Etravirine Drug Asset Due Diligence Report 2026

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

1. Asset identity and development status

Asset	Etravirine (query alias: etravirine)
Modality / target	Small molecule drug; RT; RT inhibitors
Highest global status	Approved
Originator	Janssen R&D Ireland Share Participation Scheme
Active developers	Janssen-Cilag GmbH, Janssen-Cilag International NV, Janssen Research & Development LLC

The MCP disease footprint includes HIV Infections. 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
NCT04273165	Phase 2	Completed	30	Adverse event number and severity
NCT04630002	Phase 1	Completed	54	Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval at Steady State (AUC[0-tau]) of GSK3640254
NCT04208373	Phase 1	Completed	32	Maximum Observed Plasma Analyte concentration (Cmax) of JNJ 64417184

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

Open-Label, Single-Sequence Study to Evaluate the Effects of Darunavir/Ritonavir and/or Etravirine on the Pharmacokinetics of GSK3640254 and the Effects of GSK3640254 on the Pharmacokinetics of Darunavir/Ritonavir and/or Etravirine in Heathy Adults

Phase 1; n=54; evaluation: not stated. Reported fields: Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval at Steady State (AUC[0-tau]) of GSK3640254(Geometric Mean) = 27.03 Hours*micrograms per milliliter (Geometric Coefficient of Variation, 33.7); Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval at Steady State (AUC[0-tau]) of GSK3640254(Geometric Mean): Ratio of geometric least square means = 1.137(90% CI, 0.9990 - 1.293); Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval at Steady State (AUC[0-tau]) of GSK3640254(Geometric Mean): Ratio of geometric least square means = 1.137(90% CI, 0.9990 - 1.293)

Third-line antiretroviral therapy, including raltegravir (RAL), darunavir (DRV/r) and/or etravirine (ETR), is well tolerated and achieves durable virologic suppression over 144 weeks in resource-limited settings: ACTG A5288 strategy trial.

Phase 4; n=257; evaluation: not stated. Reported fields: -; CD4 Count = 265 cells/mm^3 ; -

Continued Access to Etravirine (ETR) in Treatment Experienced HIV-1 Infected Subjects

Phase 3; n=180; evaluation: not stated. Reported fields: Number of Participants With At-least One Adverse Event as a Measure of Safety Until Etravirine (ETR)-Based Treatment Regimen is Commercially Available = 42 Participants ; -; -

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

Etravirine addresses HIV Infections. 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: 36 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: RT records as comparable precedents only.

Date	Transaction	Phase at deal	Disclosed economics
2022-12-20	FDA will conduct an iPSP study on Abivax's obefazimod for the treatment of IBD.	Phase 3	Financial terms not disclosed
2022-07-27	复星医药与国药控股签署战略协议加速推进阿兹夫定片全国渠道网络覆盖	Approved	Financial terms not disclosed
2022-07-25	复星医药与真实生物达成战略合作联合开发及独家商业化阿兹夫定	Approved	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 “Antibody-drug conjugates for treating infections of human immunodeficiency virus (HIV)”. The milestone feed surfaced a patent-application signal described as “Products of manufacture and therapeutic compositions for treating, ameliorating or preventing viral infections and methods for making and using them”. The milestone feed surfaced a patent-application signal described as “Methods and compositions for the treatment of viral diseases”.

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