Pacritinib Drug Asset Due Diligence Report 2026

This Pacritinib 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 Pacritinib can convert its Small molecule drug profile and ALK2 x CSF-1R x FLT3 x IRAK1 x JAK2 biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Pacritinib (query alias: pacritinib)
Modality / target	Small molecule drug; ALK2 x CSF-1R x FLT3 x IRAK1 x JAK2; ALK2 inhibitors, CSF-1R antagonists, FLT3 inhibitors
Highest global status	Approved
Originator	CTI BioPharma Corp.
Active developers	Swedish Orphan Biovitrum AB, Sobi, Inc., Xiangyang Central Hospital

The MCP disease footprint includes Post-essential thrombocythemia myelofibrosis, Post-polycythemia vera myelofibrosis, Primary Myelofibrosis. 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
NCT07394153	Phase 2	Recruiting	30	Decrease in reticulin fibrosis in bone marrow (BM)
NCT07447817	Phase 2	Not yet recruiting	26	Change in spleen volume
NCT07387354	Phase 1/2	Not yet recruiting	25	Optimal Dose of Pacritinib in Combination with Azacitidine - Phase 1

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

Treatment patterns and outcomes in pacritinib-treated patients with MF and higher platelet count: MY-PAC study.

Not Applicable; n=169; evaluation: Positive. Reported fields: Hb(increase; <10 g/dL at index and Hb at Day 180) = 0.8 g/dL

REAL-WORLD TREATMENT PATTERNS AND OUTCOMES IN PATIENTS WITH MYELOFIBROSIS TREATED FIRST-LINE WITH PACRITINIB OR RUXOLITINIB

Not Applicable; n=207; evaluation: Positive. Reported fields: Median spleen length reduction = 41.0 % ; Median spleen length reduction = 45.0 %

Treatment patterns and outcomes in patients with myelofibrosis treated with pacritinib following a switch from ruxolitinib: The my-PAC study

Not Applicable; n=169; evaluation: Positive. Reported fields: Hb(day 180) = 0.8 g/dL ( 0.0 - 1.0)

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

Pacritinib addresses Post-essential thrombocythemia myelofibrosis, Post-polycythemia vera myelofibrosis, Primary Myelofibrosis. 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
2023-05-10	Sobi completes acquisition of CTI BioPharma Corp.	Approved	US$1,700.0M stated total
2021-08-25	CTI BioPharma and DRI Healthcare Trust Announce up to $135 Million Debt and Royalty Transaction	NDA/BLA	US$50.0M upfront; US$85.0M milestones; US$135.0M stated total
2016-10-24	CTI Regains Rights to Pacritinib from Baxalta	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 “Combination therapy comprising Anti-CD22 antibody-drug conjugate and IRAK1 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