Doravirine Drug Asset Due Diligence Report 2026

This Doravirine 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 Doravirine 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	Doravirine (query alias: doravirine)
Modality / target	Small molecule drug; RT; RT inhibitors
Highest global status	Approved
Originator	Merck & Co., Inc.
Active developers	Merck Canada, Inc., Merck Sharp & Dohme Corp., MSD KK (Tokyo)

The MCP disease footprint includes HIV Infections, Acquired Immunodeficiency Syndrome, Atherosclerosis. 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
NCT06037564	Phase 4	Enrolling by invitation	210	Loss of viral suppression
NCT06602622	Phase 4	Recruiting	108	Change in body weight and BMI
NCT06719570	Phase 1	Completed	24	Area under the curve from time 0-infinity (AUC0-inf) of DOR

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

Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers

Phase 4; n=20; evaluation: not stated. Reported fields: -; -; -

Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women

Phase 1; n=7; evaluation: not stated. Reported fields: -; -; 2nd Trimester (20-26wks), Total(Median) = 1340 ng/mL (Full Range, 884 - 1420)

Doravirine for Obese Persons on Integrase Inhibitors and Tenofovir Alafenamide (The Do IT Study)

Phase 4; n=147; evaluation: not stated. Reported fields: Mean Change (Percent) in Body Weight (kg) From Entry to Week 48(Mean) = -1.84 relative change % (95% Confidence Interval, -3.37 to -0.3); Mean Change (Percent) in Body Weight (kg) From Entry to Week 48(Mean): Mean Difference (Net) = 1.36(97.5% CI, -1.20 to 3.92), P-Value = 0.23; Mean Difference (Net) = -0.89(97.5% CI, -3.34 to 1.57), P-Value = 0.41; Mean Change (Percent) in Body Weight (kg) From Entry to Week 48(Mean) = -0.47 relative change % (95% Confidence Interval, -2.09 to 1.14)

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

Doravirine addresses HIV Infections, Acquired Immunodeficiency Syndrome, Atherosclerosis. 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 “Pharmaceutical compositions containing doravirine and islatravir”. 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 “Nanoparticles and uses thereof for treatment of human immunodeficiency virus”.

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