NeuroSense Therapeutics' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by NeuroSense Therapeutics (NRSN).
Over the past two years, NeuroSense Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
PrimeC. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
PrimeC FDA Regulatory Timeline and Events
PrimeC is a drug developed by NeuroSense Therapeutics for the following indication: Amyotrophic lateral sclerosis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PrimeC
- Announced Date:
- March 9, 2026
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics announced that the recently reported long-term survival data from its Phase 2b PARADIGM trial of PrimeC in amyotrophic lateral sclerosis (ALS) will be presented at a leading scientific conference on March 9, 2026.
AI Summary
NeuroSense Therapeutics announced that long-term survival results from its Phase 2b PARADIGM trial of PrimeC in amyotrophic lateral sclerosis (ALS) will be presented at The Muscular Dystrophy Association (MDA) Clinical & Scientific Conference on March 9, 2026. A Cox proportional hazards analysis showed a statistically significant 65% reduction in risk of death for PrimeC (hazard ratio 0.35, p=0.0037). Kaplan–Meier estimates indicated a greater than 14‑month median survival benefit from randomization (36.3 months versus 21.4 months; log‑rank p=0.0218).
The data will be presented during the “Advancing ALS Therapeutics: Targets, Tools, and Trial Readiness” session by Dr. Jinsy Andrews, a leader in ALS clinical research and member of NeuroSense’s scientific advisory board. NeuroSense said the newly analyzed survival findings strengthen the clinical dataset supporting PrimeC and inform planning for the next-stage, Phase 3 study.
Read Announcement- Drug:
- PrimeC
- Announced Date:
- February 18, 2026
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics Ltd announced the availability of additional long-term survival data from its previously completed PARADIGM Phase 2b clinical trial evaluating PrimeC in patients with amyotrophic lateral sclerosis (ALS).
AI Summary
NeuroSense Therapeutics announced additional long-term survival data from its completed PARADIGM Phase 2b trial of PrimeC in ALS patients. An extended follow-up showed a clinically meaningful and statistically significant improvement in overall survival for those treated with PrimeC compared with patients originally assigned to placebo.
Kaplan–Meier estimates showed median survival of 36.3 months for patients who received PrimeC continuously versus 21.4 months for those who started on placebo and later crossed over — a more than 14‑month gain, roughly a 70% increase. The survival curves remained separated over time (log‑rank p = 0.0218). A Cox model, adjusted for baseline risk, found PrimeC reduced the risk of death by 65% (hazard ratio 0.35; 95% CI 0.17–0.71; p = 0.0037).
NeuroSense said the results support PrimeC’s durable, disease‑modifying potential and strengthen the case for advancing into late‑stage development while engaging with regulatory authorities.
Read Announcement- Drug:
- PrimeC
- Announced Date:
- December 22, 2025
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics today reported completion of the safety analysis from its proof-of-concept Phase 2, randomized, double-blind, placebo-controlled NST-AD-001 study of PrimeC combination in Alzheimer's disease.
AI Summary
NeuroSense Therapeutics announced completion of the safety analysis from its proof-of-concept Phase 2, randomized, double-blind, placebo-controlled NST-AD-001 study of PrimeC in Alzheimer’s disease. The analysis showed a favorable tolerability profile: no serious adverse events were reported and no new or unexpected safety signals were identified.
As an exploratory study, clinical outcome measures are descriptive. NeuroSense will analyze clinical observations together with biomarker data to provide a more complete interpretation of the results. The company expects to report those clinical and biomarker findings in the first quarter of 2026.
PrimeC is an oral extended-release fixed-dose combination of ciprofloxacin and celecoxib, designed to target multiple disease mechanisms tied to neuron degeneration, inflammation, iron accumulation and RNA dysregulation. The study is intended to assess whether this multi-target approach can improve treatment options for people with Alzheimer’s disease.
Read Announcement- Drug:
- PrimeC
- Announced Date:
- November 24, 2025
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics announced that the U.S. Food and Drug Administration (FDA) has completed the review of the Investigational New Drug (IND) amendment application and authorized the Company to initiate the pivotal Phase 3 clinical trial for the evaluation of its lead drug candidate, PrimeC, for the treatment of amyotrophic lateral sclerosis (ALS).
AI Summary
NeuroSense said the U.S. Food and Drug Administration completed its review of the company’s IND amendment and authorized initiation of a pivotal Phase 3 trial of PrimeC for amyotrophic lateral sclerosis (ALS). With FDA clearance, NeuroSense is preparing to start the trial and aims to enroll the first patient in the coming months once it secures the necessary resources.
The global Phase 3 trial, PARAGON, is powered at over 95% for its primary endpoint and will build on NeuroSense’s Phase 2b PARADIGM findings. The study plans to enroll 300 people with ALS randomized 2:1 to PrimeC or placebo in a 12‑month, double‑blind, placebo‑controlled design with an open‑label extension. The adaptive design allows interim analyses to adjust sample size and assess early efficacy or futility.
PrimeC is an oral extended‑release fixed‑dose combination of ciprofloxacin and celecoxib designed to target multiple disease mechanisms. FDA authorization to begin PARAGON is a key step toward testing whether PrimeC can slow ALS progression.
Read Announcement- Drug:
- PrimeC
- Announced Date:
- October 6, 2025
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics Ltd. announced new positive findings based on plasma samples from its Phase-2b PARADIGM study.
AI Summary
NeuroSense Therapeutics Ltd. announced new positive findings from plasma samples in its Phase-2b PARADIGM study of PrimeC, a novel extended-release oral therapy. Results showed that PrimeC treatment led to statistically significant reductions in Alzheimer’s disease–associated microRNAs: miR-146a-5p (p=0.007), miR-21-5p (p=0.003), miR-let-7a-5p (p=0.028) and miR-let-7e-5p (p=0.006). The placebo group showed no meaningful changes.
These microRNAs regulate genes involved in brain inflammation, amyloid and tau buildup, and nerve cell damage. Lowering them suggests PrimeC can directly target key pathways in Alzheimer’s and may act as a disease-modifying therapy.
“These biomarker data provide a clearer view of how our novel combination modulates Alzheimer’s disease pathways,” said Alon Ben-Noon, CEO of NeuroSense. “The magnitude and consistency of the observed miRNA changes are highly encouraging and will inform the design of our follow-on Alzheimer’s study.”
Read Announcement- Drug:
- PrimeC
- Announced Date:
- September 2, 2025
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics Ltd announced a new analysis of 18-month data from its Phase 2b PARADIGM study of PrimeC in ALS.
AI Summary
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Read Announcement- Drug:
- PrimeC
- Announced Date:
- May 7, 2025
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics Ltd. announced that it has successfully scaled-up its production of PrimeC to commercial scale, marking a significant step toward bringing this potential disease-modifying ALS therapy to patients, following the promising efficacy data demonstrated in the Phase 2b PARADIGM study.
AI Summary
NeuroSense Therapeutics Ltd. has reached a major milestone by successfully scaling up its production of PrimeC to a commercial level. This scale-up comes on the heels of promising results from the Phase 2b PARADIGM study, highlighting PrimeC’s potential as a disease-modifying therapy for ALS patients. The achievement builds on robust improvements in their manufacturing process, ensuring that all analytical methods for product release and stability have been fully validated. By partnering with a global Contract Development and Manufacturing Organization (CDMO), NeuroSense secured a dependable supply chain for future production needs. The validated manufacturing process also supports a shelf life of at least 36 months at room temperature. This progress marks a significant step toward bringing PrimeC to market, aiming to address a critical unmet need for new therapeutic options for those suffering from ALS.
Read Announcement - Drug:
- PrimeC
- Announced Date:
- April 24, 2025
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics issued a shareholder letter from Chief Executive Officer Alon Ben-Noon.
AI Summary
NeuroSense Therapeutics’ CEO, Alon Ben-Noon, issued a shareholder letter outlining key developments for the company. In his message, he highlighted the upcoming launch of the global Phase 3 clinical trial for PrimeC in ALS, planned for the second half of 2025. Ben-Noon emphasized that advancing this pivotal study is a major step forward in providing robust clinical data for the therapy and its potential impact on patients.
The letter also provided an update on progress with the Canadian regulatory pathway, where discussions with Health Canada are exploring accelerated access through a Notice of Compliance with Conditions (NOC/c). Additionally, Ben-Noon expressed optimism about ongoing strategic partnership discussions with a global pharmaceutical company, noting that although finalizing this multi-regional deal has taken more time than expected, it could transform the company operationally and financially. He thanked shareholders for their continued support as NeuroSense moves forward in its mission.
Read Announcement- Drug:
- PrimeC
- Announced Date:
- April 9, 2025
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics, Ltd. announced promising new findings from its Phase 2b PARADIGM clinical trial.
AI Summary
NeuroSense Therapeutics, Ltd. announced promising findings from its Phase 2b PARADIGM clinical trial for its ALS treatment, PrimeC. The study showed that PrimeC consistently downregulated 161 mature microRNAs (miRNAs) in treated patients, including key miRNAs like miR-199 and miR-181 that are linked to disease progression and neuroinflammation in ALS. These results suggest that PrimeC could help slow the progression of ALS by targeting molecular pathways that drive inflammation and motor neuron degeneration. The modulation of these miRNAs reinforces the potential of PrimeC as a transformative, multi-targeted therapy for ALS. The data builds on earlier clinical observations, supporting PrimeC’s ability to improve survival rates and reduce disease progression, and provides a strong foundation for further studies to explore its impact on miRNA maturation and additional neurodegenerative diseases.
Read Announcement- Drug:
- PrimeC
- Announced Date:
- April 7, 2025
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics Ltd. provides a business update.
AI Summary
NeuroSense Therapeutics Ltd. provided a business update highlighting major progress with its lead candidate, PrimeC, for treating amyotrophic lateral sclerosis (ALS). The company announced that its Phase 2b study met both primary and secondary endpoints, showing a 33% slower disease progression over 18 months and a 58% improvement in survival rates, while also preserving key functions like speaking and swallowing. PrimeC demonstrated a favorable safety and tolerability profile, which supports its potential to modify the course of ALS. Following a Type C meeting with the FDA, NeuroSense received positive feedback on the Phase 3 study design, now slated to begin in 2025. The company is in ongoing partnership discussions to advance PrimeC towards regulatory approval and eventual commercialization, including plans to file for early commercialization in Canada.
Read Announcement- Drug:
- PrimeC
- Announced Date:
- April 4, 2025
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics, Ltd. announced that two members of its Scientific Advisory Board will present new data from the Company's Phase 2b trial during the General Neurology and Late Breaker sessions at the 77th Annual American Academy of Neurology (AAN) Meeting.
AI Summary
NeuroSense Therapeutics, Ltd. announced that two members of its Scientific Advisory Board will present new data from the company’s Phase 2b trial at the 77th Annual American Academy of Neurology (AAN) Meeting. The presentations will take place during the General Neurology and Late Breaker sessions in San Diego, CA, on April 8, 2025.
Dr. Jeremy Shefner will share clinical data demonstrating PrimeC’s safety, tolerability, and efficacy as an oral candidate for ALS, highlighting its potential to reduce ALS progression while engaging multiple biomarker endpoints. Meanwhile, Dr. Jeffrey Rosenfeld will present insights on microRNA modulation and iron-related markers in ALS treatment, shedding light on the mechanism behind PrimeC’s effects. These presentations underscore the company’s focus on advancing a disease-modifying therapy for ALS.
Read Announcement- Drug:
- PrimeC
- Announced Date:
- March 20, 2025
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics Ltd. announced significant progress toward the early commercialization of PrimeC in Canada.
AI Summary
NeuroSense Therapeutics Ltd. announced significant progress toward the early commercialization of its lead ALS therapy, PrimeC, in Canada. Health Canada has invited the company to a pre-New Drug Submission meeting to discuss a potential regulatory pathway for PrimeC. The company is targeting approval by the first half of 2026, which could pave the way for earlier market entry. PrimeC is an innovative, extended-release oral formulation that combines ciprofloxacin and celecoxib. It has shown strong clinical efficacy in trials, including reductions in disease progression and improvements in survival rates. NeuroSense estimates that PrimeC could generate peak annual revenues of $100 to $150 million in the Canadian market alone. This Canadian regulatory development is a critical step in the company’s overall strategy to bring a breakthrough treatment for Amyotrophic Lateral Sclerosis to patients in need.
Read Announcement- Drug:
- PrimeC
- Announced Date:
- December 4, 2024
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics announce today statistically significant positive results from the 18-month data analysis of the PARADIGM study, evaluating the efficacy of PrimeC in the treatment of Amyotrophic Lateral Sclerosis (ALS).
AI Summary
NeuroSense Therapeutics announced statistically significant positive results from the 18‐month analysis of its PARADIGM study evaluating PrimeC in ALS treatment. Patients who received PrimeC from the beginning experienced a 33% slower progression of the disease, as shown by nearly an 8-point improvement on the ALS Functional Rating Scale-Revised compared to those who started on placebo before switching to PrimeC. Additionally, continuous treatment with PrimeC led to a striking 58% improvement in survival rates. These results, with a p-value of 0.007, underscore the potential of PrimeC to redefine the standard of care for ALS by offering a more effective approach to slowing disease progression and extending patient survival.
Read Announcement - Drug:
- PrimeC
- Announced Date:
- July 1, 2024
- Indication:
- Amyotrophic lateral sclerosis
Announcement
NeuroSense Therapeutics Ltd. reported statistically significant results from the 12-month data analysis of the PARADIGM Phase 2b study evaluating PrimeC in people living with Amyotrophic Lateral Sclerosis (ALS).
AI Summary
NeuroSense Therapeutics Ltd. reported promising results from the 12-month analysis of its PARADIGM Phase 2b study evaluating PrimeC in people with ALS. The data showed that disease progression was slowed by 36% in participants who received PrimeC from the start, compared to those initially given a placebo. The intent-to-treat analysis revealed a statistically significant difference of 6.5 points on the ALS Functional Rating Scale-Revised, with a p-value of 0.009. In addition, participants treated with PrimeC showed a 43% improvement in survival rates. A pre-defined analysis of the per-protocol population further demonstrated a difference of approximately 7.7 points, translating into more than 40% improvement. These significant findings highlight PrimeC’s potential to slow ALS progression and provide a strong rationale for advancing into a Phase 3 clinical trial in the US and Europe.
Read Announcement
NeuroSense Therapeutics FDA Events - Frequently Asked Questions
As of now, NeuroSense Therapeutics (NRSN) has not received any FDA approvals for its therapy in the last two years.
In the past two years, NeuroSense Therapeutics (NRSN) has reported FDA regulatory activity for PrimeC.
The most recent FDA-related event for NeuroSense Therapeutics occurred on March 9, 2026, involving PrimeC. The update was categorized as "Survival data," with the company reporting: "NeuroSense Therapeutics announced that the recently reported long-term survival data from its Phase 2b PARADIGM trial of PrimeC in amyotrophic lateral sclerosis (ALS) will be presented at a leading scientific conference on March 9, 2026."
Currently, NeuroSense Therapeutics has one therapy (PrimeC) targeting the following condition: Amyotrophic lateral sclerosis.
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:NRSN last updated on 3/9/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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