Last reviewed · How we verify
Mycobacterium obuense
Mycobacterium obuense is a Biologic drug developed by Immodulon Therapeutics Ltd. It is currently in Phase 2 development. Also known as: IMM-101.
-
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 | Mycobacterium obuense |
|---|---|
| Also known as | IMM-101 |
| Sponsor | Immodulon Therapeutics Ltd |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Atezolizumab in Patients With MSI-h/MMR-D Stage II High Risk and Stage III Colorectal Cancer Ineligible for Oxaliplatin (PHASE2)
- Study of IMM 101 in Combination With Standard of Care in Patients With Metastatic or Unresectable Cancer (PHASE1, PHASE2)
- A Study of IMM-101 in Combination With Radiation Induced Tumour Necrosis in Colorectal Cancer (PHASE2)
- A Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer (PHASE2)
- A Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients (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:
- Mycobacterium obuense CI brief — competitive landscape report
- Mycobacterium obuense updates RSS · CI watch RSS
- Immodulon Therapeutics Ltd portfolio CI
Frequently asked questions about Mycobacterium obuense
What is Mycobacterium obuense?
Who makes Mycobacterium obuense?
Is Mycobacterium obuense also known as anything else?
What development phase is Mycobacterium obuense in?
Related
- Manufacturer: Immodulon Therapeutics Ltd — full pipeline
- Also known as: IMM-101
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing