expression of the protein—much like Wainua and other silencer therapies. What sets Intellia’s candidate apart, however, is that it’s designed to be a one-time therapy. The biotech is advancing nex-z in collaboration with Regeneron. The Wainua fail delivers an incremental positive to nex-z, Jefferies wrote in a Thursday note, reinforcing the analysts’ view “that achieving deep+consistent TTR knockdown is needed to drive benefit on outcomes.” “Beyond stabilizer progression, we still expect ATTR [patients] to look for the next best option,” the analysts said.

Phase 3Drug ApprovalClinical ResultGene Therapy

09 Jul 2026

·www.pharmaindustrial-india.com

AstraZeneca, Ionis' Wainua Misses Phase 3 Primary Endpoint in ATTR-CM Trial

The CARDIO-TTRansform phase 3 trial for AstraZeneca and Ionis’ Wainua (eplontersen) in patients with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) did not meet the primary efficacy endpoint of the composite outcome of cardiovascular (CV) mortality and recurrent CV clinical events up to 140 weeks compared with placebo. Wainua was generally well tolerated, with a safety profile consistent with previous results. In this contemporary patient population treated with Standard of Care (SoC), including a majority on a stabiliser, adding Wainua did not provide a statistically significant benefit on the composite outcome of CV mortality and recurrent CV events. In a prespecified subgroup analysis of patients treated with Wainua monotherapy as compared to placebo, fewer primary composite events (CV mortality and recurrent CV events) were observed and this result was nominally significant. In patients who were on stabiliser therapy at baseline, no treatment effect was observed. Sharon Barr, Executive Vice President (EVP), BioPharmaceuticals R&D, said, “The CARDIO-TTRansform trial was designed to examine the role of Wainua, a gene silencer treatment, on top of today’s standard of care in reducing recurring cardiovascular events and mortality. Although the trial did not meet its primary objective, we believe the results support greater scientific understanding of treatment approaches for the hundreds of thousands of patients worldwide suffering from this progressive and often fatal condition.” CARDIO-TTRansform is a phase 3, multicentre, randomised, double-blinded, placebo-controlled trial to evaluate the safety and efficacy of Wainua compared to placebo in participants with ATTR-CM receiving available standard of care: 57 percent of patients in each arm received a stabiliser treatment at baseline, and a further 24 percent in each arm initiated a stabiliser during the trial. AstraZeneca and Ionis will analyse the full data set to further understand the results, which will be shared with the scientific community at the European Society of Cardiology (ESC) Congress in August 2026.

Phase 3AHAClinical Result

09 Jul 2026

·www.fiercepharma.com

AZ, Ionis shares tumble on ATTR-CM trial flop, but analyst flags over-reaction

The surprising failure of AstraZeneca and Ionis in a key phase 3 trial of Wainua in patients with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) has sent the companies' shares tumbling, while those of their competitors are soaring. Shortly after the market opened on Thursday—and several hours after the companies reported the stumble—the share price of AZ was down 7%, while its Wainua partner Ionis took a 20% hit. Meanwhile, shares for indication rivals Alnylam and BridgeBio were up 10% and 15%, respectively. The U.S. biotechs were already on an upswing with the promising launches of their soon-to-be-blockbuster ATTR-CM drugs—Amvuttra in Alnylam's case and Attruby from BridgeBio. Now, AZ and Ionis' prospective challenger may be knocked out of the competition, although the partners did not address their Wainua plans in ATTR-CM directly moving forward. While there was a strong investor response, analysts from Jefferies characterized the movement as an “over-reaction,” given that 2030 sales estimates are “only mildly impacted" by the trial miss, referencing AZ’s goal to generate $80 billion in annual sales by 2030. “This was meant to be a slam dunk, making the outright failure surprising,” the Jefferies team wrote. “Pulling Wainua in ATTR-CM from our model though has limited impacts, a reflection of the breadth of AZ’s therapeutic positioning and the robustness of the growth trajectory. AZ remains a premium growth company.” The CARDIO-TTRansform study included 1,432 patients from 20 countries who received a 45-mg subcutaneous injection of Wainua or placebo every four weeks. The study did not meet its primary endpoint, which centered on reducing cardiovascular deaths or recurrent cardiovascular events through 140 weeks. Patients in the study also received standard of care, in most cases in the form of a stabilizer drug . There was a positive footnote, however, as a prespecified subgroup of patients who were treated with Wainua as a monotherapy showed a “nominally significant” improvement over placebo on the composite endpoint. But AZ’s hope of demonstrating Wainua’s benefit as an add-on therapy did not materialize. At baseline, 57% of patients in each arm were receiving stabilizers and 24% added them during the trial. “We believe these findings reflect the rapidly evolving treatment landscape, in which contemporary ATTR-CM patients are widely treated with stabilizers,” Ionis CEO Brett Monia, Ph.D., said in a release. “Although we are disappointed that the study did not meet the primary endpoint, these results have the potential to guide the treatment landscape for ATTR-CM and contribute to advancing future care for patients.” The trial miss was a surprise to William Blair analyst Myles Minter, Ph.D., given the “well-documented combination use benefit of stabilizers and silencers” in Alnylam’s HELIOS-B trial of Amvuttra, a silencer which has the same mechanism of action as Wainua. “Clearly, the data continue to support effectiveness of silencers in preventing cardiovascular events in a monotherapy setting,” Minter added. Meanwhile, Jefferies suggested that the failure could impact investors’ long-held confidence in AZ’s management. The company is known for its “exceptionally good trial design ability," with the Wainua flop potentially causing a “credibility loss,” the analysts wrote. Wainua was approved by the FDA in December of 2023 to treat polyneuropathy in adults with hereditary transthyretin-mediated amyloidosis (ATTR-PN), which affects approximately 40,000 people globally, compared to between 300,000 and 500,000 people who are living with ATTR-CM worldwide. Sales of Wainua reached $212 million last year, with Ionis collecting $49 million in royalties.

Drug ApprovalPhase 3Clinical Result

100 Deals associated with Eplontersen

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16199

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Amyloidosis, Hereditary, Transthyretin-Related	European Union	AstraZeneca AB	10 Mar 2025
Amyloidosis, Hereditary, Transthyretin-Related	Iceland	AstraZeneca AB	10 Mar 2025
Amyloidosis, Hereditary, Transthyretin-Related	Liechtenstein	AstraZeneca AB	10 Mar 2025
Amyloidosis, Hereditary, Transthyretin-Related	Norway	AstraZeneca AB	10 Mar 2025
Transthyretin-related (ATTR) familial amyloid polyneuropathy	United States	AstraZeneca AB	21 Dec 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Transthyretin Amyloid Cardiomyopathy	Phase 3	United States	Ionis Pharmaceuticals, Inc.	13 Mar 2020
Transthyretin Amyloid Cardiomyopathy	Phase 3	Japan	Ionis Pharmaceuticals, Inc.	13 Mar 2020
Transthyretin Amyloid Cardiomyopathy	Phase 3	Argentina	Ionis Pharmaceuticals, Inc.	13 Mar 2020
Transthyretin Amyloid Cardiomyopathy	Phase 3	Australia	Ionis Pharmaceuticals, Inc.	13 Mar 2020
Transthyretin Amyloid Cardiomyopathy	Phase 3	Austria	Ionis Pharmaceuticals, Inc.	13 Mar 2020
Transthyretin Amyloid Cardiomyopathy	Phase 3	Belgium	Ionis Pharmaceuticals, Inc.	13 Mar 2020
Transthyretin Amyloid Cardiomyopathy	Phase 3	Brazil	Ionis Pharmaceuticals, Inc.	13 Mar 2020
Transthyretin Amyloid Cardiomyopathy	Phase 3	Canada	Ionis Pharmaceuticals, Inc.	13 Mar 2020
Transthyretin Amyloid Cardiomyopathy	Phase 3	Czechia	Ionis Pharmaceuticals, Inc.	13 Mar 2020
Transthyretin Amyloid Cardiomyopathy	Phase 3	Denmark	Ionis Pharmaceuticals, Inc.	13 Mar 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04136184 (NEURO-TTRansform, CTgov)	Phase 3	Transthyretin-related (ATTR) familial amyloid polyneuropathy	168	Eplontersen	yuhwhxmhkq(rgplbcasvu) = kqcewlzlnd jwigwquyas (pcgzzfxsxb, 2.4123) View more	-	10 Dec 2024
NCT04136184 \| NCT01737398 (NEURO-TTRansform, FDA) Manual	Phase 2/3	Transthyretin-related (ATTR) familial amyloid polyneuropathy	204	WAINUA	hrbjeeqags(uzyzadinpu) = rnbvzcefxw uqexujbuui (wwxlzjyrdr, 1.9) View more	Positive	21 Dec 2023
				placebo	hrbjeeqags(uzyzadinpu) = oiedatkofj uqexujbuui (wwxlzjyrdr, 1.9) View more
NCT04136184 (Pubmed \| JAMA)	Phase 3	Transthyretin-mediated amyloidosis	-	Eplontersen 45 mg	yzdwbwsqeu(meuhsuslar) = Adverse events by week 66 that led to study drug discontinuation occurred in 6 patients (4%) in the eplontersen group vs 2 (3%) in the placebo group. Through week 66, there were 2 deaths in the eplontersen group consistent with known disease-related sequelae (cardiac arrhythmia; intracerebral hemorrhage); there were no deaths in the placebo group. rcecjcgzcn (jzkdlnyxox ) View more	-	17 Oct 2023
				Placebo
NCT03728634 (CTgov)	Phase 1/2	Amyloidosis, Hereditary, Transthyretin-Related	47	Placebo+Vitamin A (Multiple Dose Cohort: Placebo)	yfhkpxzeck = twcupvywmf agomcleygs (izbjecpdxl, uxwusqvqen - anbdvfjshn) View more	-	19 Dec 2022
				Vitamin A+ION-682884 (Multiple Dose Cohort A: ION-682884 45 mg)	yfhkpxzeck = merqlqdydk agomcleygs (izbjecpdxl, shvkjtrfpf - gylkvnedbs) View more
NCT04136184 (NEURO-TTRansform, Corporate Publications) Manual	Phase 3	Amyloidosis	168	Eplontersen	jzahhnfqki(wkbtiqmzrp): P-Value = <0.0001 View more	Positive	07 Sep 2022
				Placebo
NCT04302064 \| NCT03728634 (Pubmed \| Br J Clin Pharmacol)	Phase 1	Amyloidosis, Hereditary, Transthyretin-Related	-	Eplontersen	qtwclbcgqy(udqeqdicda) = omwzsfhlvx dbpnoeyony (wsahtnxbxd, 13.3) View more	-	22 Jul 2022

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