Capivasertib Drug Asset Due Diligence Report 2026

This Capivasertib 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

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 Capivasertib can convert its Small molecule drug profile and Akt biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Capivasertib (query alias: Capivasertib)
Modality / target	Small molecule drug; Akt; Akt inhibitors
Highest global status	Approved
Originator	AstraZeneca PLC
Active developers	AstraZeneca PLC, AstraZeneca AB, AstraZeneca KK

The MCP disease footprint includes Hormone-dependent prostate cancer, ER-positive/HER2-negative Breast Cancer, Breast Cancer. 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
JPRN-jRCTs031260249	Phase 2	募集前	132	無増悪生存期間（PFS）：主たる解析対象集団を対象とし、無作為化日からPD又は理由を問わない死亡日のうち早い方までの期間とする。効果判定は、Response Evaluation Criteria in Solid Tumors （RECIST） Ver.1.1に準じて評価する。
NCT07426822	Phase 2	Not yet recruiting	108	Number of patients who experience grade 2 or greater diarrhea as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
NCT07486648	Phase 1/2	Not yet recruiting	53	Part A Number of Dose-limiting toxicities (DLTs)

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

Comparative efficacy and safety of novel agents versus standard chemotherapy in first-line (1L) locally advanced or metastatic triple-negative breast cancer (TNBC): A systematic review and network meta-analyses.

Phase 2/3; n=2409; evaluation: Positive. Reported fields: -; -; -

Capivasertib plus fulvestrant in Chinese patients with HR+/HER2− advanced breast cancer: Interim analysis of CAPItrue.

Phase 3; n=195; evaluation: Positive. Reported fields: AE(possibly related to CAPI) = 88.7 % ; AE(possibly related to CAPI) = 88.7 %

Elacestrant in combination with capivasertib in patients with ER+/HER2− advanced breast cancer: Update from ELEVATE, a phase 1b/2, open-label, umbrella study.

Phase 1/2; n=31; evaluation: Positive. Reported fields: CBR(24 week) = 67.0 %

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

Capivasertib addresses Hormone-dependent prostate cancer, ER-positive/HER2-negative Breast Cancer, Breast Cancer. 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: 1 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
2005-07-27	AstraZeneca and Astex Announce New Anti-Cancer Drug Discovery Alliance	Preclinical	US$5.0M upfront; US$270.0M 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 “一种PI3K/AKT信号通路抑制剂的新晶型及其制备方法”. The milestone feed surfaced a patent-application signal described as “Tumor-preventing and tumor-treating cell-penetrating peptide targeting UFL1-AKT signal axis as well as application and pharmaceutical composition of tumor-preventing and tumor-treating cell-penetrating peptide”. The milestone feed surfaced a patent-application signal described as “Therapeutic combination of an AKT inhibitor, a BCL-2 inhibitor, and an Anti-CD20 antibody”.

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