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Regimen 1, Course 2
Regimen 1, Course 2 is a Small molecule drug developed by Baylor College of Medicine. It is currently in Phase 1 development.
Regimen 1, Course 2 is not specified in the provided facts. However, based on the information, Regimen 1, Course 2 is associated with the treatment of Chronic Hepatitis C, Glioma, Glioblastoma, Acute Myeloid Leukemia, Adult, and Cervical Squamous Cell Carcinoma In Situ.
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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 | Regimen 1, Course 2 |
|---|---|
| Sponsor | Baylor College of Medicine |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia (NA)
- Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer (PHASE3)
- Standard-dose vs Intermediate-dose Cytarabine Induction in the Treatment of Acute Myeloid Leukemia With RUNX1-RUNX1T1 (PHASE3)
- Safety and Efficacy of OBX-115 in Advanced Solid Tumors (PHASE1, PHASE2)
- Alternate Day Fasting After Surgery for Patients Undergoing Chemotherapy (NA)
- Full-Course Immunotherapy Consolidation for Unfit or Fit B-ALL Who Decline Chemotherapy (PHASE2)
- Intestinal Microbiota Transplantation in Patients With Chronic Heart Failure (PHASE1)
- Cyclophosphamide, Paclitaxel, and Trastuzumab in Treating Stage I-II HER2/Neu Positive Breast Cancer After Surgery (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:
- Regimen 1, Course 2 CI brief — competitive landscape report
- Regimen 1, Course 2 updates RSS · CI watch RSS
- Baylor College of Medicine portfolio CI
Frequently asked questions about Regimen 1, Course 2
What is Regimen 1, Course 2?
Who makes Regimen 1, Course 2?
What development phase is Regimen 1, Course 2 in?
Related
- Manufacturer: Baylor College of Medicine — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing