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SPC4001
SPC4001 is a Small molecule drug developed by Shin Poong Pharmaceutical Co. Ltd.. It is currently in Phase 2 development. Also known as: Amlodipine 5mg.
SPC4001 is not mentioned in the provided facts, but SPC1001 is being studied for the treatment of Essential Hypertension. The study involves comparing the efficacy and safety of SPC1001 with monotherapy in patients with Essential Hypertension.
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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 | SPC4001 |
|---|---|
| Also known as | Amlodipine 5mg |
| Sponsor | Shin Poong Pharmaceutical Co. Ltd. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Evaluate the Efficacy and Safety of SPC1001 and Monotherapy in Patients With Essential Hypertension (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:
- SPC4001 CI brief — competitive landscape report
- SPC4001 updates RSS · CI watch RSS
- Shin Poong Pharmaceutical Co. Ltd. portfolio CI
Frequently asked questions about SPC4001
What is SPC4001?
Who makes SPC4001?
Is SPC4001 also known as anything else?
What development phase is SPC4001 in?
Related
- Manufacturer: Shin Poong Pharmaceutical Co. Ltd. — full pipeline
- Also known as: Amlodipine 5mg
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing