Zyesami inhalation (aviptadil) / Relief Therap, United Therapeutics Corp, Seren Clinical, NRx Pharma, Centurion Pharma, Biophore - LARVOL DELTA

Inhaled Aviptadil is a New Hope for Recovery of Lung Damage due to COVID-19. (PubMed, Med Princ Pract) - "Study shows that inhaled aviptadil is well-tolerated and can be used as a supplementary intervention to fasten the recovery of respiratory manifestations in hospitalized patients for COVID-19 pneumonia."

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

The impact of aviptadil as an add-on to the standard of care in acute respiratory distress syndrome (ERS 2024) - "This research underscores the potential of aviptadil as an adjunct treatment in ARDS management, showing notable improvements in oxygenation and a trend toward enhanced survival. Further, larger studies are needed."

Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pancreatitis • Pneumonia • Pulmonary Disease • Respiratory Diseases • Septic Shock

Inhaled Aviptadil is a new hope for recovery of lung damage due to COVID-19 (ERS 2024) - "Inhaled Aviptadil could be a way to treat and fasten the recovery of lungs from COVID-19."

Infectious Disease • Novel Coronavirus Disease

Exploring the Consequences: Severity and Mortality of Hemorrhagic ARDS in Leptospirosis (ERS 2024) - "Early diagnosis is crucial in management of hemorrhagic ARDS in Leptospirosis, which has a significant mortality in Intensive Care settings. Aviptadil does not affect overall mortality, but it significantly improves survival in more severe patients (according to SOFA score), with an increase in the duration of admission."

Acute Respiratory Distress Syndrome • Cough • Hematological Disorders • Infectious Disease • Pulmonary Disease • Respiratory Diseases

A comprehensive history of injection therapy for erectile dysfunction, 1982-2023. (PubMed, Sex Med Rev) - "After 40 years, self-injection therapy represents the medication with the highest efficacy and reliability rates and remains a viable option for many couples with ED. The history of this therapy is rich."

Journal • Erectile Dysfunction

Drugs and natural products for the treatment of COVID-19 during 2020, the first year of the pandemic. (PubMed, Bol Med Hosp Infant Mex) - "These include some that are not considered anti-inflammatory, such as Aviptadil, pyridostigmine bromide, anakinra, imatinib, baricitinib, and bevacizumab, as well as the combination of ivermectin, aspirin, dexamethasone, and enoxaparin...On the other hand, tofacitinib, novaferon with ritonavir, and lopinavir were also effective, as well as in combination with antiviral therapies such as danoprevir with ritonavir. The natural products colchicine and Vitamin D3 were only effective in patients with mild-to-moderate COVID-19, as was hydroxychloroquine. Drug repositioning has been the main tool in the search for effective therapies by expanding the pharmacological options available to patients."

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

I-SPY_COVID: I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients (clinicaltrials.gov) - P2 | N=1500 | Recruiting | Sponsor: QuantumLeap Healthcare Collaborative | Trial completion date: Nov 2024 ➔ Jul 2030 | Trial primary completion date: Jul 2023 ➔ Jul 2028

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

Effect of Aviptadil, a Novel Therapy, on Clinical Outcomes of Patients with Viral-related Severe ARDS: A Retrospective Observational Study. (PubMed, Indian J Crit Care Med) - "Sampley S, Bhasin D, Sekhri K, Singh H, Gupta O. Effect of Aviptadil, a Novel Therapy, on Clinical Outcomes of Patients with Viral-related Severe ARDS: A Retrospective Observational Study. Indian J Crit Care Med 2024;28(1):70-74."

Clinical data • Journal • Observational data • Retrospective data • Acute Respiratory Distress Syndrome • Critical care • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Aviptadil as a Promising Intervention: A Case Study for Transfusion-Related Acute Lung Injury Treatment in a Cardiac Patient. (PubMed, J Cardiothorac Vasc Anesth) - No abstract available

Journal • Acute Lung Injury • Respiratory Diseases

I-SPY_COVID: I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients (clinicaltrials.gov) - P2 | N=1500 | Recruiting | Sponsor: QuantumLeap Healthcare Collaborative | Trial completion date: Nov 2023 ➔ Nov 2024

Trial completion date • Infectious Disease • Novel Coronavirus Disease

Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS (clinicaltrials.gov) - P2 | N=83 | Terminated | Sponsor: Prof. Dr. Jörg Leuppi | N=132 ➔ 83 | Trial completion date: Dec 2023 ➔ Jun 2023 | Recruiting ➔ Terminated | Trial primary completion date: Nov 2023 ➔ Jun 2023; Difficulties recruiting participants for the Aviptadil study as there are nowadays very few hospitalized COVID patients. Continuous screening has been carried out but none of the patients met the eligibility criteria for the study.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease

Peptiligase, an enzyme for efficient chemo-enzymatic synthesis of aviptadil. (PubMed, Int J Biol Macromol) - "The overall time of ligation is shorter than those peptides with similar lengths and hinderance to aviptadil which reported for conventional synthesis by full solid-phase peptide synthesis. Yields ranged from 54 % to 76 %."

Journal • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

Aviptadil: A promising treatment option for acute respiratory distress syndrome. (PubMed, Indian J Tuberc) - No abstract available

Journal • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

HOPE: A Clinical Study Evaluating Inhaled Aviptadil on COVID-19 (clinicaltrials.gov) - P2 | N=80 | Completed | Sponsor: Centurion Pharma | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Potential Value of the Radiographic Assessment of Lung Edema (RALE) Score to Assess Resolution of Pulmonary Edema in a Clinical Trial in ARDS (ATS 2023) - "In a trial of Aviptadil for treatment of COVID-19 respiratory failure, treatment with Aviptadil was associated with significant improvement in RALE score at Day 3 versus placebo. In the context of the observed improvement in 60-day survival and PaO2/FiO2 ratio over 7 days in the parent trial, these findings support the utility of RALE as a clinical trial outcome measure to assess resolution of pulmonary edema."

Clinical • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

"AVIPTADIL" (@SlikeBob)

Relief Therapeutics Announces Positive 12-Month Stability Data for Inhaled and Intravenous Preparations of RLF-100 (Issuer Direct) - "RELIEF THERAPEUTICS...today announced positive 12-month stability data for the liquid and lyophilized preparations of RLF-100 ® , intended for intravenous (IV) and inhaled administration. RLF-100 ® is the company's proprietary, investigational formulation of aviptadil acetate....Relief Therapeutics intends to amend its previously filed provisional patent application for RLF-100 ® with the new findings. If granted, this patent could provide exclusivity for RLF-100 ® at least until 2042, without considering Hatch-Waxman extensions or other patent term adjustments. The Hatch-Waxman Act permits a patent extension term of up to five years as compensation for patent term lost during the FDA regulatory review process."

Clinical data • Patent • Idiopathic Pulmonary Fibrosis

"#Aviptadil ....find the story" (@MrHOIDman)

"Where are the results from the Remdesivir vs Aviptadil NIH trial? What are they hiding? #Aviptadil #Remdesivir" (@MrHOIDman)

Inhaled Aviptadil for the Treatment of COVID-19 in Patients at High Risk for ARDS (clinicaltrials.gov) - P2 | N=132 | Recruiting | Sponsor: Prof. Dr. Jörg Leuppi | N=82 ➔ 132 | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Nov 2022 ➔ Nov 2023

Enrollment change • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • CRP

AVINALI: Inhaled ZYESAMI™ (Aviptadil Acetate) for the Treatment of Severe COVID-19 (clinicaltrials.gov) - P2/3 | N=144 | Terminated | Sponsor: APR Applied Pharma Research s.a. | Recruiting ➔ Terminated; Sponsor decision

Trial termination • Acute Lung Injury • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

"https://t.co/Lt9sWV32mQ India must be having great results with #Aviptadil" (@MrHOIDman)

"Covid deaths yesterday: India= 1 USA= 634 India= #Aviptadil approved USA= #Aviptadil NOT approved" (@MrHOIDman)

Novel Coronavirus Disease

"Have you heard of #Aviptadil ?" (@MrHOIDman)

"India agrees. #aviptadil https://t.co/iIrISo1SNt" (@kdkrietemeyer)