Nasus Pharma Announces Enrollment and Dosing of First Patient in Phase 1 Study of NS003 Intranasal Formulation of Ondansetron
The first human NS003 results are still ahead, following animal studies that compared its drug exposure with intravenous ondansetron.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Nasus Pharma (NSRX) has enrolled and dosed the first patient in a Phase 1 study of intranasal NS003. The first-in-human study will assess drug concentrations over time and safety. NS003 is a nasal powder formulation of ondansetron being developed for chemotherapy-induced and post-operative nausea and vomiting.
In an animal study, NS003 had a drug-exposure profile comparable to intravenous ondansetron, including similar time to peak concentration and overall exposure. A separate safety study found no adverse effects at four times the test dose. Nasus Pharma anticipates topline results from the Phase 1 study in the fourth quarter of 2026. The company also targets that quarter to begin a pivotal study of NS002 for anaphylaxis.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointFirst patient enrolled and dosed in NS003’s Phase 1 pharmacokinetic study.
- Moderate point. Forward-looking: it has not happened yet and may not happen.NS002 pivotal study is targeted to begin in the fourth quarter of 2026.
- Minor pointAnimal study found an NS003 drug-exposure profile comparable to intravenous ondansetron.
- Minor pointSeparate safety study observed no adverse effects at four times the test dose.
- Minor point. Forward-looking: it has not happened yet and may not happen.NS003 topline results are anticipated in the fourth quarter of 2026.
Negative
- None.
Details
Market Reaction – NSRX
On Sep 29, the day this news came out, the latest delayed price for NSRX is 1.11% below the previous close. Our momentum scanner has recorded 3 alerts for this stock so far that day. The latest delayed price is $3.55.
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Key Figures
- Topline PK data timing
- Fourth quarter of 2026
- NS003 Phase 1 study
- Safety-study dose
- Four times the test dose
- Preclinical NS003 safety study; no adverse effects observed
Previous Clinical trial Reports
-
Company said NS003 was advancing toward first-in-human studies during H2 2026.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
pharmacokinetic medical
tmax medical
auc medical
cinv medical
ponv medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Topline Data from First-in-Human Pharmacokinetic Study Anticipated in the Fourth Quarter of 2026
TEL AVIV, Israel, Sept. 29, 2026 (GLOBE NEWSWIRE) -- Nasus Pharma Ltd. (NYSE: NSRX) (“Nasus Pharma” or the “Company”), a clinical-stage pharmaceutical company focused on the development of innovative intranasal products, today announced that the first patient has been enrolled and dosed in the Company’s Phase 1 pharmacokinetic (PK) trial of NS003, its proprietary intranasal powder formulation of ondansetron being developed for chemotherapy-induced nausea and vomiting (CINV) and post-operative nausea and vomiting (PONV).
In a recent pre-clinical study comparing NS003 to the intravenous (“IV”) formulation of ondansetron in animals, results showed that NS003 had a PK profile comparable to the IV formulation, with similar time to maximum concentration (Tmax) and area under the curve (AUC) results. In a separate safety study, NS003 demonstrated a favorable safety profile at four times the test dose, with no adverse effects observed. The current Phase 1 PK study will assess the pharmacokinetic and safety profile of NS003 in human patients for the first time.
"Enrolling and dosing our first patient in this Phase 1 study of NS003 demonstrates our ability to execute on previous guidance, and we are very pleased to achieve this milestone," said Brendan O'Grady, Chief Executive Officer of Nasus. "Ondansetron remains one of the most widely prescribed anti-emetics, with significant usage of the IV formulation in the hospital setting. A fast-onset, needle-free option could offer real value for patients who aren't fully controlled on oral therapy. Intranasal administration of NS003 has the potential to address these unmet needs by offering a convenient, fast-onset alternative that may reduce avoidable clinic visits. We look forward to announcing topline PK data from this study before year-end, along with the initiation of our pivotal NS002 study for anaphylaxis, also targeted for the fourth quarter."
Ondansetron is one of the most widely used therapies for chemotherapy-induced nausea and vomiting. In 2023, more than 12 million prescriptions for orally administered were dispensed to over 6 million patients. Zofran®(ondansetron) peak sales exceeded
About Nasus Pharma
Nasus Pharma is a clinical-stage pharmaceutical company developing a number of intranasal powder products addressing acute medical conditions in the community. NS002, Nasus Pharma’s intranasal powder Epinephrine product candidate is being developed as a needle-free alternative to Epinephrine autoinjectors for patients with anaphylaxis. Intranasal administration is most suitable for those situations in which rapid drug delivery is required and offers needle-free, easy-to-use alternatives. Nasus Pharma’s proprietary powder-based intranasal (“PBI”) technology is designed for rapid and reliable drug delivery, leveraging the nasal cavity’s rich vascular network for quick absorption. The PBI formulation uses uniform spherical powder particles for broad dispersion and potentially faster, higher absorption compared to liquid-based nasal products. For further information about the Company, please visit www.nasuspharma.com or follow on Twitter (X) or LinkedIn.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other U.S. federal securities laws. Words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will”, “would,” or the negative of these words, similar expressions or variations of such words are intended to identify forward-looking statements. For example, Nasus Pharma is using forward-looking statements in this press release when it discusses: the planned initiation and timing of a first-in-human PK study and Phase 1 trial for NS003, the timing of the NS002 pivotal study, expected clinical and development milestones, and the expansion of the Company’s product portfolio. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Forward-looking statements are based on the Company’s current expectations and are subject to uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the Company’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on March 25, 2026. Forward-looking statements contained in this press release are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.
Corporate Contact
Nasus Pharma Ltd. Israel
info@nasuspharma.com
Investors Contact
Mike Moyer
LifeSci Advisors
+1-617-308-4306
mmoyer@lifesciadvisors.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What will Nasus Pharma’s NS003 Phase 1 study assess, and when are results expected?
The first-in-human study will assess NS003’s pharmacokinetic profile and safety in patients. Nasus Pharma anticipates topline results in the fourth quarter of 2026.
What did Nasus Pharma’s preclinical NS003 studies find?
An animal study found that NS003 had a drug-exposure profile comparable to intravenous ondansetron, with similar time to peak concentration and overall exposure. A separate safety study observed no adverse effects at four times the test dose.