Olpasiran Drug Asset Due Diligence Report 2026

This Olpasiran 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.

Phase 3

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 Olpasiran can convert its siRNA profile and Lp(a) biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Olpasiran (query alias: olpasiran)
Modality / target	siRNA; Lp(a); lipoprotein(a) inhibitors, RNAi
Highest global status	Phase 3
Originator	Arrowhead Pharmaceuticals, Inc.
Active developers	Amgen, Inc., Arrowhead Pharmaceuticals, Inc.

The MCP disease footprint includes Myocardial Infarction, Lipoprotein (a) hyperlipoproteinemia, Atherosclerosis. 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
NCT07136012	Phase 3	Recruiting	11000	Time to CHD Death, Myocardial Infarction, or Urgent Coronary Revascularization, Whichever Occurs First
NCT07293260	Phase 3	Recruiting	406	Change in NCP Volume from Baseline to Week 72
NCT06411860	Phase 1	Completed	32	Placebo-corrected Change From Baseline in QT Corrected for Heart Rate (HR) Interval Based on the Fridericia Correction (QTcF) (ΔΔQTcF) After Olpasiran Dosing

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.

Reproduce the asset-to-trial workflow with PatSnap MCP

3. Clinical readouts: what is known

3个月一次，强效降脂超90%的siRNA疗法；诺和诺德减重新药新剂型在中国获批临床…… | TIDES周报

临床2期; n=272; evaluation: 积极. Reported fields: OxPL-apoB(36-week): Difference (%) = -51.6(95% CI, -64.9 ~ -38.2), P-Value = < 0.001; Difference (%) = -89.7(95% CI, -103.0 ~ -76.4), P-Value = < 0.001; Difference (%) = -92.3(95% CI, -105.6 ~ -78.9), P-Value = < 0.001; Difference (%) = -93.7(95% CI, -107.1 ~ -80.3), P-Value = < 0.001; OxPL-apoB(36-week): Difference (%) = -51.6(95% CI, -64.9 ~ -38.2), P-Value = < 0.001; Difference (%) = -89.7(95% CI, -103.0 ~ -76.4), P-Value = < 0.001; Difference (%) = -92.3(95% CI, -105.6 ~ -78.9), P-Value = < 0.001; Difference (%) = -93.7(95% CI, -107.1 ~ -80.3), P-Value = < 0.001; OxPL-apoB(36-week): Difference (%) = -51.6(95% CI, -64.9 ~ -38.2), P-Value = < 0.001; Difference (%) = -89.7(95% CI, -103.0 ~ -76.4), P-Value = < 0.001; Difference (%) = -92.3(95% CI, -105.6 ~ -78.9), P-Value = < 0.001; Difference (%) = -93.7(95% CI, -107.1 ~ -80.3), P-Value = < 0.001

An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Olpasiran in Chinese Subjects With Elevated Serum Lipoprotein(a)

Phase 1; n=24; evaluation: not stated. Reported fields: Maximum Observed Concentration (Cmax) of Olpasiran(Geometric Mean) = 144 ng/mL (Geometric Coefficient of Variation, 55.5); -; Maximum Observed Concentration (Cmax) of Olpasiran(Geometric Mean) = 549 ng/mL (Geometric Coefficient of Variation, 71.5)

Early health technology assessment of gene silencing therapies for lowering lipoprotein(a) in the secondary prevention of coronary heart disease

Phase 3; n=not disclosed; evaluation: Positive. Reported fields: -; Discounted QALYs saved = 0.87 QALYs

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

Olpasiran addresses Myocardial Infarction, Lipoprotein (a) hyperlipoproteinemia, Atherosclerosis. Commercial attractiveness rests on addressable biomarker-positive patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—siRNA—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: 2 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
2022-11-09	Royalty Pharma Agrees to Acquire Royalty Interest in Olpasiran From Arrowhead for $250 million and Future Milestones	Phase 2	US$250.0M upfront; US$160.0M milestones; US$410.0M stated total
2016-09-29	Amgen And Arrowhead Pharmaceuticals Announce Two Cardiovascular Collaborations	Preclinical	US$56.5M upfront; US$617.0M 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 “METHODS FOR TREATING ATHEROSCLEROTIC CARDIOVASCULAR DISEASE WITH LPA-TARGETED RNAi CONSTRUCTS”. The milestone feed surfaced a patent-application signal described as “RNAi constructs and methods for inhibiting LPA expression”. The milestone feed surfaced a patent-application signal described as “Compositions and methods for inhibiting gene expression of lpa”.

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

Class crowding and differentiation versus other PD-(L)1/VEGF agents
Immune and anti-angiogenic safety, including bleeding and cardiovascular risk
Biomarker strategy, indication selection, and head-to-head endpoint execution

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