Vivani Medical Provides Update on Clinical Development Plans for NPM-139 Semaglutide Implant for Chronic Weight Management
Vivani Medical (Nasdaq: VANI) has announced plans to initiate clinical trials for NPM-139, their semaglutide implant for chronic weight management. The company plans to begin a Phase 1 study in the first half of 2026, pending regulatory clearance, followed by a Phase 2 study.
The NPM-139 implant, utilizing NanoPortal™ technology, aims to provide Wegovy®-level efficacy with just once or twice-yearly administration. The Phase 1 study will evaluate safety, tolerability, and pharmacokinetics in GLP-1 naïve obese or overweight subjects, with low-dose Wegovy as control. The subsequent Phase 2 study will be a randomized, placebo-controlled, dose-ranging investigation over 4-6 months.
Vivani Medical (Nasdaq: VANI) ha annunciato l'intenzione di avviare studi clinici per NPM-139, il loro impianto a base di semaglutide per la gestione cronica del peso. L'azienda prevede di iniziare uno studio di Fase 1 nella prima metà del 2026, soggetto all'approvazione regolatoria, seguito da uno studio di Fase 2.
L'impianto NPM-139, che sfrutta la tecnologia NanoPortal™, mira a offrire un'efficacia paragonabile a Wegovy® con somministrazioni una o due volte l'anno. Lo studio di Fase 1 valuterà sicurezza, tollerabilità e farmacocinetica in soggetti obesi o sovrappeso naïve al GLP-1, usando una bassa dose di Wegovy come controllo. Il successivo studio di Fase 2 sarà uno studio randomizzato, controllato con placebo e a dosi variabili, della durata di 4-6 mesi.
Vivani Medical (Nasdaq: VANI) ha anunciado su intención de iniciar ensayos clínicos para NPM-139, su implante de semaglutida para el manejo crónico del peso. La compañía planea comenzar un estudio de Fase 1 en la primera mitad de 2026, pendiente de la aprobación regulatoria, seguido de un estudio de Fase 2.
El implante NPM-139, que utiliza la tecnología NanoPortal™, tiene como objetivo ofrecer una eficacia similar a Wegovy® con una o dos administraciones al año. El estudio de Fase 1 evaluará la seguridad, la tolerabilidad y la farmacocinética en sujetos obesos o con sobrepeso sin experiencia previa con agonistas de GLP-1, con una dosis baja de Wegovy como control. El posterior estudio de Fase 2 será aleatorizado, controlado con placebo y explorará diferentes dosis durante 4-6 meses.
Vivani Medical (Nasdaq: VANI)는 만성 체중 관리를 위한 세마글루타이드 임플란트 NPM-139의 임상시험 착수를 발표했습니다. 회사는 규제 승인에 따라 2026년 상반기 중 1상 연구를 시작하고, 이후 2상 연구를 진행할 계획입니다.
NanoPortal™ 기술을 적용한 NPM-139 임플란트는 연간 1~2회 투여로 Wegovy® 수준의 효능을 제공하는 것을 목표로 합니다. 1상 연구는 GLP-1 치료 경험이 없는 비만 또는 과체중 대상자에서 안전성, 내약성 및 약동학을 평가하며 저용량 Wegovy를 대조군으로 사용합니다. 이어질 2상 연구는 무작위 배정, 위약 대조, 용량 탐색 방식으로 4~6개월 동안 진행됩니다.
Vivani Medical (Nasdaq: VANI) a annoncé son intention de lancer des essais cliniques pour NPM-139, son implant de sémaglutide destiné à la prise en charge chronique du poids. La société prévoit de démarrer une étude de phase 1 au premier semestre 2026, sous réserve des autorisations réglementaires, puis une phase 2.
L'implant NPM-139, utilisant la technologie NanoPortal™, vise à offrir une efficacité comparable à Wegovy® avec une administration une à deux fois par an. L'étude de phase 1 évaluera la sécurité, la tolérabilité et la pharmacocinétique chez des sujets obèses ou en surpoids naïfs au GLP-1, avec une faible dose de Wegovy en contrôle. L'étude de phase 2 suivante sera randomisée, contre placebo et explorera plusieurs doses sur 4 à 6 mois.
Vivani Medical (Nasdaq: VANI) hat Pläne angekündigt, klinische Studien für NPM-139, ihr Semaglutid-Implantat zur langfristigen Gewichtsregulierung, zu starten. Das Unternehmen beabsichtigt, in der ersten Hälfte 2026 eine Phase-1-Studie zu beginnen, vorbehaltlich der behördlichen Freigabe, gefolgt von einer Phase-2-Studie.
Das NPM-139-Implantat nutzt die NanoPortal™-Technologie und zielt darauf ab, eine Wirksamkeit auf Wegovy®-Niveau bei nur ein- bis zweimal jährlicher Verabreichung zu bieten. Die Phase-1-Studie wird Sicherheit, Verträglichkeit und Pharmakokinetik bei GLP-1-naiven adipösen oder übergewichtigen Probanden untersuchen; eine niedrige Wegovy-Dosis dient als Kontrolle. Die anschließende Phase-2-Studie ist eine randomisierte, placebokontrollierte Dosisfindungsstudie über 4–6 Monate.
- Potential for Wegovy-level efficacy with significantly reduced administration frequency (once/twice yearly vs. weekly)
- Building on promising results from LIBERATE-1 study of similar technology (NPM-115 exenatide implant)
- Potential for improved tolerability due to reduced drug fluctuations and eliminated missed doses
- Targeting large and growing GLP-1 weight management market with unique implant solution
- Clinical trials won't begin until first half of 2026
- Success depends on pending regulatory clearances
- Faces competition in crowded GLP-1 market
- No clinical efficacy data available yet for NPM-139
Insights
Vivani's semaglutide implant NPM-139 enters clinical pipeline with Phase 1 trials planned for H1 2026, targeting the lucrative GLP-1 obesity market.
Vivani Medical is advancing its NPM-139 semaglutide implant into clinical development, with a Phase 1 study expected to begin in the first half of 2026. This represents a significant milestone in the company's pipeline progression. The technology leverages Vivani's NanoPortal™ platform, which has already shown promising results in their first-in-human LIBERATE-1 study with a different GLP-1 compound (exenatide).
The company's strategic approach is noteworthy - they're preparing for Phase 2 studies in parallel with Phase 1, indicating confidence in their technology and a desire to accelerate development timelines. The Phase 1 study will focus on safety, tolerability and pharmacokinetics in GLP-1-naïve subjects who are obese or overweight, with Wegovy as a control arm. The subsequent Phase 2 will be a dose-ranging study over 4-6 months.
Vivani's key differentiation centers on administration frequency - they're targeting once or twice-yearly dosing while maintaining Wegovy-level efficacy. This could address significant adherence challenges with current weekly injectable GLP-1s. Additionally, the consistent drug release profile may potentially reduce the gastrointestinal side effects commonly associated with GLP-1 therapies, which typically result from concentration fluctuations after each bolus injection.
The timing is strategic, as semaglutide's therapeutic potential continues expanding beyond diabetes and weight management into areas like MASH (recently approved) and Alzheimer's (pending Phase 3 results). If successful, Vivani would establish itself as the only implantable option in an increasingly crowded GLP-1 market, potentially accessing market segments underserved by current formulations.
NPM-139 has potential to provide Wegovy®-level efficacy with once or twice-yearly administration
First-in-human Phase 1 study is expected to initiate in the first half of 2026, pending regulatory clearance
Preparations for dose-ranging Phase 2 study of NPM-139 to occur in parallel with Phase 1 study
ALAMEDA, Calif., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Vivani Medical, Inc. (Nasdaq: VANI) (“Vivani” or the “Company”), a clinical-stage biopharmaceutical company developing novel, ultra long-acting drug implants, today announced plans to initiate a Phase 1 clinical study in the NPM-139 semaglutide implant program in the first half of 2026, pending regulatory clearance. The Company is also preparing to initiate a Phase 2 clinical study of NPM-139 pending enabling results from the Phase 1 study and regulatory feedback. The NPM-139 clinical program will evaluate the Company’s investigational semaglutide implant for chronic weight management in patients who are either obese or overweight with a related comorbidity.
“Recent promising results from LIBERATE-1™, the first-in-human study of NPM-115, an exenatide implant utilizing NanoPortal™ technology, combined with positive preclinical weight loss data with NPM-139, compel us to move forward aggressively with clinical development of NPM-139. The Phase 1 study, designed to evaluate the safety, tolerability and pharmacokinetic profile of the semaglutide implant and to enable a Phase 2 efficacy study, is expected to initiate in the first half of 2026, pending regulatory clearance,” said Vivani President and Chief Executive Officer Adam Mendelsohn, Ph.D. “The overall GLP-1 market in weight management continues to grow at an impressive rate, primarily because of considerable unmet medical needs and the fact that current GLP-1 options have a much better safety and efficacy profile compared to medications previously approved to treat obesity. We believe that NPM-139 could provide clear and compelling differentiation due to its potential to provide Wegovy®-level efficacy with convenient once or twice-yearly administration. Having recently obtained approval for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and with an expected near-term Phase 3 readout in the treatment of Alzheimer’s disease, semaglutide-based products continue to demonstrate tremendous potential to treat chronic diseases, and we believe the therapeutic potential of semaglutide could be significantly enhanced with an option that enables once or twice-yearly administration.”
Dr. Mendelsohn continued, “If clinically validated and approved, we expect our products to stand out in a crowded and competitive field as the only available implant which could potentially enable providers to address new and currently underserved market segments. In addition, we continue to believe that NPM-139 could demonstrate improved tolerability relative to currently available oral or injectable GLP-1 medications, both because of the avoidance of drug fluctuations at each administration of oral or injectable options which provide each dose as a bolus, and by eliminating missed doses that further exacerbate the dosing fluctuations which are largely responsible for the gastrointestinal side effects of GLP-1 treatments.”
Clinical Program for Semaglutide Implants for Chronic Weight Management
The first clinical study of NPM-139 is planned as a small Phase 1 randomized, controlled investigation of the safety, tolerability and pharmacokinetic profile of the semaglutide NanoPortal implant in GLP-1 naïve obese or overweight subjects. The planned control arm is low-dose Wegovy injected weekly. The semaglutide implant to be used in this study is expected to produce comparable semaglutide exposure levels to low dose Wegovy injections. This study is expected to be initiated in the first half of 2026, pending regulatory clearance.
The design of the second clinical study will be finalized pending results from the Phase 1 study but is anticipated to be a Phase 2, randomized, placebo-controlled, dose-ranging investigation over 4 to 6 months to evaluate the effects of the semaglutide NanoPortal implant on weight management in obese or overweight subjects. This study will provide safety, efficacy, and dose selection information for Phase 3 and will initiate shortly after Phase 1 completes, if warranted by the Phase 1 results and pending regulatory clearance.
About Vivani Medical, Inc.
Leveraging its proprietary NanoPortal™ platform, Vivani develops biopharmaceutical implants designed to deliver drug molecules steadily over extended periods of time with the goal of guaranteeing adherence and improving patient tolerance to their medication. Vivani is developing a portfolio of GLP-1 based implants for chronic weight management and other metabolic diseases including type 2 diabetes. These NanoPortal implants are designed to provide patients with the opportunity to realize the full potential benefit of their medication by avoiding the numerous challenges associated with the daily or weekly administration of orals and injectables, including tolerability issues and loss of efficacy. Medication non-adherence occurs when patients do not take their medication as prescribed. This affects an alarming number of patients, approximately
Forward-Looking Statements
This press release contains certain “forward-looking statements” within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “target,” “believe,” “expect,” “will,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” and other similar expressions that in this press release, including statements regarding Vivani’s business, products in development, including the therapeutic potential thereof, the planned development therefor, the completion of the LIBERATE-1 Phase 1 study and reporting of study results, Vivani’s emerging development plans for NPM-139, NPM-115 or Vivani’s plans with respect its technology, strategy, cash position and financial runway. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on Vivani’s current beliefs, expectations, and assumptions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of Vivani’s control. Actual results and outcomes may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results and outcomes to differ materially from those indicated in the forward-looking statements include, among others, risks related to the development and commercialization of Vivani’s products, including NPM-139 and NPM-115; delays and changes in the development of Vivani’s products, including as a result of applicable laws, regulations and guidelines, potential delays in submitting and receiving regulatory clearance or approval to conduct Vivani’s development activities, including Vivani’s ability to commence clinical development of NPM-139; risks related to the initiation, enrollment and conduct of Vivani’s planned clinical studies and the results therefrom; or Vivani’s history of losses and Vivani’s ability to access additional capital or otherwise fund Vivani’s business. There may be additional risks that the Company considers immaterial, or which are unknown. A further list and description of risks and uncertainties can be found in the Company’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 31, 2025, as updated by the Company’s subsequent Quarterly Reports on Form 10-Q. Any forward-looking statement made by Vivani in this press release is based only on information currently available to the Company and speaks only as of the date on which it is made. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of added information, future developments or otherwise, except as required by law.
Company Contact:
Donald Dwyer
Chief Business Officer
info@vivani.com
(415) 506-8462
Investor Relations Contact:
Jami Taylor
Investor Relations Advisor
investors@vivani.com
(415) 506-8462
Media Contact:
Sean Leous
Senior Vice President
ICR Healthcare
Sean.Leous@ICRHealthcare.com
(646) 866-4012
FAQ
When will Vivani Medical (VANI) begin Phase 1 trials for NPM-139?
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