Drugs / NVG-291
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | — | 2022-10-25 | “the U.S. Food and Drug Administration (FDA) has amended the partial clinical hold to permit the inclusion of males and premenopausal females at certain dose levels” nervgen.com ↗ |
| Clinical hold | US (FDA) | — | — | 2021-03-04 | “submitted a comprehensive package of nonclinical studies to the United States Food and Drug Administration (FDA) to address the partial clinical hold” nervgen.com ↗ “A partial clinical hold was placed on NVG-291 by the FDA in March 2020 when adverse dose-dependent reproductive organ toxicity results were observed” nervgen.com ↗ “Although NVG-291 remains under a partial clinical hold, we are pleased that the FDA has now provided us with a path forward” nervgen.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05308953 | May 2021 → Jun 2023 | spinal cord injury | NervGen Pharma | Completed | No outcome recorded |
| Phase 1/21 trial · 1 met primary | ||||||
| Phase 1/2 | NCT05965700 | Aug 2023 → Dec 2025 | spinal cord injury | NervGen Pharma | Completed | Met primary |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2026-05-26 | NervGen Pharma | Results NervGen Announces Positive Independent, Blinded Biomechanical Gait Analyses Demonstrating Genuine Neural Recovery with NVG-291 in Phase 1b/2a CONNECT SCI Study nervgen.com ↗
NVG-291 demonstrated statistically significant improvement in gait quality (p=0.0197), based on a Global Statistical Test integrating the established hallmarks of genuine neural recovery into a unified assessment of treatment benefit. |
| 2025-11-24 | NervGen Pharma | Results NervGen Pharma Announces Expanded CONNECT SCI Study Data Demonstrating Unprecedented Durable Improvement in Function, Independence, and Quality of Life in Chronic Spinal Cord Injury nervgen.com ↗
Week 16 follow-up data, coupled with blinded exit interviews conducted up to 364 days after the study period, confirm durable and wide-ranging upper and lower-body improvements compared to placebo |
| 2025-08-21 | NervGen Pharma | Results NervGen Pharma’s NVG-291-R Demonstrates Significant Functional Recovery in Department of Defense-Sponsored Preclinical Models of Traumatic Hearing Loss and Peripheral Nerve Injury nervgen.com ↗ |
| 2025-06-02 | NervGen Pharma | Results NervGen Pharma Reports Positive Topline Data from the Chronic Cohort of its Phase 1b/2a Clinical Trial Evaluating NVG-291 in Spinal Cord Injury nervgen.com ↗
Study met its primary endpoint by achieving statistical significance on one of its two pre-specified co-primary endpoints, demonstrating increased electrical connectivity between the brain and hand muscle in individuals with a cervical level spinal cord injury (SCI). |
| 2025-03-31 | NervGen Pharma | Regulatory NervGen Initiates Expanded Access Policy nervgen.com ↗
After the company submitted an expanded access protocol for NVG-291 to the FDA, the FDA informed the company that the study could proceed. |
| 2023-10-23 | NervGen Pharma | Regulatory NervGen Pharma Receives Fast Track Designation for NVG-291 for the Treatment of Individuals with Spinal Cord Injury nervgen.com ↗ |
| 2023-06-27 | NervGen Pharma | Regulatory NervGen Pharma to Receive More Than US$3 Million from Wings for Life to Support Upcoming Clinical Study in Spinal Cord Injury nervgen.com ↗
Additionally, the U.S. Food and Drug Administration (FDA) has completed their review of the Company’s clinical trial protocol and has determined that the study may proceed. |
| 2022-10-25 | NervGen Pharma | Regulatory NervGen Pharma Receives FDA Authorization to Expand Enrollment of Males and Premenopausal Females in Phase 1 Clinical Trial of NervGen’s NVG-291 nervgen.com ↗ |
| 2022-07-28 | NervGen Pharma | Results NervGen Pharma’s NVG-291-R Demonstrates Significant Functional Repair from a Stroke 7 Days After Onset in Landmark Preclinical Study by University of Cincinnati and Case Western Reserve University nervgen.com ↗ |
| 2022-05-12 | NervGen Pharma | Results NervGen Pharma Receives Approval to Proceed to the Final Dose Cohort in Phase 1 Clinical Trial of NVG-291 and Reports Q1 2022 Results nervgen.com ↗
As with our other cohorts, we did not have any adverse events reported in this cohort that were either serious or severe. |
| 2022-03-31 | NervGen Pharma | Results NervGen Presenting Interim Phase 1 Clinical Trial Data for NVG-291 at the 2022 American Academy of Neurology Annual Meeting nervgen.com ↗
Moreover, it is very encouraging that the day 1 and day 14 pharmacokinetic characteristics for NVG-291 at the tested dose level were very similar to each other and to those for the same dose level in the SAD portion of the Phase 1 study. |
| 2022-02-28 | NervGen Pharma | Results NervGen Pharma Reports 2021 Year End Results and Provides Update on Phase 1 Study nervgen.com ↗
We are very encouraged by the fact that there have been no serious adverse events reported to date in the MAD cohort. |
| 2021-12-22 | NervGen Pharma | Regulatory NervGen Pharma Receives Ethics Board Approval for Multiple Ascending Dose Portion of NVG-291 Phase 1 Trial nervgen.com ↗ |
| 2021-11-04 | NervGen Pharma | Results NervGen Presents Additional Phase 1 Clinical Trial Data for NVG-291 at Neuroscience 2021 / Safety Review Committee Provides Recommendation to Proceed to Multiple Ascending Dose Portion of the Trial nervgen.com ↗
NervGen’s Chief Medical Officer, Dr. Daniel Mikol, presented blinded safety and pharmacokinetic data, including new data for the highest single ascending dose (SAD) cohort that demonstrated that NVG-291 was well tolerated and had favorable pharmacokinetic properties. |
| 2021-10-18 | NervGen Pharma | Results NervGen Presents Interim Phase 1 Clinical Trial Data for NVG-291 at the American Neurological Association 146th Annual Meeting / NVG-291 Demonstrated to be Well Tolerated Along with a Favorable Pharmacokinetic Profile nervgen.com ↗
NervGen’s Chief Medical Officer, Dr. Daniel Mikol, presented interim blinded data from the single ascending dose (SAD) cohort of the study that demonstrated that NVG-291 was well tolerated and had favorable pharmacokinetic properties. |
| 2021-04-14 | NervGen Pharma | Regulatory NervGen Pharma Receives Ethics Approval to Initiate Phase 1 Clinical Trial for NVG-291 / Remains on Track to Dose First Subjects in Q2 2021 nervgen.com ↗ |
| 2021-03-08 | NervGen Pharma | Regulatory NervGen Pharma Receives Orphan Designation from the European Medicines Agency for NVG-291 for the Treatment of Spinal Cord Injury nervgen.com ↗
today announced the European Medicines Agency (“EMA”) has granted Orphan Designation for the treatment of spinal cord injury (“SCI”) to NVG-291, a specific and selective protein tyrosine phosphatase sigma (“PTPσ”) inhibitor. |
| 2021-03-04 | NervGen Pharma | Regulatory NervGen Pharma Provides Regulatory Update on Development Program for NVG-291 / Plans to Dose First Human Subjects in Phase 1 in Q2 2021 nervgen.com ↗
The U.S. Food and Drug Administration (“FDA”) has provided feedback regarding our NVG-291 IND submission that allows us to proceed into a Phase 1 healthy volunteer study, |
| 2019-07-10 | NervGen Pharma | Results NervGen Pharma’s Multiple Sclerosis Development Program Targeting Nerve Remylenation Supported by Publication of Independent Peer Reviewed Paper nervgen.com ↗
The peer reviewed paper, “Modulating Proteoglycan Receptor PTPσ Using Intracellular Sigma Peptide Improves Remyelination and Functional Recovery in Mice with Demyelinated Optic Chiasm”, reported that treatment with ISP resulted in the following: remyelination of the optic nerve; reduced LPC induced gliosis and demyelination; increased newly generated oligodendrocyte lineage cells and remyelination; |
All press releases naming this drug 45 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | NVG-291 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05308953 ↗ |
| Route | Subcutaneous | “NVG-291 is a drug injected under the skin (subcutaneous).” NCT05308953 ↗ |