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GSP 301 NS
GSP 301 NS is a Small molecule drug developed by Glenmark Specialty S.A.. It is currently in Phase 3 development.
GSP 301 NS is a nasal spray formulation designed to deliver its active pharmaceutical ingredient through the nasal mucosa for systemic or local therapeutic effect.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | GSP 301 NS |
|---|---|
| Sponsor | Glenmark Specialty S.A. |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
GSP 301 NS represents a nasal spray delivery system developed by Glenmark Specialty. The specific molecular mechanism and target are not publicly disclosed in readily available sources. The 'NS' designation typically indicates a nasal spray formulation, which allows for non-invasive administration and potentially improved bioavailability or patient compliance compared to oral or injectable routes.
Approved indications
Common side effects
Key clinical trials
- To Study GSP 301 in Patients With Seasonal Allergic Rhinitis (PHASE2)
- Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR) (PHASE3)
- Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR) (PHASE3)
- Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR) (PHASE3)
- Efficacy and Safety of Fixed Dose Combination (FDC) of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray (Molo; Also Referred as GSP 301) in the Treatment of Seasonal Allergic Rhinitis (SAR) (PHASE2)
- Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR) (PHASE3)
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:
- GSP 301 NS CI brief — competitive landscape report
- GSP 301 NS updates RSS · CI watch RSS
- Glenmark Specialty S.A. portfolio CI
Frequently asked questions about GSP 301 NS
What is GSP 301 NS?
How does GSP 301 NS work?
Who makes GSP 301 NS?
What development phase is GSP 301 NS in?
Related
- Manufacturer: Glenmark Specialty S.A. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing