For Medical Professionals

Novilora™ for Medical Professionals

A Science-Informed Nutritional Approach to Peripheral Nerve Support

Novilora™ is the U.S. registered product name for OnLife®, an orally administered nutritional supplement developed in Italy and formulated with a defined combination of specific fatty acids and palmitoylethanolamide (PEA).

OnLife® was evaluated in the prospective, multicenter, single-arm observational STEFANO study involving adults with chemotherapy-induced peripheral neuropathy (CIPN) following paclitaxel- or oxaliplatin-based treatment. This Medical Professional Center provides an overview of the formulation, its proposed nutritional and physiological rationale, the available clinical evidence, its European development, and options for making Novilora™ available directly to patients.

Review the Clinical Evidence Provide Novilora™ to Patients

Intended audience. This page is intended for physicians, advanced practice clinicians, oncology nurses, pharmacists, registered dietitians, and other qualified healthcare professionals. Novilora™ is a nutritional supplement and is not a prescription drug. It is not intended to diagnose, treat, cure, or prevent disease.

Clinical context

The Clinical Challenge of Chemotherapy-Induced Peripheral Neuropathy

Chemotherapy-induced peripheral neuropathy is a clinically significant and potentially persistent complication associated with several neurotoxic antineoplastic agents, including taxanes and platinum compounds.

CIPN most commonly manifests as a predominantly sensory, length-dependent neuropathy. Patients may report paresthesia, dysesthesia, numbness, burning discomfort, altered temperature sensitivity, impaired vibratory perception, and symptoms affecting balance, fine motor function, sleep, mobility, and activities of daily living. Motor and autonomic manifestations may also occur.

CIPN can persist after completion of chemotherapy and may materially affect function, quality of life, and survivorship. Novilora™ is intended to provide targeted nutritional support for peripheral nerve health in this clinical context.

Formulation & rationale

A Defined Fatty Acid and PEA Formulation

Novilora™ is the U.S. product name for OnLife®, which combines a defined group of specific fatty acids with palmitoylethanolamide (PEA).

The formulation includes physiologically relevant lipids selected for their roles in cellular membrane composition, myelin integrity, lipid and energy metabolism, inflammatory balance, and intercellular signaling. PEA is an endogenous fatty acid amide that has been studied for its role in neuroinflammatory signaling and tissue homeostasis.

The formulation also contains magnesium pidolate and lycopene. Together, these components are intended to address specific nutritional requirements associated with peripheral nerve health.

Structural lipids

Provides nutritional components relevant to peripheral nerve-cell membrane composition.

Myelin integrity

Supports the lipid substrates involved in myelin structure.

Cellular energy metabolism

Includes lipids studied for their role in cellular energy metabolism.

Neuroinflammatory balance

PEA has been studied for its role in neuroinflammatory signaling and tissue homeostasis.

Peripheral nerve signaling

Provides nutritional components involved in intercellular signaling in peripheral nerves.

Oxidative balance

Contains lycopene, a carotenoid studied for its role in oxidative balance.

Scientific rationale is not clinical efficacy. These pathways describe the biological rationale for the formulation. Clinical outcomes are summarized separately from the STEFANO observational study.

Defined fatty-acid profile

EPA + DHA

Alpha-Linolenic Acid

Linoleic Acid

Oleic Acid

Palmitic Acid + Stearic Acid

Supplement Facts & ingredient list. [NEEDS CONFIRMATION: COMPLETE LABEL-APPROVED SUPPLEMENT FACTS, INGREDIENT QUANTITIES, OTHER INGREDIENTS, AND ALLERGEN INFORMATION]

Clinical evidence

Published Clinical Evaluation

The OnLife® formulation was evaluated in the prospective, multicenter STEFANO observational study involving adults with persistent CIPN after completing adjuvant chemotherapy across 21 oncology centers.

The analysis included 146 patients:

75 patients with breast cancer previously treated with a paclitaxel-based regimen
71 patients with colon cancer previously treated with an oxaliplatin-based regimen

Participants received OnLife® for three months. Peripheral sensory neuropathy and peripheral motor neuropathy were assessed before and after the evaluation period. Patient-reported CIPN symptoms and quality-of-life measures were also evaluated.

Paclitaxel cohort — sensory outcome

Physician-assessed sensory benefit was 85.1%, comprising 31.1% improved and 54.1% stabilized.

Paclitaxel cohort — motor outcome

Physician-assessed motor benefit was 87.5%, comprising 37.5% improved and 50.0% stabilized.

In the paclitaxel cohort, 45.9% reported fewer sensory symptoms and functional limitations, while 37.5% reported fewer motor symptoms and functional limitations. Mean Global Health Status / Quality of Life increased 13.1 points and mean Physical Functioning increased 15.5 points during three months of OnLife® treatment.

Interpreting the Evidence

The STEFANO study was prospective, multicenter, and observational. It was not a randomized, placebo-controlled clinical trial. Therefore, the study cannot establish how much observed improvement was attributable to OnLife® versus treatment-independent recovery after chemotherapy. The authors called for prospective randomized multicenter research to further confirm benefit.

Citations

Professional materials. See the clinician resource directory below for currently available primary sources and materials awaiting confirmation.

Origin

Developed in Italy

The formulation behind Novilora™ was developed by Again Life Italia, an Italian research and development company with a focus on nutritional formulations and the physiological processes associated with inflammation and neuroinflammation.

OnLife® was developed as a targeted nutritional formulation incorporating the proprietary F.A.G.® fatty acid complex. Novilora™ now brings this established European formulation to the United States under its registered U.S. product name.

The Scientific Vision Behind the Formulation

Dr. Raffaele Migliaccio
Internist and oncologist · President of Again Life Italia

Dr. Raffaele Migliaccio is an Italian internist and oncologist whose work focuses on supportive cancer care and quality of life during treatment. He is the creator of the formulation behind OnLife®, now Novilora™ in the U.S.

He is a named inventor on the patent family covering the combination of specific fatty acids and PEA underlying OnLife®, and collaborates with researchers at the University of Milan and Stanford University.

[NEEDS CONFIRMATION: EDUCATION, MEDICAL CREDENTIALS, ADDITIONAL PATENTS, PUBLICATIONS, AND FULL APPROVED BIOGRAPHY]

Clinician resources

Evidence, formulation, use, and safety

STEFANO full publication

Available

Open resource

ClinicalTrials.gov registration

Available

Open resource

Clinician study summary

Available

Open resource

Formulation / ingredient profile

Available

Open resource

Supplement Facts

[NEEDS CONFIRMATION]

Mechanism / biological rationale

Available

Open resource

Suggested use

Available

Open resource

Safety information

[NEEDS CONFIRMATION]

Dr. Migliaccio biography

[NEEDS CONFIRMATION]

Patents

[NEEDS CONFIRMATION]

References / bibliography

In progress

Open resource

European experience

European Development and Clinical Experience

Before its introduction in the United States as Novilora™, the OnLife® formulation was made available in European markets, including Germany and Switzerland.

The STEFANO observational study was sponsored by Swiss Medical Food AG, and its results were published in the peer-reviewed journal Oncology Research and Treatment. Study findings were also presented in connection with the 2020 German Cancer Congress in Berlin.

OnLife® has subsequently been distributed through established European channels serving patients and healthcare professionals. This history provides commercial and clinical-experience context for the U.S. introduction of Novilora™.

Specific figures on years of availability, packages distributed, participating physicians or pharmacies, and post-market or pharmacovigilance data will be added once documented by Novilora.

Professional purchasing

Provide Novilora™ Directly to Your Patients

Novilora™ offers a professional purchasing program for qualified medical practices, oncology and survivorship programs, integrative medicine practices, rehabilitation programs, pharmacies, and other approved healthcare organizations.

The program allows participating practices to maintain Novilora™ inventory and make it conveniently available to appropriate patients as part of a clinician-supervised nutritional-support plan.

Convenient access for patients through a trusted clinical setting
U.S.-based product availability and fulfillment
Professional product and formulation information
Access to published clinical research
Educational resources for clinicians and patients
Volume-based professional pricing
Support from the Novilora professional-services team

Professional pricing

Loading…

Professional purchasing is available only to verified healthcare practices, licensed healthcare professionals, pharmacies, and other approved healthcare organizations. Additional terms, minimums, shipping charges, resale requirements, and applicable taxes may apply. Program terms are being finalized and professional checkout will be activated once policies are confirmed.

Request Professional Purchasing Information Speak With the Novilora Professional Team

Application

Request a Professional Account

Please do not submit protected health information (PHI) or patient-identifying information through this form.

Clinical use

Considerations for Clinical Practice

Novilora™ is a nutritional supplement and not a substitute for medical evaluation, diagnostic assessment, or individualized management of peripheral neuropathy.

Before recommending a nutritional supplement, clinicians should consider the patient's diagnosis, current and previous antineoplastic therapy, symptom onset and distribution, concomitant medications and supplements, allergies, dietary requirements, comorbidities, and other potential causes of peripheral neuropathy.

Patients experiencing new, progressive, severe, asymmetric, or otherwise atypical neurologic symptoms should receive appropriate medical evaluation.

[NEEDS CONFIRMATION: COMPLETE INGREDIENT LIST, SUPPLEMENT FACTS, ALLERGEN INFORMATION, AND FINAL SAFETY MATERIALS]

Professional FAQ

Frequently Asked Questions for Clinicians

Is Novilora™ a pharmaceutical product?+

No. Novilora™ is a nutritional supplement and does not require a prescription. It is not FDA approved as a drug and is not intended to diagnose, treat, cure, or prevent disease.

What is the relationship between Novilora™ and OnLife®?+

Novilora™ is the registered U.S. product name for the formulation known in Europe as OnLife®. The formulation was developed in Italy and has been commercially available through European distribution channels.

What clinical evidence is available?+

The principal published evidence includes the prospective, multicenter STEFANO observational study of 146 adults with CIPN following paclitaxel- or oxaliplatin-based chemotherapy. The study reported changes in investigator-assessed sensory and motor neuropathy and patient-reported outcomes after three months. Because the study was observational and uncontrolled, the results should not be interpreted as evidence from a randomized, placebo-controlled trial.

Can Novilora™ be used during active chemotherapy?+

The published STEFANO population received OnLife® after completion of the qualifying adjuvant chemotherapy regimens. Decisions concerning use during active treatment should be individualized by the treating clinician after reviewing the complete formulation, the patient's medical status, and concurrent therapy. The published study does not establish safety or effectiveness during active chemotherapy.

How can my practice provide Novilora™ directly to patients?+

Qualified healthcare practices and organizations may apply for a professional purchasing account. Approved accounts can purchase Novilora™ at the listed professional prices and maintain inventory for appropriate patient access, subject to the program's final terms.

Is professional educational material available?+

Yes. The Medical Professional Center will provide links to the published research, a clinician study summary, ingredient information, suggested-use information, and patient educational resources as those materials become available.

FDA statement. These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. Novilora™ is a dietary supplement and not a prescription drug. Clinicians should independently evaluate the appropriateness of any nutritional supplement for an individual patient.