Last reviewed · How we verify
131I-TM-601
131I-TM-601 is a Radiopharmaceutical Small molecule drug developed by TransMolecular. It is currently in Phase 1 development.
A radioiodinated synthetic peptide that binds to tumor cells for targeted delivery of radiation therapy.
131I-TM-601 is a treatment being studied for glioma, brain neoplasm, malignant glioma, glioblastoma multiforme, and GBM. It is administered intracavitary in a Phase I/II study to assess its safety and tolerability in adult patients with recurrent high-grade glioma.
-
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 | 131I-TM-601 |
|---|---|
| Sponsor | TransMolecular |
| Drug class | Radiopharmaceutical |
| Modality | Small molecule |
| Phase | Phase 1 |
Mechanism of action
131I-TM-601 consists of a synthetic chlorotoxin-like peptide labeled with radioactive iodine-131. The peptide component binds selectively to certain tumor cells, particularly gliomas, allowing targeted delivery of beta radiation to malignant tissue while sparing normal cells.
Approved indications
Common side effects
Key clinical trials
- Safety and Dose-Finding Study of TM-601 in Adults With Recurrent Malignant Glioma (PHASE1)
- A Study of 131I-TM601 in Adults With Recurrent Malignant Glioma (PHASE1, PHASE2)
- A Safety and Efficacy Study of Intravenous 131I-TM601 in Adult Patients With Malignant Melanoma (PHASE1, PHASE2)
- 131-I-TM-601 Study in Adults With Recurrent High-Grade Glioma (PHASE2)
- 131-I-TM-601 Study in Adults With Solid Tumors (PHASE1)
- Safety and Tolerability Study of 131I-TM-601 to Treat Adult Patients With Recurrent Glioma. (PHASE1, 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:
- 131I-TM-601 CI brief — competitive landscape report
- 131I-TM-601 updates RSS · CI watch RSS
- TransMolecular portfolio CI
Frequently asked questions about 131I-TM-601
What is 131I-TM-601?
How does 131I-TM-601 work?
Who makes 131I-TM-601?
What drug class is 131I-TM-601 in?
What development phase is 131I-TM-601 in?
Related
- Drug class: All Radiopharmaceutical drugs
- Manufacturer: TransMolecular — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing