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DM-CHOC-PEN
DM-CHOC-PEN is a Alkylating-like agent Small molecule drug developed by DEKK-TEC, Inc.. It is currently in Phase 2 development. Also known as: 4-Demethylcholesteryloxycarbonylpenclomedine.
DM-CHOC-PEN is a polychlorinated pyridine cholesteryl carbonate designed to cross the blood-brain barrier and deliver anticancer activity to brain tumors.
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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 | DM-CHOC-PEN |
|---|---|
| Also known as | 4-Demethylcholesteryloxycarbonylpenclomedine |
| Sponsor | DEKK-TEC, Inc. |
| Drug class | Alkylating-like agent |
| Modality | Small molecule |
| Phase | Phase 2 |
Mechanism of action
DM-CHOC-PEN is designed as a lipophilic alkylating-like agent that can penetrate the blood-brain barrier due to its cholesterol-based structure. Once inside tumor cells, it is believed to interfere with DNA synthesis and cell division, leading to cancer cell death.
Approved indications
Common side effects
Key clinical trials
- DM-CHOC-PEN for Brain Tumors in AYA Subjects (PHASE2)
- DM-CHOC-PEN Plus Radiation for Brain Tumors (PHASE1)
- Study of 4-Demethyl-4-cholesteryloxycarbonylpenclome (DM-CHOC-PEN) in Patients With Brain Tumors (PHASE2)
- A Phase I Trial of DM-CHOC-PEN in Adolescent and Young Adult (AYA) Subjects With Advanced Cancers
- Study of 4-Demethylcholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) in Patients With Advanced Cancer (PHASE1)
- Study of 4-Demethylcholesteryloxycarbonylpenclomedine (DM-CHOC-PEN) in Patients With Advanced Cancer" (PHASE1)
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:
- DM-CHOC-PEN CI brief — competitive landscape report
- DM-CHOC-PEN updates RSS · CI watch RSS
- DEKK-TEC, Inc. portfolio CI
Frequently asked questions about DM-CHOC-PEN
What is DM-CHOC-PEN?
How does DM-CHOC-PEN work?
Who makes DM-CHOC-PEN?
Is DM-CHOC-PEN also known as anything else?
What drug class is DM-CHOC-PEN in?
What development phase is DM-CHOC-PEN in?
Related
- Drug class: All Alkylating-like agent drugs
- Manufacturer: DEKK-TEC, Inc. — full pipeline
- Also known as: 4-Demethylcholesteryloxycarbonylpenclomedine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing