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CM4620-IE
CM4620-IE is a calcium channel blocker Small molecule drug developed by CalciMedica, Inc.. It is currently in Phase 2 development for Atrial fibrillation for stroke prevention.
CM4620-IE is a small molecule that targets the calcium channel.
CM4620-IE is a small molecule that targets the calcium channel. Used for Atrial fibrillation for stroke prevention.
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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). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| 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 | CM4620-IE |
|---|---|
| Sponsor | CalciMedica, Inc. |
| Drug class | calcium channel blocker |
| Target | L-type calcium channel |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 2 |
Mechanism of action
It works by inhibiting the L-type calcium channel, which is involved in the regulation of cardiac muscle contraction. This leads to a reduction in cardiac workload and oxygen demand, making it a potential treatment for conditions such as atrial fibrillation.
Approved indications
- Atrial fibrillation for stroke prevention
Common side effects
- Hypotension
- Dizziness
- Headache
Key clinical trials
- A Study of Auxora in Patients With Critical COVID-19 Pneumonia (PHASE2)
- Study of CM4620 to Reduce the Severity of Pancreatitis Due to Asparaginase (PHASE1, PHASE2)
- A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS (PHASE2)
- A Study of Auxora in Patients With Severe COVID-19 Pneumonia (PHASE2)
- A PK/PD Study of CM4620-IE in Patients With Acute Pancreatitis (PHASE2)
- CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS (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:
- CM4620-IE CI brief — competitive landscape report
- CM4620-IE updates RSS · CI watch RSS
- CalciMedica, Inc. portfolio CI
Frequently asked questions about CM4620-IE
What is CM4620-IE?
How does CM4620-IE work?
What is CM4620-IE used for?
Who makes CM4620-IE?
What drug class is CM4620-IE in?
What development phase is CM4620-IE in?
What are the side effects of CM4620-IE?
What does CM4620-IE target?
Related
- Drug class: All calcium channel blocker drugs
- Target: All drugs targeting L-type calcium channel
- Manufacturer: CalciMedica, Inc. — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Atrial fibrillation for stroke prevention
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing