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SPI-1005 High dose
SPI-1005 High dose is a Small molecule drug developed by Sound Pharmaceuticals, Incorporated. It is currently in Phase 2 development. Also known as: 600mgEbselen, 600 mg Ebselen.
SPI-1005 is a small molecule being studied in clinical trials for various conditions, including Noise Induced Hearing Loss, Meniere's Disease, Temporary Auditory Threshold Shift, Lung Cancer, and Head and Neck Cancer. It is being tested in doses of 200mg and 400mg, as well as a placebo, in a Phase 2b study to evaluate its safety and efficacy.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | SPI-1005 High dose |
|---|---|
| Also known as | 600mgEbselen, 600 mg Ebselen |
| Sponsor | Sound Pharmaceuticals, Incorporated |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity (PHASE2)
- SPI-1005 for the Treatment of Patients With Meniere's Disease (PHASE2)
- Study to Evaluate SPI-1005 in Adults With Meniere's Disease (PHASE1, PHASE2)
- A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss (PHASE2)
- SPI-1005 for Prevention and Treatment of Chemotherapy Induced Hearing Loss (PHASE2)
- Otoprotection With SPI-1005 for Prevention of Temporary Auditory Threshold Shift (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:
- SPI-1005 High dose CI brief — competitive landscape report
- SPI-1005 High dose updates RSS · CI watch RSS
- Sound Pharmaceuticals, Incorporated portfolio CI
Frequently asked questions about SPI-1005 High dose
What is SPI-1005 High dose?
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Related
- Manufacturer: Sound Pharmaceuticals, Incorporated — full pipeline
- Also known as: 600mgEbselen, 600 mg Ebselen
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing