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Part 1: Spray 1
Part 1: Spray 1 is a Small molecule drug developed by Food and Drug Administration (FDA). It is currently in Phase 1 development. Also known as: Avobenzone, Homosalate, Octisalate, Octocrylene.
Etripamil is being studied for its efficacy and safety in terminating spontaneous Paroxysmal Supraventricular Tachycardia (PSVT). Clinical trials also involve studying etripamil for other conditions, including Colon Polyps, Colorectal Cancer, Inflammatory Bowel Disease (IBD), and Food Allergy.
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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 | Part 1: Spray 1 |
|---|---|
| Also known as | Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone |
| Sponsor | Food and Drug Administration (FDA) |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Clinical Trial of Intranasal Delivery of NT-301 (PHASE1)
- Safety and Efficacy of Human Adipose-Derived Stem Cell Exosomes in Acute Ischemic Stroke (PHASE1, PHASE2)
- Impact of a Sensory Rehabilitation Program on Olfactory-gustatory Alterations in Patients Treated With Chemotherapy for Haematological Cancer (NA)
- A Phase I Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VVN432 Nasal Spray (PHASE1)
- PK/PD Study of IN-001 Sublingual Spray in Healthy Adults (PHASE1)
- A Study to Determine the Optimal Dose and Frequency of ALDP001 Nasal Spray in Adults With Seasonal Allergic Rhinitis Under Allergen Exposure (PHASE2)
- Phase 1 Study on Bioavailability, Food Effect, and Drug-Drug Interaction of ALG-097558 Tablets in Healthy Volunteers (PHASE1)
- The NODE-202 Study (Study of Etripamil Nasal Spray in Pediatric Patients) (PHASE2)
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:
- Part 1: Spray 1 CI brief — competitive landscape report
- Part 1: Spray 1 updates RSS · CI watch RSS
- Food and Drug Administration (FDA) portfolio CI
Frequently asked questions about Part 1: Spray 1
What is Part 1: Spray 1?
Who makes Part 1: Spray 1?
Is Part 1: Spray 1 also known as anything else?
What development phase is Part 1: Spray 1 in?
Related
- Manufacturer: Food and Drug Administration (FDA) — full pipeline
- Also known as: Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing