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N-acetylcysteine and ascorbic acid
N-acetylcysteine and ascorbic acid is a Small molecule drug developed by University of Thessaly. It is currently in Phase 1 development.
N-acetylcysteine (NAC) and ascorbic acid (Vitamin C) have been studied in clinical trials for various conditions, including COVID-19, contrast-induced nephropathy, and pneumonia. The exact mechanisms of action for NAC and Vitamin C are not specified in the provided information, but they have been investigated as potential treatments in these conditions.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | N-acetylcysteine and ascorbic acid |
|---|---|
| Sponsor | University of Thessaly |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Effect of Metabolic Modulation on a Post-acute COVID-19 Vaccination Syndrome (PACVS) Cohort (PHASE2)
- Combination of Vitamin C and N-Acetylcysteine to Improve Functional Outcome After Rotator Cuff Repair (PHASE4)
- Safety and Efficacy of Hydroxychloroquine for the Treatment & Prevention of Coronavirus Disease 2019 (COVID-19) Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (PHASE1)
- Clinical Trial of Antioxidant Therapy in Patients With Septic Shock (PHASE3)
- Clinical Trial With N-acetylcysteine and Bromhexine for COVID-19 (PHASE3)
- Antioxidants as Adjuvant Therapy to Standard Therapy in Patients With COVID-19 (NA)
- VitamIn and oXygen Interventions and Cardiovascular Events (PHASE4)
- Retrospective Study of ImmunoFormulation for COVID-19
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- N-acetylcysteine and ascorbic acid CI brief — competitive landscape report
- N-acetylcysteine and ascorbic acid updates RSS · CI watch RSS
- University of Thessaly portfolio CI
Frequently asked questions about N-acetylcysteine and ascorbic acid
What is N-acetylcysteine and ascorbic acid?
Who makes N-acetylcysteine and ascorbic acid?
What development phase is N-acetylcysteine and ascorbic acid in?
Related
- Manufacturer: University of Thessaly — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing