Last reviewed · How we verify
SER120 1500 ng
SER120 1500 ng is a Small molecule drug developed by Serenity Pharmaceuticals, Inc.. It is currently in Phase 3 development.
SER120 is an investigational therapeutic agent in Phase 3 development by Serenity Pharmaceuticals with an undisclosed mechanism of action.
SER120 is a small molecule being investigated for the treatment of nocturia. It is being studied in a randomized, double-blind, placebo-controlled trial in various doses, including 750 ng/day, 1000 ng/day, and 1500 ng/day.
-
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 | SER120 1500 ng |
|---|---|
| Sponsor | Serenity Pharmaceuticals, Inc. |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Without publicly available information on SER120's molecular target or mechanism, the specific biological pathway and therapeutic rationale cannot be determined. The drug designation '1500 ng' likely refers to a dosing or formulation parameter rather than a mechanistic descriptor.
Approved indications
Common side effects
Key clinical trials
- Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia - DB4 (PHASE3)
- Multicenter Study to Investigate SER120 Nasal Spray Formulations in Patients With Nocturia (PHASE2, 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:
- SER120 1500 ng CI brief — competitive landscape report
- SER120 1500 ng updates RSS · CI watch RSS
- Serenity Pharmaceuticals, Inc. portfolio CI
Frequently asked questions about SER120 1500 ng
What is SER120 1500 ng?
How does SER120 1500 ng work?
Who makes SER120 1500 ng?
What development phase is SER120 1500 ng in?
Related
- Manufacturer: Serenity Pharmaceuticals, Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing