Elacestrant hydrochloride Drug Asset Due Diligence Report 2026: Clinical, IP, Market, Deals, and Go/No-Go
This Elacestrant 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
46
Registered trials
37
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 Elacestrant hydrochloride can convert its Small molecule drug profile and ERα biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.
1. Asset identity and development status
| Asset | Elacestrant hydrochloride (query alias: elacestrant) |
|---|---|
| Modality / target | Small molecule drug; ERα; ERα antagonists |
| Highest global status | Approved |
| Originator | Eisai Co., Ltd. |
| Active developers | Berlin-Chemie/Menarini Pharma GmbH, Stemline Therapeutics, Inc., A.Menarini Industrie Farmaceutiche Riunite Srl |
The MCP disease footprint includes Locally advanced breast cancer, Advanced breast cancer, Metastatic breast 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 |
|---|---|---|---|---|
| JPRN-jRCT2071260044 | Phase 2 | 募集中 | 70 | IRC-assessed PFS |
| NCT07634601 | Phase 2 | Not yet recruiting | 50 | Proportion of patients progression-free |
| NCT07612215 | Phase 1/2 | Recruiting | 50 | Median progression-free survival |
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.
Reproduce the asset-to-trial workflow with PatSnap MCP
3. Clinical readouts: what is known
ELEGANT: Elacestrant versus standard endocrine therapy (ET) in women and men with node-positive, estrogen receptor–positive (ER+), HER2-negative (HER2−), early breast cancer (eBC) with high risk of recurrence in a global, multicenter, randomized, open-label phase 3 study.
Phase 3; n=4220; evaluation: Positive. Reported fields: AE(discontinuation) = 12.0 %
ADELA: A double-blind, placebo-controlled, randomized phase 3 trial of elacestrant (Ela) + everolimus (EVE) versus elacestrant + placebo in ER+/HER2− advanced breast cancer (aBC) patients with ESR1-mutated tumors progressing on endocrine therapy (ET) + CDK4/6i.
Phase 3; n=240; evaluation: Positive. Reported fields: AE(Grade 5) = There was one case (0.5%) of Grade 5 AEs (interruption of CDK4/6i due to increased creatine phosphokinase) with Elacestrant + Everolimus and one case (0.5%) (gastrointestinal bleeding) with Elacestrant + Placebo.
Elacestrant in combination with capivasertib in patients with ER+/HER2− advanced breast cancer: Update from ELEVATE, a phase 1b/2, open-label, umbrella study.
Phase 1/2; n=31; evaluation: Positive. Reported fields: CBR(24 week) = 67.0 %
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
Elacestrant hydrochloride addresses Locally advanced breast cancer, Advanced breast cancer, Metastatic breast 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: 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 |
|---|---|---|---|
| 2023-11-07 | Menarini Group and SciClone Pharmaceuticals Announce Exclusive Sub-Licensing Collaboration to Develop and Commercialize ORSERDU® (Elacestrant) in China to Address Advanced or Metastatic Breast Cancer | Approved | Financial terms not disclosed |
| 2023-06-30 | DRI Healthcare Trust Announces Acquisition of a Royalty Interest in the Worldwide Net Sales of Orserdu™ (elacestrant) and Reiterates Long-Term Cash Receipts Outlook | Approved | US$85.0M stated total |
| 2022-12-19 | Carrick and Menarini collaborate on phase II clinical trial for Samuraciclib combined with Elacestrant in treating metastatic breast cancer. | NDA/BLA | 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 using CDK4 inhibitors for cancer treatments”. The milestone feed surfaced a patent-application signal described as “Methods of treating estrogen receptor-positive breast cancer”. 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
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.
Build your next drug-asset diligence workflow with PatSnap Life Sciences MCP Servers
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.
