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S8 Sinus Implant
S8 Sinus Implant is a Corticosteroid Small molecule drug developed by Intersect ENT. It is currently in Phase 3 development for Treatment of chronic sinusitis, Treatment of nasal polyps. Also known as: SINUVA (mometasone furoate) sinus implant.
S8 Sinus Implant is a drug that delivers corticosteroids directly to the nasal passages to reduce inflammation and swelling.
The S8 Sinus Implant is a small molecule implant used to treat conditions such as chronic sinusitis, nasal polyps, and nasal polyposis. It is designed to be used in post-sinus surgery patients with recurrent sinus obstruction.
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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 | S8 Sinus Implant |
|---|---|
| Also known as | SINUVA (mometasone furoate) sinus implant |
| Sponsor | Intersect ENT |
| Drug class | Corticosteroid |
| Modality | Small molecule |
| Therapeutic area | Otolaryngology |
| Phase | Phase 3 |
Mechanism of action
The implant is designed to provide sustained release of the corticosteroid, which helps to reduce inflammation and swelling in the nasal passages. This can provide relief for patients with chronic sinusitis or other nasal conditions.
Approved indications
- Treatment of chronic sinusitis
- Treatment of nasal polyps
Common side effects
- Nasal discomfort
- Nasal bleeding
- Headache
Key clinical trials
- Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE) (PHASE3)
- S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps (PHASE3)
- Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps (PHASE2, PHASE3)
- Safety and Performance of the Steroid-Releasing S8 Sinus Implant (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:
- S8 Sinus Implant CI brief — competitive landscape report
- S8 Sinus Implant updates RSS · CI watch RSS
- Intersect ENT portfolio CI
Frequently asked questions about S8 Sinus Implant
What is S8 Sinus Implant?
How does S8 Sinus Implant work?
What is S8 Sinus Implant used for?
Who makes S8 Sinus Implant?
Is S8 Sinus Implant also known as anything else?
What drug class is S8 Sinus Implant in?
What development phase is S8 Sinus Implant in?
What are the side effects of S8 Sinus Implant?
Related
- Drug class: All Corticosteroid drugs
- Manufacturer: Intersect ENT — full pipeline
- Therapeutic area: All drugs in Otolaryngology
- Indication: Drugs for Treatment of chronic sinusitis
- Indication: Drugs for Treatment of nasal polyps
- Also known as: SINUVA (mometasone furoate) sinus implant
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing