Enovid (nitric oxide nasal spray) / SaNOtize - LARVOL DELTA

NONS-RARS-01: Evaluation of Nitric Oxide Nasal Spray (NONS) for Treatment of Recurrent Acute Rhinosinusitis (clinicaltrials.gov) - P2 | N=162 | Active, not recruiting | Sponsor: Sanotize Research and Development corp. | Trial primary completion date: Aug 2024 ➔ Feb 2025

Trial primary completion date • Otorhinolaryngology • Respiratory Diseases • Sinusitis

NONS-RARS-01: Evaluation of Nitric Oxide Nasal Spray (NONS) for Treatment of Recurrent Acute Rhinosinusitis (clinicaltrials.gov) - P2 | N=162 | Active, not recruiting | Sponsor: Sanotize Research and Development corp. | Recruiting ➔ Active, not recruiting

Enrollment closed • Otorhinolaryngology • Respiratory Diseases • Sinusitis

NONS-RARS-01: Evaluation of Nitric Oxide Nasal Spray (NONS) for Treatment of Recurrent Acute Rhinosinusitis (clinicaltrials.gov) - P2 | N=186 | Recruiting | Sponsor: Sanotize Research and Development corp. | Trial completion date: Sep 2024 ➔ Feb 2025

Trial completion date • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Nitric Oxide Releasing Solution (NORS) For The Treatment Of Human Papillomavirus(HPV) Verrucae Plantaris (Plantar Warts) (clinicaltrials.gov) - P2 | N=20 | Completed | Sponsor: Sanotize Research and Development corp. | Recruiting ➔ Completed | N=30 ➔ 20

Enrollment change • Trial completion • Dermatology • Oncology

NONS-RARS-01: Evaluation of Nitric Oxide Nasal Spray (NONS) for Treatment of Recurrent Acute Rhinosinusitis (clinicaltrials.gov) - P2 | N=186 | Recruiting | Sponsor: Sanotize Research and Development corp.

New P2 trial • Otorhinolaryngology • Respiratory Diseases • Sinusitis

Nitric Oxide Releasing Solution (NORS) For The Treatment Of Human Papillomavirus(HPV) Verrucae Plantaris (Plantar Warts) (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Sanotize Research and Development corp. | Phase classification: P2a ➔ P2 | Trial completion date: Dec 2023 ➔ Mar 2024

Phase classification • Trial completion date • Dermatology • Oncology

Nitric Oxide Releasing Solution (NORS) For The Treatment Of Human Papillomavirus(HPV) Verrucae Plantaris (Plantar Warts) (clinicaltrials.gov) - P2a | N=30 | Recruiting | Sponsor: Sanotize Research and Development corp. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Oncology

Nitric Oxide Footbath for Treatment of Diabetic Foot Ulcers (clinicaltrials.gov) - P1/2 | N=40 | Completed | Sponsor: Sanotize Research and Development corp. | Recruiting ➔ Completed

Trial completion

Nitric Oxide Releasing Solution (NORS) For The Treatment Of Human Papillomavirus(HPV) Verrucae Plantaris (Plantar Warts) (clinicaltrials.gov) - P2a | N=30 | Not yet recruiting | Sponsor: Sanotize Research and Development corp.

New P2a trial • Dermatology • Oncology

Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection (clinicaltrials.gov) - P3 | N=1389 | Active, not recruiting | Sponsor: Sanotize Research and Development corp. | Trial completion date: Jul 2023 ➔ Apr 2024 | Trial primary completion date: Jul 2023 ➔ Jan 2024

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection (clinicaltrials.gov) - P3 | N=1389 | Active, not recruiting | Sponsor: Sanotize Research and Development corp. | Recruiting ➔ Active, not recruiting | N=13000 ➔ 1389 | Trial completion date: Nov 2022 ➔ Jul 2023 | Trial primary completion date: Nov 2022 ➔ Jul 2023

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Nitric Oxide Footbath for Treatment of Diabetic Foot Ulcers (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Sanotize Research and Development corp. | Trial completion date: Dec 2022 ➔ Mar 2023 | Trial primary completion date: Dec 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date

"sanOtize nitric oxide nasal spray? (Enovid, Fabispray, VirX)" (@MirthWormSlim)

SARS-CoV-2 accelerated clearance using a novel nitric oxide nasal spray (NONS) treatment: A randomised trial. (PubMed, Lancet Reg Health Southeast Asia) - "Funding provided by Glenmark Pharmaceuticals Limited. Study medication provided by SaNOtize."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Nitric Oxide Footbath for Treatment of Diabetic Foot Ulcers (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Sanotize Research and Development corp. | Trial completion date: May 2022 ➔ Dec 2022 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial completion date • Trial primary completion date

Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection (clinicaltrials.gov) - P3 | N=13000 | Recruiting | Sponsor: Sanotize Research and Development corp. | Trial completion date: May 2022 ➔ Nov 2022 | Trial primary completion date: Mar 2022 ➔ Nov 2022

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection (clinicaltrials.gov) - P3 | N=13000 | Recruiting | Sponsor: Sanotize Research and Development corp. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection (clinicaltrials.gov) - P3; N=13000; Not yet recruiting; Sponsor: Sanotize Research and Development corp.

Clinical • New P3 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

"Dr. Alvarez, why did inopulse fail for Covid, but @SanotizeD 's Enovid NO spray seems to work?" (@DoodyGiuliani11)

Novel Coronavirus Disease

"Much better sanotize enovid nitric oxide" (@emmartine)

Nitric Oxide Releasing Solution to Treat and Prevent Exacerbation of Mild COVID-19 Infection (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: Sanotize Research and Development corp.; N=50 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease

SaNOtize Obtains Health Canada Approval to Begin Enrolment for Phase III Trials for COVID-19 Anti-Viral Treatment (Businesswire) - "SaNOtize Research and Development Corporation...received approval from Health Canada to proceed with enrollment of volunteers in Phase III trials following earlier positive Phase II results for its Nitric Oxide Nasal Spray (NONS)...The approval for Phase III trials was granted for both prevention and early treatment separately; SaNOtize will begin enrolment for the prevention trial first....Concurrently, SaNOtize submitted an application for a New Drug Submission under Health Canada’s Interim Order, which allows for the earlier filing of applications and rolling submission of data for drugs that show promise to treat or prevent COVID-19."

Canadian regulatory • New P3 trial • Infectious Disease • Novel Coronavirus Disease

"Israel: SaNotize company - Enovid Anti COVID-19 Nasal Spray @SanotizeD https://t.co/Jvb1dakhr3" (@travelingcooki1)

Infectious Disease • Novel Coronavirus Disease

UK Clinical Trial Confirms SaNOtize’s Breakthrough Treatment for COVID-19 (Businesswire) - P2, N=79; "...SaNOtize’s early treatment for COVID-19 significantly reduced the level of SARS-CoV-2, including in patients with high viral loads. The average viral log reduction in the first 24 hours was 1.362, which corresponds to a decline of about 95%. Within 72 hours, the viral load dropped by more than 99%. The majority of these patients had been infected with the UK variant...There were no adverse health events recorded in the UK trial...SaNOtize is applying to regulatory authorities in the UK and Canada for Emergency Use authorization....NONS accelerated clearance of SARS-CoV-2 by a factor of 16-fold versus the placebo..."

P2 data • Infectious Disease • Novel Coronavirus Disease

Israel and New Zealand Permit Sale of SaNOtize’s Breakthrough Anti-Viral Nasal Spray (Businesswire) - "Biotech company SaNOtize Research & Development Corp., (SaNOtize) today announced that it has received interim approval to sell its Nitric Oxide Nasal Spray (NONS)...to the public in pharmacies in Israel, and has been registered to begin sales of NONS in New Zealand. Manufacturing of NONS, under the brand name Enovid™, has begun in Israel with SaNOtize’s manufacturing partner Ness Ziona-based Nextar Chempharma Solutions Ltd. Enovid is expected to appear on pharmacy shelves in Israel by the summer. In New Zealand, SaNOtize has registered its nasal spray with the New Zealand Medicines and Medical Devices Safety Authority, which permits the company to distribute and sell NONS over the counter immediately."

Commercial • Non-US regulatory • Infectious Disease • Novel Coronavirus Disease