Ipatasertib Dihydrochloride Drug Due Diligence Report 2026

This Ipatasertib Dihydrochloride 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 Ipatasertib Dihydrochloride 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	Ipatasertib Dihydrochloride (query alias: ipatasertib)
Modality / target	Small molecule drug; Akt; AKT gene inhibitors
Highest global status	Phase 3
Originator	Array BioPharma, Inc.
Active developers	Hoffmann-La Roche, Inc., Roche Pharma AG, Genentech, Inc.

The MCP disease footprint includes ER-positive/HER2-negative Breast Cancer, Ovarian mixed epithelial carcinoma, Ovarian Serous Adenocarcinoma. 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
NCT05862285	Phase 3	Recruiting	100	Number of Participants With Continued Access to Roche IMP(s)-Based Therapy and/or Comparator Agent(s)
NCT05564377	Phase 2	Recruiting	2900	Accrual of patients to ComboMATCH treatment trials
NCT06400251	Phase 2	Active, not recruiting	35	Objective Response Rate (ORR)

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: -; -; -

A phase 2 study of ipatasertib in combination with pembrolizumab for first-line treatment of recurrent or metastatic squamous cell cancer of the head and neck.

Phase 2; n=52; evaluation: Positive. Reported fields: PFS = 6.2 month ( 1.9 - 13.5); PFS = 8.1 month ( 4 - NA)

Safety and antitumour activity of ipatasertib combined with endocrine therapy and a CDK4/6 inhibitor in HR+/HER2– metastatic breast cancer (TAKTIC): a single-centre, open-label, phase 1b trial

Phase 1; n=77; evaluation: Positive. Reported fields: AE(grade 3-4) = Common grade 3-4 adverse events related to study treatment (occurring in >5% of patients) were neutropenia (30 [39%] of 77), leukopenia (15 [19%]), diarrhoea (14 [18%]), rash (seven [9%]), lymphopenia (three [4%]), and anaemia (four [5%]). ; AE(grade 3-4) = Common grade 3-4 adverse events related to study treatment (occurring in >5% of patients) were neutropenia (30 [39%] of 77), leukopenia (15 [19%]), diarrhoea (14 [18%]), rash (seven [9%]), lymphopenia (three [4%]), and anaemia (four [5%]).

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

Ipatasertib Dihydrochloride addresses ER-positive/HER2-negative Breast Cancer, Ovarian mixed epithelial carcinoma, Ovarian Serous Adenocarcinoma. 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: 24 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

Transaction-scope note: No direct asset-specific transaction was returned. The table below shows target-level comparable: Akt records as comparable precedents only.

Date	Transaction	Phase at deal	Disclosed economics
2026-04-23	HealthCare Royalty Announces Royalty Monetization Agreement for Modeyso® Commercial Royalties	Approved	Financial terms not disclosed
2025-11-12	Fangda Assisted Laekna in Entering into an Exclusive Licensing Agreement with Qilu Pharma for LAE002 (AFURESERTIB) in China	Phase 3	US$287.3M stated total
2025-03-05	Jazz Pharmaceuticals Completes Acquisition of Chimerix	NDA/BLA	US$935.0M 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 “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 “Cancer treatment using AKT inhibitors and PLK1 inhibitors”. The milestone feed surfaced a patent-application signal described as “AKT inhibitor in combination with PIM kinase inhibitor”.

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