Umbralisib Tosylate Drug Asset Due Diligence Report 2026

This Umbralisib Tosylate 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 2

Highest phase

Registered trials

Result records

Matched deals

Executive recommendation: CONDITIONAL GO

Decision memo

Advance with milestone-based economics while efficacy durability, safety differentiation, patent scope, and market positioning are validated.

The central underwriting question is whether Umbralisib Tosylate can convert its Small molecule drug profile and CK1ε x PI3Kδ biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Umbralisib Tosylate (query alias: umbralisib)
Modality / target	Small molecule drug; CK1ε x PI3Kδ; CK1ε inhibitors, PI3Kδ inhibitors
Highest global status	Phase 2
Originator	TG Therapeutics, Inc.
Active developers	AstraZeneca PLC, TG Therapeutics, Inc.

The MCP disease footprint includes Chronic lymphocytic leukaemia refractory, Small Lymphocytic Lymphoma. 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
NCT04783415	Phase 2	Active, not recruiting	12	Complete Response (CR) Rate After Induction (Six Cycles)
NCT04692155	Phase 1/2	Terminated	1	Rate of Complete Remission at the End of Induction Treatment
NCT05152459	Phase 1/2	Withdrawn	Not disclosed	Dose-limiting toxicity

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

A Phase 2 Study of Umbralisib and Rituximab as Initial Therapy for Patients With Follicular Lymphoma and Marginal Zone Lymphoma

Phase 2; n=18; evaluation: not stated. Reported fields: -; -; CR = 7 Participants

A Phase 2 Study of Acalabrutinib, Umbralisib, and Ublituximab (AU2) in Relapsed and Previously Untreated CLL Patients

Phase 2; n=29; evaluation: not stated. Reported fields: Complete Remission (CR) Rate After 24 Cycles = 0.29 proportion of participants (95% Confidence Interval, 0.084 - 0.582); -; -

A Phase 2 Study to Assess the Safety and Efficacy of TGR-1202 (Umbralisib) in Patients With Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K-Delta Inhibitor Therapy

Phase 2; n=51; evaluation: not stated. Reported fields: PFS(Median) = 19.7 months (95% Confidence Interval, 12.9 - 24.8); -; -

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

Umbralisib Tosylate addresses Chronic lymphocytic leukaemia refractory, Small Lymphocytic Lymphoma. 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
2012-08-16	TG Therapeutics and Rhizen Pharmaceuticals Announce Global Agreement for Development and Commercialization of Novel PI3K Delta Selective Inhibitor, TGR-1202	Phase 3	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 “Drug combination comprising Anti-CD37 antibody maytansine conjugate and BCL2 inhibitor or PI3k inhibitor”. The milestone feed surfaced a patent-application signal described as “Methods of treating squamous cell carcinoma with a farnesyltransferase inhibitor and a PI3k inhibitor”. The milestone feed surfaced a patent-application signal described as “Methods of cancer treatment using a combination of BTK inhibitors and PI3 kinase inhibitors”.

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

CONDITIONAL GO