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99mTc sulfur colloid
99mTc sulfur colloid is a Small molecule drug developed by Otsuka Pharmaceutical Co., Ltd.. It is currently in Phase 2 development. Also known as: Technetium Tc 99m Sulfur Colloid Injection.
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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 | 99mTc sulfur colloid |
|---|---|
| Also known as | Technetium Tc 99m Sulfur Colloid Injection |
| Sponsor | Otsuka Pharmaceutical Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
- Esophagitis Grade 2
- Pneumonitis Grade 2
- Fatigue Grade 2
- Dermatitis Grade 2
- Nausea
- Vomiting
- Intermittent headaches
Key clinical trials
- Sulfur Colloid SPECT/CT in Measuring Liver Function in Patients With Primary or Metastatic Liver Cancer Undergoing Radiation Therapy or Surgery (NA)
- Personalized Neck Radiation Therapy Directed by Sentinel Lymph Node Biopsy for the Treatment of Oral Cavity Squamous Cell Carcinoma, PRECEDENT Trial (PHASE2)
- FLARE RT for Patients With Stage IIB-IIIB Non-small Cell Lung Cancer: Personalizing Radiation Therapy Using PET/CT and SPECT/CT Imaging (PHASE2)
- Monoclonal Antibody Therapy in Treating Patients Scheduled for Surgery to Remove Ovarian Cancer (PHASE1)
- Comparison of Use of Indocyanine Green and 99mTc-labeled Radiotracer for Axillary Lymphatic Mapping in Patients With Breast Cancer (NA)
- Study of Oro-cecal Transit Time in Healthy Subjects Using Scintigraphy and Lactulose Hydrogen Breath Test.
- Sentinel Lymph Node Biopsy Findings in Patients With Breast Cancer (PHASE4)
- Phase 2 Study to Evaluate the Preliminary Performance of the C13-URA Breath Test Kit in Dyspeptic Subjects (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:
- 99mTc sulfur colloid CI brief — competitive landscape report
- 99mTc sulfur colloid updates RSS · CI watch RSS
- Otsuka Pharmaceutical Co., Ltd. portfolio CI
Frequently asked questions about 99mTc sulfur colloid
What is 99mTc sulfur colloid?
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Is 99mTc sulfur colloid also known as anything else?
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Related
- Manufacturer: Otsuka Pharmaceutical Co., Ltd. — full pipeline
- Also known as: Technetium Tc 99m Sulfur Colloid Injection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing