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Carvedilol Drug Asset Due Diligence Report 2026: Clinical, IP, Market, Deals, and Go/No-Go

16 July 2026
8 min read

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This Carvedilol 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.

Approved

Highest phase

277

Registered trials

62

Result records

2

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 Carvedilol can convert its Small molecule drug profile and β1-adrenergic receptor x β2-adrenergic receptor biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

AssetCarvedilol (query alias: Carvedilol)
Modality / targetSmall molecule drug; β1-adrenergic receptor x β2-adrenergic receptor; β1-adrenergic receptor antagonists, β2-adrenergic receptor antagonists
Highest global statusApproved
OriginatorF. Hoffmann-La Roche Ltd.
Active developersDaiichi Sankyo Co., Ltd., Alvogen Korea Co., Ltd., InnoPharmax, Inc.

The MCP disease footprint includes Atrial Fibrillation, Angina, Stable, 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

RegistryPhaseStatusEnrollmentLead primary endpoint
NCT07521332Phase 4Recruiting220First Occurrence of Portal Hypertension-Related Complications
ChiCTR2600125356Phase 2Not yet recruiting54Objective Response Rate (ORR)
NCT07577518Not ApplicableNot yet recruiting2301Number of Participants with Patient-oriented composite outcome (POCO), defined as the composite of cardiovascular death, non-fatal myocardial infarction (MI), or clinically driven revascularization

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

Clinical study evaluating the gastroprotective effect of carvedilol in patients with ischemic heart disease on aspirin therapy

Not Applicable; n=66; evaluation: Positive. Reported fields: GAS-17: P-Value = 0.015; GAS-17: P-Value = 0.015

Risk-guided cardioprotection with carvedilol in patients with breast cancer (CCT guide): a phase 1 randomized clinical trial

Phase 1; n=68; evaluation: Positive. Reported fields: Adverse events of interest = 13 % ; Adverse events of interest = 9 % ; Adverse events of interest = 4 %

Combination of carvedilol with variceal band ligation in prevention of first variceal bleed in Child-Turcotte-Pugh B and C cirrhosis with high-risk oesophageal varices: the ‘CAVARLY TRIAL’

Not Applicable; n=330; evaluation: Positive. Reported fields: Overall mortality(1-year) = 14.5 % ; Overall mortality(1-year) = 20 % ; Overall mortality(1-year) = 6.3 %

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

Carvedilol addresses Atrial Fibrillation, Angina, Stable, 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: 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

DateTransactionPhase at dealDisclosed economics
2019-07-08因华C08001高血药新药授权山东新时代药业,授权金人民币4500万元PreclinicalUS$6.5M stated total
2000-08-31SKB sells Kytril to Roche; Famvir, Vectavir/Denavir to NovartisApprovedUS$400.0M stated total

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 “Application of carvedilol in preparation of medicine for treating leukemia”. The milestone feed surfaced a patent-application signal described as “Combination product using 3,4-methylenedioxymethamphetamine and carvedilol for the treatment of psychiatric disorders”. The milestone feed surfaced a patent-application signal described as “Preparation of soluble form of carvedilol”.

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

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

Required pre-signing gates: reproduce key efficacy analyses; complete an indication-specific safety review; run a full patent-family and freedom-to-operate search; model risk-adjusted economics by territory; and reconcile all rights, sublicenses and encumbrances.

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Data provenance: PatSnap Drug & Asset MCP, Clinical Trials MCP, and Company & Deal Intelligence MCP; accessed 15 July 2026. Counts and status fields may change as source records update.

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