Raltegravir Potassium Drug Asset Due Diligence Report 2026: Clinical, IP, Market, Deals, and Go/No-Go
This Raltegravir Potassium 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
248
Registered trials
188
Result records
8
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 Raltegravir Potassium can convert its Small molecule drug profile and HIV integrase biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.
1. Asset identity and development status
| Asset | Raltegravir Potassium (query alias: raltegravir) |
|---|---|
| Modality / target | Small molecule drug; HIV integrase; HIV-1 integrase inhibitors |
| Highest global status | Approved |
| Originator | Merck Sharp & Dohme Corp. |
| Active developers | Merck Sharp & Dohme BV, Merck & Co., Inc., Merck GmbH |
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 |
|---|---|---|---|---|
| NCT04258475 | Phase 4 | Unknown status | 12 | Steady-state serum pharmacokinetics analysis of raltegravir in patients undergoing ART treatment (with raltegravir) and concurrent calcium supplementation. |
| IRCT20200412047042N1 | Phase 3 | Pending | 60 | Not disclosed |
| NCT03954327 | Phase 2 | Completed | 37 | Change in alkaline phosphatase levels |
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
Phase 3b, Single Arm, Single Site Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM Clinical Trial (NCT02284035)
Phase 3; n=33; evaluation: not stated. Reported fields: -; -; -
Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Effect of Raltegravir Intensification (1.200 mg QD) on the Gut Microbiota of Chronically HIV-1 Infected Subject Over Time: THE RAGTIME
Phase 3; n=61; evaluation: not stated. Reported fields: -; Gene richness at baseline(Median) = 730732 Number of unique genes detected (Inter-Quartile Range, 552699 - 869340); -
Evaluation of the Use of Antiretroviral Regimens Containing Raltegravir for Prophylaxis of Mother-to-child-transmission of HIV Infection in Pregnant Women Presenting With Detectable Viral Load After 32 Weeks of Gestation: a Pilot Study
Phase 2/3; n=33; evaluation: not stated. Reported fields: Frequency of VL<50 at delivery = 13 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
Raltegravir Potassium 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: 8 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: HIV integrase records as comparable precedents only.
| Date | Transaction | Phase at deal | Disclosed economics |
|---|---|---|---|
| 2024-05-22 | Exavir Therapeutics Announces Entry Into a Litigation Settlement and License Agreement For Ultra-Long-Acting HIV Compounds With ViiV Healthcare | Preclinical | Financial terms not disclosed |
| 2022-07-28 | Viiv Healthcare And The Medicines Patent Pool Sign New Voluntary Licensing Agreement To Expand Access To Innovative Long-Acting Hiv Prevention Medicine | Approved | Financial terms not disclosed |
| 2022-02-01 | GSK ANNOUNCES SETTLEMENT BETWEEN ViiV HEALTHCARE AND GILEAD SCIENCES, INC. RESOLVING LITIGATION RELATING TOBIKTARVYAND ViiV’S DOLUTEGRAVIR PATENTS AND ENTRY INTO A PATENT LICENCE AGREEMENT | Not disclosed | US$1,250.0M 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 “Solid self microemulsifying drug delivery of raltegravir potassium”. The milestone feed surfaced a patent-application signal described as “Method for quantification of degradation products formed during forced degradation studies for raltegravir”. The milestone feed surfaced a patent-application signal described as “A process for the preparation of raltegravir potassium and its intermediates 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.
