Drugs / RNS60
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT02525471 | Oct 2015 → Jun 2017 | amyotrophic lateral sclerosis | Sabrina Paganoni, M.D. | Completed | No outcome recorded |
| Phase 1 | NCT02490865 | Jul → Aug 2015 | — | Revalesio Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01511302 | Jun 2012 → Apr 2013 | asthma | Revalesio Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01264783 | Jul → Sep 2011 | myocardial infarction | Revalesio Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01057498 | May → Nov 2010 | asthma | Revalesio Corporation | Completed | No outcome recorded |
| Phase 27 trials · 1 met primary | ||||||
| Phase 2 | NCT02988297 | Oct 2026 → Nov 2028 | amyotrophic lateral sclerosis | Revalesio Corporation | Withdrawn | No outcome recorded |
| Phase 2 | NCT04693715 | Jul 2021 → Nov 2023 | ischemic stroke | Revalesio Corporation | Completed | Met primary |
| Phase 2 | NCT02422121 | Apr → Nov 2015 | asthma | Revalesio Corporation | Completed | No outcome recorded |
| Phase 2 | NCT02497222 | ? → Jun 2016 | asthma | Revalesio Corporation | Withdrawn | No outcome recorded |
| Phase 2 | NCT01714089 | — | relapsing-remitting multiple sclerosis | Revalesio Corporation | Withdrawn | No outcome recorded |
| Phase 2 | NCT02005523 | ? → Oct 2014 | — | Revalesio Corporation | Withdrawn | No outcome recorded |
| Phase 2 | NCT01922427 | ? → Oct 2014 | — | Revalesio Corporation | Withdrawn | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT03456882 Comparator | May 2017 → Nov 2020 | amyotrophic lateral sclerosis | Mario Negri Institute for Pharmacological Research | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2025-11-19 | Revalesio Corporation | Results Revalesio to Present Findings from a Post-Hoc Analysis of Phase 2 RESCUE Trial at SVIN 2025, Highlighting RNS60’s Potential to Shorten Hospital Stay revalesio.com ↗
This post hoc analysis further revealed that participants who received RNS60 were more likely to have shorter hospital stays, which shows the potential to improve stroke related healthcare economics. |
| 2025-07-31 | Revalesio Corporation | Regulatory Revalesio Receives FDA Fast Track Designation for RNS60 for the Treatment of Acute Ischemic Stroke revalesio.com ↗
Revalesio, a clinical-stage biopharmaceutical company developing treatments for acute and chronic neurological disorders, today announced that the U.S. Food and Drug Administration has granted Fast Track designation to RNS60, its lead investigational therapy, for the treatment of acute ischemic stroke. |
| 2025-07-21 | Revalesio Corporation | Results Revalesio Announces Publication of RESCUE Phase 2 Trial Results Evaluating RNS60 as an Adjunctive Therapy for Acute Ischemic Stroke in the Journal Stroke revalesio.com ↗
Revalesio, a clinical-stage biopharmaceutical company developing treatments for acute and chronic neurological disorders, today announced the peer-reviewed publication of results from its RESCUE Phase 2 clinical trial evaluating RNS60 as an adjunctive treatment in patients with acute ischemic stroke. |
| 2025-07-14 | Revalesio Corporation | Results Revalesio to Present Phase 3 Trial Design and Post Hoc Analysis of Phase 2 RESCUE trial of RNS60 in Acute Ischemic Stroke at the SNIS 22nd Annual Meeting revalesio.com ↗
“Post Hoc Analysis of RESCUE Shows Improvement in all Prespecified Efficacy Endpoints in Participants Enrolled <12h Since Symptom Onset” will be presented from 12:40-12:45 p.m. CT. |
| 2025-05-21 | Revalesio Corporation | Results Revalesio Presents Additional Analyses from the Phase 2 RESCUE Clinical Trial for RNS60 in Acute Ischemic Stroke revalesio.com ↗
These results were presented today during a poster session at the European Stroke Organisation Conference being held in Helsinki, Finland from May 21-23, 2025. |
| 2025-02-05 | Revalesio Corporation | Results Revalesio Announces New Analyses from Phase 2 RESCUE Study of RNS60 in Patients with Acute Ischemic Stroke in Oral Presentation at the International Stroke Conference 2025 revalesio.com ↗
The lowering of infarct growth correlated with clinically meaningful improvements in several functional stroke measures that evaluate a patient’s recovery, including the modified Rankin Scale (mRS), Barthel Index (BI), and National Institute of Health Stroke Scale (NIHSS). |
| 2024-10-09 | Revalesio Corporation | Results REVALESIO’S INVESTIGATIONAL TREATMENT RNS60 PROTECTS MITOCHONDRIA IN PRECLINICAL MODEL OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) revalesio.com ↗
Revalesio, a clinical-stage pharmaceutical company developing treatments for acute and chronic neurological disorders, today announced new data showing that Revalesio’s investigational therapeutic, RNS60, protected motor neurons in the prpTDP-43-UeGFP mouse model of ALS. |
| 2024-09-17 | Revalesio Corporation | Results REVALESIO’S INVESTIGATIONAL RNS60 EXTENDED SURVIVAL IN PATIENTS WITH AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN POST-HOC ANALYSIS OF PHASE 2 INVESTIGATOR-SPONSORED TRIAL revalesio.com ↗
Median survival was 6 months longer in the RNS60 group compared to placebo (3 years vs. 2.4 years, p = 0.0519). |
| 2024-02-07 | Revalesio Corporation | Results REVALESIO ANNOUNCES POSITIVE TOPLINE DATA FROM PHASE 2 RESCUE STUDY OF RNS60 IN PATIENTS WITH ACUTE ISCHEMIC STROKE IN LATE-BREAKING ORAL PRESENTATION AT ISC 2024 revalesio.com ↗
RNS60 met its primary endpoints in RESCUE (safety and mortality) |
| 2021-12-07 | Revalesio Corporation | Results PROMISING CLINICAL DATA ON REVALESIO’S RNS60 PRESENTED AT 32ND INTERNATIONAL SYMPOSIUM ON ALS/MND revalesio.com ↗
While there was no impact of RNS60 on the candidate biomarkers or the ALSFRS-R, there was a statistically significant slowing of decline in lung function, as measured by FVC, in patients receiving RNS60. |
| 2019-01-04 | Revalesio Corporation | Regulatory FDA GRANTS REVALESIO FAST TRACK STATUS FOR ALS INVESTIGATIONAL DRUG RNS60 revalesio.com ↗
Revalesio announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track status for its investigational drug RNS60 as a treatment for amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. |
| 2018-03-06 | Revalesio Corporation | Results RNS60 PROMOTES MYELINATION OF NANOFIBERS BY OLIGODENDROCYTES revalesio.com ↗ |
| 2017-09-20 | Revalesio Corporation | Regulatory FDA GRANTS REVALESIO ORPHAN DRUG STATUS FOR ALS INVESTIGATIONAL DRUG RNS60 revalesio.com ↗
Revalesio announced today that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for the investigational drug RNS60 for the treatment of amyotrophic lateral sclerosis (ALS). |
| 2016-12-22 | Revalesio Corporation | Regulatory FDA ALLOWS REVALESIO’S INVESTIGATIONAL NEW DRUG APPLICATION TO STUDY RNS60 IN ALS revalesio.com ↗
Revalesio received US Food and Drug Administration (FDA) allowance of an Investigational New Drug (IND) application for Phase II clinical testing of RNS60 in patients with amyotrophic lateral sclerosis (ALS). |
| 2014-10-20 | Revalesio Corporation | Results REVALESIO’S RNS60 DEMONSTRATES PROMISE IN TREATING ALZHEIMER’S DISEASE AND OTHER DEMENTIAS revalesio.com ↗
Early RNS60 results from in vitro research and animal studies, coupled with high tolerability experience for both the inhaled and injectable formulations, are very promising and encouraging for all of us at Revalesio. |
| 2014-03-14 | Revalesio Corporation | Results REVALESIO PRESENTS PHASE I HUMAN DATA AT AAAAI revalesio.com ↗
The poster presented by Revalesio was titled “A Phase I Assessment of Safety and Tolerability of RNS60, a Novel Therapeutic Containing Charge-stabilized Nanostructures in Asthma” and demonstrated that RNS60 proved to be safe and well tolerated when nebulized alone or together with budesonide. |
All press releases naming this drug 22 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 14 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RNS60 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03456882 ↗ |
| Modality | Other / unclassified | “RNS60 is a proprietary combination of oxygen supersaturated in saline” PMID 40671649 ↗ Jul 2025 |
| Route | Other | “RNS60, 4ml nebulized twice daily for 15 minutes.” NCT01057498 ↗ |