Raloxifene Hydrochloride Drug Due Diligence Report 2026

This Raloxifene Hydrochloride 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 Raloxifene Hydrochloride can convert its Small molecule drug profile and ER biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Raloxifene Hydrochloride (query alias: raloxifene)
Modality / target	Small molecule drug; ER; ERs modulators
Highest global status	Approved
Originator	Eli Lilly & Co.
Active developers	Dompe Farmaceutici SpA, Teva Pharmaceuticals Europe BV, Eli Lilly Nederland BV

The MCP disease footprint includes Breast Cancer, Osteoporosis, Postmenopausal, Hemorrhagic Fever, Ebola. 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
NCT06062810	Phase 2/3	Active, not recruiting	600	Measure and Report Raloxifene oncology drug target ER SNP Genotypes which are effectiveness associated.
NCT06944145	Phase 2	Recruiting	242	Clinical response to at 12 months after study enrollment
NCT07470606	Phase 2	Not yet recruiting	108	Hippocampal volume changes

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

Multicenter, Adaptive, Randomized, Placebo-controlled, Double Blind, Parallel-group Phase 2/3 Trial, to Study Efficacy and Safety of Two Doses of Raloxifene in Adult Paucisymptomatic COVID-19 Patients.

Phase 2/3; n=61; evaluation: not stated. Reported fields: Number of Participants With Undetectable SARS-CoV-2 at PCR at Day 7 After Randomization in the FAS = 0 Participants ; Number of Participants With Undetectable SARS-CoV-2 at PCR at Day 7 After Randomization in the FAS: Odds Ratio (OR) = 9.990(95% CI), P-Value = 0.0109; Odds Ratio (OR) = 5.414(95% CI), P-Value = 0.0673; Odds Ratio (OR) = 12.186(95% CI), P-Value = 0.0061; Odds Ratio (OR) = 5.936(95% CI), P-Value = 0.0567; Number of Participants With Undetectable SARS-CoV-2 at PCR at Day 7 After Randomization in the FAS: Odds Ratio (OR) = 9.990(95% CI), P-Value = 0.0109; Odds Ratio (OR) = 5.414(95% CI), P-Value = 0.0673; Odds Ratio (OR) = 12.186(95% CI), P-Value = 0.0061; Odds Ratio (OR) = 5.936(95% CI), P-Value = 0.0567

P0903 EFFECTS OF OSTEOPOROSIS MEDICATIONS ON BONE FRACTURE IN PATIENTS WITH CHRONIC KIDNEY DISEASE

Not Applicable; n=39128; evaluation: Negative. Reported fields: CV events = 7.5 %

Raloxifene through its Cannabinoid Type-2 Receptor Inverse Agonism Mitigates Visual Deficits and Pathology after Impact TBI

Phase 2; n=not disclosed; evaluation: Positive. Reported fields: Light aversion = reduced or eliminated ; Light aversion = reduced or eliminated

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

Raloxifene Hydrochloride addresses Breast Cancer, Osteoporosis, Postmenopausal, Hemorrhagic Fever, Ebola. 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: 2 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
2020-11-18	Gyeonggi Provincial Medical Center and Dompe farmaceutici will sign an LOI to collaborate on the development of a COVID-19 treatment utilizing raloxifene.	Preclinical	Financial terms not disclosed
2019-01-28	Lotus Pharmaceutical to purchase Takeda's Evista for osteoporosis in seven APAC countries.	Approved	US$22.0M 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 “Combination therapy using CDK4 inhibitors for cancer treatments”. The milestone feed surfaced a patent-application signal described as “Combinations comprising VAV1-targeting degraders”. The milestone feed surfaced a patent-application signal described as “Treatment of cancer with an AKT1 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