imipenem relebactam Drug Asset Due Diligence Report 2026

This Cilastatin Sodium/Imipenem/Relebactam 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 Cilastatin Sodium/Imipenem/Relebactam can convert its Small molecule drug profile and PBPs x β-lactamase biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Cilastatin Sodium/Imipenem/Relebactam (query alias: imipenem relebactam)
Modality / target	Small molecule drug; PBPs x β-lactamase; PBPs inhibitors, β-lactamase inhibitors
Highest global status	Approved
Originator	Merck Sharp & Dohme Corp.
Active developers	Merck Sharp & Dohme Corp., Merck Sharp & Dohme BV, Merck & Co., Inc.

The MCP disease footprint includes Infectious Diseases, Hospital acquired bacterial pneumonia, Ventilator associated bacterial pneumonia. 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
NCT05561764	Phase 4	Terminated	4	Imipenem Clearance
NCT05146154	Phase 4	Withdrawn	Not disclosed	Pharmacokinetic parameters of imipenem and relebactam
NCT04785924	Phase 4	Withdrawn	Not disclosed	Clinical success

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

A Multicenter, Randomized, Double-Blind, Comparative, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Imipenem/Cilastatin/Relebactam in Adults With Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia (EudraCT no. 2022-000081-18) (EUCTR no. 2022-501952-27-00) (IND no. 146614)

Phase 3; n=450; evaluation: not stated. Reported fields: Day 14 All-cause Mortality Rate = 3.0 percentage of participants ; Day 14 All-cause Mortality Rate: Treatment difference = 0.2(95% CI, -3.5 to 4.0); Day 14 All-cause Mortality Rate = 2.7 percentage of participants

A phase III, randomized, controlled noninferiority trial to study the efficacy and safety of imipenem/cilastatin/relebactam (IMI/REL) vs piperacillin/tazobactam (PIP/TAZ) in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP)

Phase 3; n=270; evaluation: Positive. Reported fields: CR = Secondary outcomes were comparable between treatment groups, including favorable CR ; CR = Secondary outcomes were comparable between treatment groups, including favorable CR

Pharmacokinetics of Imipenem/Cilastatin/Relebactam in Critically Ill Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)

Phase 1; n=8; evaluation: not stated. Reported fields: Imipenem Clearance(Mean) = 15.21 Liters per hour (Standard Deviation, 6.52); -; -

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

Cilastatin Sodium/Imipenem/Relebactam addresses Infectious Diseases, Hospital acquired bacterial pneumonia, Ventilator associated bacterial pneumonia. 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: 0 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: PBPs x β-lactamase records as comparable precedents only.

Date	Transaction	Phase at deal	Disclosed economics
No matched asset transaction returned.

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 “Β-lactamase inhibitors”.

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