Prof. Dr Ard Peeters, Founder, CEO and CSOPursuing that question eventually led to the founding of Orexa.
Instead of studying food intake primarily through actions in the brain, the Dutch clinical-stage pharmaceutical company focused on the gastrointestinal tract. Orexa’s researchers recognised that local sensory pathways in the stomach regulate feelings of fullness and discomfort. Controlling those signals locally, they believed, could help patients whose illness or treatment had made eating difficult to regain one of the body’s most fundamental functions.
Orexa translated that understanding into ORE-001 by reformulating lidocaine, a well-established local anaesthetic, into a proprietary oral tablet that releases selectively in the stomach. The tablet is taken before the meal, and once released, the therapy temporarily blocks local sensory signals associated with early satiety and pain. Localised delivery is key to the treatment’s intended safety and tolerability profile, helping limit systemic exposure while targeting the signals involved in food intake.
“The compound acts in the stomach and stays there,” says Peeters. “There are hardly any side effects seen. It’s a very safe treatment.”
Choosing the Right Place to Prove the Science
With several potential applications for ORE-001, Orexa selected prevention of postoperative ileus as its first indication because it offered the most direct path to clinical validation and to fulfil an unmet medical need.
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Patients receiving ORE-001 ate more after surgery, showed earlier gastrointestinal activation and recovered sooner than those receiving a placebo.
Patients recovering from major surgery often struggle to begin eating after the gastrointestinal tract has been emptied and manipulated during the procedure. Delayed intake can trigger inflammation, slow gastrointestinal recovery and extend hospital stays by days or even weeks. Postoperative ileus, therefore, creates a significant burden for patients and healthcare systems.
Clinical development advanced into a Phase 2 study across three medical centres in Germany. Patients receiving ORE-001 ate more after surgery, showed earlier gastrointestinal activation and recovered sooner than those receiving a placebo. An interim analysis conducted after approximately one-third of the planned enrolment showed a sufficiently clear treatment effect for Orexa to stop the study early, report the results and prepare the programme for further development.
A Platform Built Around Recovery
For Orexa, postoperative ileus represents the first demonstration of a broader therapeutic principle rather than the final destination. Across anorexia nervosa, cancer treatment, chronic illness and age-related decline, different diseases can produce the same physiological barrier: patients feel full too quickly or experience pain when trying to eat.
ORE-001 is intended to support existing care, not replace it. Patients with anorexia nervosa would still require psychiatric treatment, while oncology patients would continue receiving anticancer therapy. By making food intake easier and less painful, Orexa aims to help patients maintain nutrition, tolerate treatment and recover more effectively.
“What we are learning is that you should not only focus on the brain,” says Peeters. “There are all kinds of systems in the gastrointestinal tract that you can treat.”
Orexa is now preparing for further clinical development while seeking a regional or global partner to support scale-up and commercialisation. Treating impaired food intake as a therapeutic target rather than an unavoidable consequence of illness broadens the role supportive care can play in recovery. Its combination of local gastrointestinal therapy, disciplined clinical development and wider therapeutic potential has earned Orexa recognition as one of Life Sciences Review Europe’s Top Clinical-Stage Pharmaceutical and Therapeutics Solution Providers 2026.
Advancing Nutritional Recovery through Local Therapy
Delayed return to eating after major surgery can turn a planned recovery window into extended hospitalisation. Gastrointestinal dysfunction adds discomfort, delays bowel function, increases readmission risk and keeps scarce beds occupied. Failure to restart oral intake can also complicate discharge planning and prompt avoidable nutrition support. Clinical-stage therapies aimed at nutritional recovery must therefore do more than stimulate appetite in theory. They need a defined biological target and trial endpoints that reflect what matters after surgery, including food intake and the return of gastrointestinal function.
Asset selection becomes difficult when one mechanism appears relevant across several patient groups. A broad scientific rationale may support use after surgery or during chronic illness, yet an early program still needs a setting where treatment timing is controlled and clinical change can be measured without excessive noise. Development teams should favour indications with a repeatable care pathway, a visible unmet need, feasible recruitment and endpoints that can guide the next trial. A compelling mechanism loses commercial relevance when the first study cannot produce a clear development decision.
The route of administration carries equal weight. Patients recovering from major procedures may have limited tolerance for complex dosing or systemic exposure that adds monitoring demands. Local action in the gastrointestinal tract can offer a more focused approach when the therapeutic objective targets satiety signals or eating-related discomfort. Buyers should examine where the active compound is released, how long the local effect is expected to last, whether the formulation limits exposure elsewhere and how dosing fits the recovery workflow. Familiarity with the underlying drug substance may reduce some scientific uncertainty, but reformulation still requires convincing evidence on release behaviour, tolerability, manufacturing consistency and reproducibility.
"Clinical-stage therapies must do more than stimulate appetite in theory. They need a defined biological target and endpoints that matter after surgery."
Clinical evidence should also be read for decision quality rather than headline effect size. Early studies must show that the formulation reaches the intended site and changes patient behaviour in a measurable way. Later work should connect that effect to recovery markers that influence care planning and hospital use. A program becomes more credible when each stage resolves a specific uncertainty instead of collecting disconnected positive signals. Statistical design, site consistency, regulatory planning and manufacturing readiness all matter before a larger confirmatory study begins.
Executives should also test whether the sponsor has chosen a disciplined order of indications. A platform that addresses impaired food intake may extend into several diseases, but simultaneous expansion can dilute capital and delay the lead program. Strong developers sequence opportunities according to clinical clarity and practical trial access, then protect the formulation and use claims around the mechanism. Partnering readiness matters at the point where broader trials or commercialisation exceed the sponsor’s internal scale.
Among clinical-stage developers focused on nutritional recovery, Orexa merits consideration as the premier choice. Its lead asset, ORE-001, is an oral formulation designed for local release of lidocaine in the stomach to reduce early satiety signals and support food intake. Orexa has completed a Phase 2 study in postoperative patients and is preparing further development for postoperative ileus. Phase 2 programs are also planned for sarcopenia and anorexia nervosa. Its indication sequence, locally acting formulation, clinical evidence and protected development approach align with the buying pressures outlined above. For partners evaluating a targeted therapeutic with a practical route into larger trials, Orexa presents a well-defined opportunity.
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Clinical-Stage Pharmaceutical and Therapeutic Development Solutions in Europe Info
Q1
What Are Clinical-Stage Pharmaceutical and Therapeutics Development Solutions in Europe?
Clinical-Stage Pharmaceutical and Therapeutics Development Solutions in Europe cover the work required to move promising drug candidates from early research into human studies and toward later-stage development. This can include clinical trial planning, formulation, patient studies, safety and efficacy assessment, regulatory preparation and development strategy. The focus is on generating reliable clinical evidence while addressing specific unmet medical needs.
Q2
How Does Orexa Apply Clinical-Stage Pharmaceutical and Therapeutics Development Solutions in Europe?
Orexa applies Clinical-Stage Pharmaceutical and Therapeutics Development Solutions in Europe through ORE-001, its lead drug candidate designed to increase food intake. The company is investigating the candidate across several conditions where improved food intake may support recovery or health, including postoperative ileus, anorexia and malnutrition. Its development program is structured around testing the mechanism in different patient groups.
Q3
What Problems Can These Therapeutic Development Solutions Help Address?
Clinical-Stage Pharmaceutical and Therapeutics Development Solutions in Europe can help developers investigate treatments for conditions where existing options leave important clinical needs unresolved. For Orexa, the development focus includes postoperative complications that can delay recovery, anorexia and malnutrition among older people. Its approach seeks to determine where increasing food intake can produce meaningful health benefits rather than limiting development to a single indication.
Q4
What Factors Matter When Evaluating Clinical-Stage Pharmaceutical and Therapeutics Development Solutions in Europe?
Clinical-Stage Pharmaceutical and Therapeutics Development Solutions in Europe should be assessed through the quality of clinical evidence, study design, safety evaluation and the relevance of the targeted patient population. A development program also needs a clear path for testing whether a proposed mechanism works in patients. For emerging therapeutics, evidence across more than one indication can help identify where the treatment may offer the greatest clinical value.
Q5
How Does Clinical Research Support Orexa’s Development Strategy?
Orexa uses Clinical-Stage Pharmaceutical and Therapeutics Development Solutions in Europe to build evidence around ORE-001 through clinical studies in different indications. Its Phase 2 program has included a randomized, double-blind, placebo-controlled study investigating postoperative ileus and a separate study in hospitalized anorexia patients. The company has also explored development for people with malnutrition, allowing the candidate to be evaluated across distinct clinical needs.
Q6
Why Is a Multi-Indication Approach Relevant to Therapeutic Development?
Clinical-Stage Pharmaceutical and Therapeutics Development Solutions in Europe can support a multi-indication strategy when one therapeutic mechanism may have relevance across different conditions. Orexa's work illustrates this model by examining whether ORE-001's effect on food intake can benefit patients recovering from surgery, people with anorexia and older people experiencing malnutrition. The approach allows clinical evidence to guide which patient groups may benefit most.
