Dashatinib Drug Asset Due Diligence Report 2026: Clinical, IP, Market, Deals, and Go/No-Go
This Dashatinib 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
441
Registered trials
417
Result records
6
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 Dashatinib can convert its Small molecule drug profile and EphA2 x FYN x LCK x PDGFRβ x SRC x YES1 x c-Kit biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.
1. Asset identity and development status
| Asset | Dashatinib (query alias: Dashatinib) |
|---|---|
| Modality / target | Small molecule drug; EphA2 x FYN x LCK x PDGFRβ x SRC x YES1 x c-Kit; EphA2 antagonists, FYN inhibitors, LCK inhibitors |
| Highest global status | Approved |
| Originator | Bristol Myers Squibb Co. |
| Active developers | Bristol Myers Squibb Co., Bristol-Myers Squibb Pharma EEIG, Accord Healthcare SL |
The MCP disease footprint includes Aggressive-Phase Chronic Myelocytic Leukemia, Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, Philadelphia chromosome positive chronic myelogenous leukemia. 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 |
|---|---|---|---|---|
| ChiCTR2600126815 | Phase 4 | Recruiting | 79 | Progression-Free Survival (PFS) |
| NCT07493408 | Phase 2 | Not yet recruiting | 45 | Morphological relapse-free survival (M-RFS) |
| NCT07269470 | Phase 2 | Not yet recruiting | 40 | Safety and Adverse Events (AEs) |
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
REAL-WORLD ANALYSIS OF FIRST-LINE TKI USE IN CML-CP: A 16-YEAR MULTICENTER EXPERIENCE
Not Applicable; n=3210; evaluation: Positive. Reported fields: BCR-ABL ≤0.1%(12 months) = 67.4 % ; BCR-ABL ≤0.1%(12 months) = 66.7 % ; BCR-ABL ≤0.1%(12 months) = 66.2 %
FRONTLINE TREATMENT APPROACHES AND THEIR IMPACT ON THE OUTCOMES OF PATIENTS WITH CHRONIC PHASE CHRONIC MYELOID LEUKAEMIA WITH HYPERLEUKOCYTOSIS: A SINGLE CENTRE CHART REVIEW IN THE UNITED KINGDOM
Not Applicable; n=57; evaluation: Positive. Reported fields: MMR = 65.2 % ; MMR = 31.8 % ; MMR = 54.5 %
LONG-TERM OUTCOMES OF VERY LOW-DOSE DASATINIB IN OLDER PATIENTS WITH NEWLY DIAGNOSED CHRONIC-PHASE CHRONIC MYELOID LEUKEMIA: EXTENDED FOLLOW-UP OF THE DAVLEC PHASE 2 TRIAL
Phase 2; n=48; evaluation: Positive. Reported fields: AE(Grade ≥ 3) = 25.0 %
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
Dashatinib addresses Aggressive-Phase Chronic Myelocytic Leukemia, Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, Philadelphia chromosome positive chronic myelogenous leukemia. 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: 6 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 |
|---|---|---|---|
| 2025-10-16 | Onco360 to distribute Cycle Pharmaceuticals' PHYRAGO against acute lymphoblastic leukemia and chronic myeloid leukemia in the US | Approved | Financial terms not disclosed |
| 2025-08-12 | Xspray Pharma Signs License Agreement with Handa Therapeutics – to Receive up to Double-Digit Royalty on Handa’s Net Proceeds | Approved | Financial terms not disclosed |
| 2025-07-21 | Cycle Pharmaceuticals Signs Exclusive U.S. Sales License for PHYRAGO™ (dasatinib) Tablets | Approved | 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
No asset-specific patent-application milestone appeared in the returned milestone slice. That absence is not a freedom-to-operate conclusion; a dedicated family, claim, ownership, expiry, and legal-status search remains mandatory before signing.
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.
