Everolimus Drug Asset Due Diligence Report 2026: Clinical, IP, Market, Deals, and Go/No-Go
This Everolimus 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
1020
Registered trials
1021
Result records
54
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 Everolimus can convert its Non-degrading molecular glue profile and mTORC1 x mTORC2 biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.
1. Asset identity and development status
| Asset | Everolimus (query alias: everolimus) |
|---|---|
| Modality / target | Non-degrading molecular glue; mTORC1 x mTORC2; mTORC1 inhibitors, mTORC2 inhibitors |
| Highest global status | Approved |
| Originator | Novartis Pharma AG |
| Active developers | Novartis Sverige AB, Sapu Nano, Novartis Pharmaceuticals Australia Pty Ltd. |
The MCP disease footprint includes Epilepsy, Epilepsies, Partial, Renal angiomyolipoma with tuberous sclerosis complex. 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-jRCTs031260249 | Phase 2 | 募集前 | 132 | 無増悪生存期間（PFS）： 主たる解析対象集団を対象とし、無作為化日からPD又は理由を問わない死亡日のうち早い方までの期間とする。効果判定は、Response Evaluation Criteria in Solid Tumors （RECIST） Ver.1.1に準じて評価する。 |
| NCT07634601 | Phase 2 | Not yet recruiting | 50 | Proportion of patients progression-free |
| NCT07658495 | Not Applicable | Active, not recruiting | 22 | Change in Balance as Measured by the Berg Balance Scale |
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
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.
Post-progression treatment (tx) analyses of evERA Breast Cancer (BC): A phase III trial of giredestrant (GIRE) + everolimus (E) in patients (pts) with estrogen receptor–positive, HER2-negative advanced BC (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i).
Phase 3; n=373; evaluation: Positive. Reported fields: CFS = 7.2 month ; CFS = 7.2 month ; CFS = 7.2 month
Everolimus and aromatase inhibitors for advanced and recurrent low-grade serous ovarian carcinoma.
Not Applicable; n=8; evaluation: Positive. Reported fields: DCR = 87.5 %
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
Everolimus addresses Epilepsy, Epilepsies, Partial, Renal angiomyolipoma with tuberous sclerosis complex. Commercial attractiveness rests on addressable biomarker-positive patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Non-degrading molecular glue—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: 54 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
Transaction-scope note: No direct asset-specific transaction was returned. The table below shows target-level comparable: mTORC1 x mTORC2 records as comparable precedents only.
| Date | Transaction | Phase at deal | Disclosed economics |
|---|---|---|---|
| Quince Announces Acquisition of Orphai and up to $187 Million Private Placement to Advance Pulmonary Pipeline | Phase 2 | US$3.8M stated total | |
| 2025-10-28 | Orchestra BioMed and Terumo Enter into New $30 Million Virtue SAB Strategic Agreements | Approved | Financial terms not disclosed |
| 2025-09-23 | Healx Partners with Vuja De Sciences to Advance AI-Driven Therapy for Metastatic Osteosarcoma Recurrence | IND Approval | 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 “Macrocyclic blockers for use in the reduction of peripheral side effects due to everolimus therapy”.
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
- Class crowding and differentiation versus other PD-(L)1/VEGF agents
- Immune and anti-angiogenic safety, including bleeding and cardiovascular risk
- Biomarker strategy, indication selection, and head-to-head endpoint execution
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.
