Darolutamide Drug Asset Due Diligence Report 2026: Clinical, IP, Market, Deals, and Go/No-Go
This Darolutamide 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
142
Registered trials
133
Result records
3
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 Darolutamide can convert its Small molecule drug profile and AR biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.
1. Asset identity and development status
| Asset | Darolutamide (query alias: darolutamide) |
|---|---|
| Modality / target | Small molecule drug; AR; AR antagonists |
| Highest global status | Approved |
| Originator | Orion Oyj |
| Active developers | Orion Oyj, Bayer Healthcare Co., Ltd., Bayer AG |
The MCP disease footprint includes Hormone-dependent prostate cancer, Castration-sensitive prostate cancer, Metastatic Prostate Carcinoma. 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 |
|---|---|---|---|---|
| NCT07677566 | Phase 4 | Not yet recruiting | 20 | pCR + MRD |
| NCT07649421 | Phase 2 | Not yet recruiting | 254 | 3-Year Radiographic Progression-Free Survival (rPFS) |
| ChiCTR2600126697 | Not Applicable | Not yet recruiting | 100 | 3-year biochemical progression-free survival (bPFS) |
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
Pharmacovigilance signals of androgen receptor pathway inhibitors in non-geriatric men with prostate cancer: A FAERS disproportionality analysis.
Not Applicable; n=1594913; evaluation: Positive. Reported fields: Asthenia = 4.79 ROR ; Asthenia = 1.69 ROR ; Asthenia = 2.11 ROR
Efficacy and safety of darolutamide plus androgen deprivation therapy in de novo metastatic hormone-sensitive prostate cancer: A single-center retrospective study.
Not Applicable; n=78; evaluation: Positive. Reported fields: PSA(< 0.2 ng/ml) = 83.3 %
Major adverse cardiovascular events in androgen receptor signaling inhibitor–treated patients with metastatic castration-sensitive prostate cancer.
Not Applicable; n=11588; evaluation: Positive. Reported fields: MACE(1-year cumulative incidence) = 10.7 % ( 10.0 - 11.4); MACE(1-year cumulative incidence) = 7.2 % ( 5.6 - 9.0)
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
Darolutamide addresses Hormone-dependent prostate cancer, Castration-sensitive prostate cancer, Metastatic Prostate Carcinoma. 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: 3 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 |
|---|---|---|---|
| 2022-02-18 | MGH and Orion will collaborate on a study involving the combination of darolutamide/placebo, androgen-deprivation therapy, and docetaxel for the treatment of metastatic, hormone-sensitive prostate cancer. | Approved | Financial terms not disclosed |
| 2021-04-28 | ESSA Pharma Announces Clinical Collaboration Agreement with Bayer to Evaluate the Combination of EPI-7386 and Darolutamide in Patients with Metastatic Castration-Resistant Prostate Cancer | Approved | Financial terms not disclosed |
| 2014-06-02 | Orion and Bayer enter global agreement for development and commercialization of novel prostate cancer treatment | Phase 2 | US$54.6M upfront |
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 “Synthesis method of 4-acetyl-2-chlorobenzonitrile and aryl pyrazole compound”. The milestone feed surfaced a patent-application signal described as “Inherited variants in SRD5a genes and response to hormonal therapy in prostate cancer”. The milestone feed surfaced a patent-application signal described as “Nanocrystal for the bioavailability enhancement of androgen receptor inhibitor: pharmaceutical composition and fabrication thereof”.
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.
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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.
