Omecamtiv Mecarbil Drug Asset Due Diligence Report 2026

This Omecamtiv Mecarbil Drug Asset Due Diligence Report was built with PatSnap Life Sciences MCP workflows. Drug & Asset MCP establishes identity, ownership and stage; Clinical Trials MCP checks design, endpoints and readouts; Company & Deal Intelligence MCP reconstructs transaction precedent. Explore the MCP servers used in this report.

Decision date: 15 July 2026. Currency fields are presented in US$ millions as returned by the deal dataset. This is a screening memorandum, not legal, medical, patent or investment advice.

NDA/BLA

Highest phase

Registered trials

Result records

Matched deals

Executive recommendation: GO

Decision memo

Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.

The central underwriting question is whether Omecamtiv Mecarbil can convert its Small molecule drug profile and Cardiac myosin biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Omecamtiv Mecarbil (query alias: omecamtiv)
Modality / target	Small molecule drug; Cardiac myosin; Cardiac myosin stimulants
Highest global status	NDA/BLA
Originator	Amgen, Inc.
Active developers	Cytokinetics, Inc.

The MCP disease footprint includes Heart Failure, Heart failure with reduced ejection fraction, Chronic heart failure. The highest-phase flag is a useful orientation point, but the licensing case depends on indication-level evidence and rights, not the global label alone.

2. Clinical program: design and endpoint audit

Registry	Phase	Status	Enrollment	Lead primary endpoint
NCT06736574	Phase 3	Recruiting	1800	Time to the first of event of CV death, HF event, LVAD implantation/cardiac transplantation, or stroke
NCT04464525	Phase 3	Withdrawn	Not disclosed	Not disclosed
NCT04175808	Phase 1	Completed	70	Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Based on the Fridericia Method (QTcF) After Omecamtiv Mecarbil Dosing in Part B

The trial set should be diligenced for randomization, comparator relevance, endpoint hierarchy, analysis population, multiplicity, geographic mix and readout timing. For early-stage studies, safety and dose selection can be as decision-critical as response rate.

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3. Clinical readouts: what is known

Dipstick proteinuria and outcomes in patients with heart failure and reduced ejection fraction: insights from GALACTIC-HF

Phase 3; n=7790; evaluation: Positive. Reported fields: Composite endpoint(first HF event (hospitalization or urgent visit for HF) or cardiovascular death) = 34.8 per 100 person-years ( 31.8 - 38.0); Composite endpoint(first HF event (hospitalization or urgent visit for HF) or cardiovascular death) = 21.8 per 100 person-years ( 20.8 - 22.7)

Sex Differences in Heart Failure With Reduced Ejection Fraction in the GALACTIC-HF Trial

Phase 3; n=not disclosed; evaluation: Positive. Reported fields: Primary endpoint: adjusted HR = 0.8(95% CI, 0.73 - 0.88); Primary endpoint: adjusted HR = 0.8(95% CI, 0.73 - 0.88)

A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Effect of Omecamtiv Mecarbil on Exercise Capacity in Subjects With Heart Failure With Reduced Ejection Fraction and Decreased Exercise Tolerance

Phase 3; n=276; evaluation: not stated. Reported fields: Change in Peak Oxygen Uptake on Cardiopulmonary Exercise Testing From Baseline to Week 20(Least Squares Mean) = 0.207 mL/min/kg (Standard Error, 0.2412); Change in Peak Oxygen Uptake on Cardiopulmonary Exercise Testing From Baseline to Week 20(Least Squares Mean): Least squares mean difference = -0.447(95% CI, -1.024 to 0.131), P-Value = 0.13; Change in Peak Oxygen Uptake on Cardiopulmonary Exercise Testing From Baseline to Week 20(Least Squares Mean) = -0.239 mL/min/kg (Standard Error, 0.1718)

These fields are structured evidence signals, not a substitute for statistical review. The next diligence pass should reconcile denominators, confidence intervals, follow-up, censoring, dose cohorts and treatment-emergent toxicity against the original abstract, registry and protocol.

4. Market and competitive position

Omecamtiv Mecarbil addresses Heart Failure, Heart failure with reduced ejection fraction, Chronic heart failure. Commercial attractiveness rests on addressable biomarker-positive patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Small molecule drug—must demonstrate a benefit large enough to offset class-specific safety and operational costs.

The strongest market-validation signal in this screen is partner behavior: 4 matched transaction record(s) indicate that sophisticated counterparties have assigned strategic value to the asset or its rights. That does not establish net present value; probability of success, remaining R&D spend, royalties, cost sharing and territorial scope still need modeling.

5. Transaction precedent and economics

Date	Transaction	Phase at deal	Disclosed economics
2022-01-07	Cytokinetics and Royalty Pharma Announce Expanded Strategic Funding Collaboration Totaling Up to $575 Million to Support Commercial Launch of Aficamten and to Advance R&D Pipeline	Phase 2	US$50.0M upfront; US$1,025.0M stated total
2020-12-23	Servier elected to terminate the sublicense agreement between Amgen and Servier for the development and commercialization of omecamtiv mecarbil in Europe and the Commonwealth of Independent States	Not disclosed	Financial terms not disclosed
2020-11-23	Cytokinetics Regains Rights to Develop and Commercialize Omecamtiv Mecarbil and AMG 594 From Amgen	Phase 3	US$50.0M upfront; US$600.0M milestones

Headline values are not directly comparable. Diligence should normalize upfront cash, equity, development and sales milestones, tiered royalties, opt-in mechanics, cost sharing, change-of-control clauses and geography.

6. IP and freedom-to-operate screen

The milestone feed surfaced a patent-application signal described as “Omecamtiv mecarbil for use in treating heart failure by activating cardiac sarcomere”. The milestone feed surfaced a patent-application signal described as “Synthesis of omecamtiv mecarbil”. The milestone feed surfaced a patent-application signal described as “Methods of treating heart failure by administering omecamtiv mecarbil”.

The claim chart should separately test composition or sequence coverage, formulation and dosing, indication and biomarker claims, combinations, manufacturing know-how, prosecution history, term extensions and third-party blocking rights. Confirm that licensed patents, data and know-how track every granted territory and field.

7. Principal risks and diligence gates

Therapeutic index across KRAS/BRAF mutation subgroups
On-target toxicity and adaptive MAPK resistance
Lack of matched efficacy results in the current MCP result set

Cross-functional diligence should also test CMC comparability, supply chain, pharmacovigilance, regulatory correspondence, data integrity, investigator concentration, partner obligations and change-of-control restrictions.

8. Final go/no-go memorandum

GO