Ceralasertib Drug Asset Due Diligence Report 2026: Clinical, IP, Market, Deals, and Go/No-Go
This Ceralasertib 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
53
Registered trials
44
Result records
10
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 Ceralasertib can convert its Small molecule drug profile and ATR biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.
1. Asset identity and development status
| Asset | Ceralasertib (query alias: ceralasertib) |
|---|---|
| Modality / target | Small molecule drug; ATR; ATR inhibitors |
| Highest global status | Phase 3 |
| Originator | AstraZeneca Pharmaceuticals Co. Ltd. |
| Active developers | AstraZeneca Pharmaceuticals Co. Ltd., AstraZeneca PLC, AstraZeneca Global R&D (China) Co., Ltd. |
The MCP disease footprint includes Advanced Lung Non-Small Cell Carcinoma, metastatic non-small cell lung cancer, Non-Small Cell Lung 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 |
|---|---|---|---|---|
| NCT06732401 | Phase 3 | Active, not recruiting | 630 | Disease free survival (DFS) |
| NCT06769126 | Phase 2 | Recruiting | 900 | Screen success rate (Screening) |
| NCT06754761 | Phase 1 | Not yet recruiting | 8 | To evaluate absolute bioavailability Ceralasertib and PK of Ceralasertib and [14C]-Ceralasertib after administration of oral dose of Ceralasertib and IV [14C]-Ceralasertib (Part A |
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
Phase II study of olaparib plus ATR inhibitor ceralasertib in patients with metastatic breast cancer and germline BRCA1/2 pathogenic variants who progressed on prior PARP inhibitor therapy.
Phase 2; n=15; evaluation: Positive. Reported fields: ORR = 13.3 %
Phase II trial of olaparib and ceralasertib in patients with recurrent osteosarcoma: Lung-only resectable cohort efficacy and correlative biomarker results.
Phase 2; n=10; evaluation: Positive. Reported fields: EFS(12-month) = 40.0 % ( 20 - 60)
Phase II study of ceralasertib (ATR inhibitor) plus durvalumab in patients with advanced gastric cancer (AGC) who progressed on prior anti-PD-(L)1 therapy.
Phase 2; n=30; evaluation: Positive. Reported fields: ORR = 33.3 %
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
Ceralasertib addresses Advanced Lung Non-Small Cell Carcinoma, metastatic non-small cell lung cancer, Non-Small Cell Lung 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: 10 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: ATR records as comparable precedents only.
| Date | Transaction | Phase at deal | Disclosed economics |
|---|---|---|---|
| 2026-04-14 | CrossBridge Bio Enters an Agreement to be Acquired by Eli Lilly to Advance Next-Generation Dual-Payload Antibody-Drug Conjugates | Preclinical | US$300.0M stated total |
| 2025-11-17 | Repare finds fix as biotech agrees to XenoTherapeutics buyout | Phase 1 | US$94.8M stated total |
| 2025-05-30 | 爱科百发与Partex深化战略合作，共同推进新型ATR抑制剂AK0658的全球开发 | Preclinical | Financial terms not disclosed |
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 “Targeting immune suppression after ATR inhibition”. The milestone feed surfaced a patent-application signal described as “Combination of Anti-b7-h3 antibody-drug conjugate with ATR inhibitor or ATM inhibitor”. The milestone feed surfaced a patent-application signal described as “Combination of a CTPS1 inhibitor and a ATR inhibitor in cancer therapy”.
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.
