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Radioiodine
Radioiodine is a Small molecule drug developed by Institut de Radioprotection et de Surete Nucleaire. It is currently in Phase 2 development. Also known as: 131 I.
Radioiodine is used to treat conditions such as differentiated thyroid cancer, thyroid neoplasms, thyroid cancer, and thyroid carcinoma. It is administered in various forms, including rhTSH and donafenib, which are being studied in clinical trials for their efficacy and safety in these conditions.
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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 | Radioiodine |
|---|---|
| Also known as | 131 I |
| Sponsor | Institut de Radioprotection et de Surete Nucleaire |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Trametinib in Increasing Tumoral Iodine Incorporation in Patients With Recurrent or Metastatic Thyroid Cancer (PHASE2)
- ImmunoPET Targeting Trophoblast Cell-Surface Antigen 2 (Trop-2) in Thyroid Cancer (NA)
- A Study of Avutometinib and Defactinib in People With Thyroid Cancer (PHASE2)
- Testing the Combination of Cabozantinib, Nivolumab, and Ipilimumab (CaboNivoIpi) for Advanced Differentiated Thyroid Cancer (PHASE2)
- Studies on Tumors of the Thyroid
- Lesion Dosimetry With Iodine-124 in Metastatic Thyroid Carcinoma (PHASE1)
- A Study to Evaluate the Safety and Efficacy of Lenvatinib in Participants With Refractory Differentiated Thyroid Cancer (PHASE4)
- Adjuvant Radiotherapy in High Risk Locally Advanced DTC (PHASE3)
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:
- Radioiodine CI brief — competitive landscape report
- Radioiodine updates RSS · CI watch RSS
- Institut de Radioprotection et de Surete Nucleaire portfolio CI
Frequently asked questions about Radioiodine
What is Radioiodine?
Who makes Radioiodine?
Is Radioiodine also known as anything else?
What development phase is Radioiodine in?
Related
- Manufacturer: Institut de Radioprotection et de Surete Nucleaire — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: 131 I
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing