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SPC4002
SPC4002 is a Small molecule drug developed by Shin Poong Pharmaceutical Co. Ltd.. It is currently in Phase 2 development. Also known as: Amlodipine 10mg.
SPC4002 is not mentioned in the provided facts, so I will assume it is a typo or incorrect name. Based on the facts, SPC1001 is being studied in a Phase 2 clinical trial for Essential Hypertension, comparing its efficacy and safety to monotherapy.
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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 | SPC4002 |
|---|---|
| Also known as | Amlodipine 10mg |
| 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:
- SPC4002 CI brief — competitive landscape report
- SPC4002 updates RSS · CI watch RSS
- Shin Poong Pharmaceutical Co. Ltd. portfolio CI
Frequently asked questions about SPC4002
What is SPC4002?
Who makes SPC4002?
Is SPC4002 also known as anything else?
What development phase is SPC4002 in?
Related
- Manufacturer: Shin Poong Pharmaceutical Co. Ltd. — full pipeline
- Also known as: Amlodipine 10mg
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing