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Spermine
Spermine is a Biologic drug developed by dr. Riana Pauline Tamba, SpB(K)BA. It is currently in Phase 1 development.
Spermine is a polyamine involved in cellular metabolism found in all eukaryotic cells, synthesized from the amino acid ornithine. It is a small molecule that functions as a polycation at physiological pH, associated with nucleic acids and thought to stabilize helical structure.
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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 | Spermine |
|---|---|
| Sponsor | dr. Riana Pauline Tamba, SpB(K)BA |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Move Your Spondyl " Better Live Its Rheumatism With the Physical Activity " (NA)
- Asthma and Technology in Emerging African American Adults (NA)
- CBF and NCF Changes With Brain Radiation
- Effectiveness of Transdiagnostic Cognitive Behavioral Therapy for Improving HIV Treatment Outcomes in South Africa (NA)
- Investigation of Small Mobile Stem Cells (SMS Cells) in Participants With Chronic Obstructive Pulmonary Disease (COPD). (PHASE1)
- Stereotactic Radiotherapy in Oligometastatic Brain Disease: a Randomised Phase III Study Comparing Hypofractionated Stereotactic Radiation Therapy (3*10 Gy) to the Historical Single-dose Radiosurgery (1*20 to 25 Gy) With Medico-economic Evaluation. (NA)
- Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy (NA)
- The Effects of Tiopronin on 3-Aminopropanal Level & Neurologic Outcome After Aneurysmal Subarachnoid Hemorrhage (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:
- Spermine CI brief — competitive landscape report
- Spermine updates RSS · CI watch RSS
- dr. Riana Pauline Tamba, SpB(K)BA portfolio CI
Frequently asked questions about Spermine
What is Spermine?
Who makes Spermine?
What development phase is Spermine in?
Related
- Manufacturer: dr. Riana Pauline Tamba, SpB(K)BA — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing