Last reviewed · How we verify
Combination therapy (COMB)
Combination therapy (COMB) is a Small molecule drug developed by Ann & Robert H Lurie Children's Hospital of Chicago. It is currently in Phase 3 development. Also known as: SSRI plus CBT, COMB, Trifluridine/tipiracil, Anlotinib.
A combination therapy approach that uses multiple agents together to enhance therapeutic efficacy, though the specific components and their mechanisms are not publicly detailed.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Combination therapy (COMB) |
|---|---|
| Also known as | SSRI plus CBT, COMB, Trifluridine/tipiracil, Anlotinib |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Combination therapies typically work by targeting multiple pathways or mechanisms simultaneously to improve treatment outcomes beyond what single agents can achieve. The exact composition and mechanism of this particular combination therapy from Lurie Children's Hospital is not specified in available public information, limiting detailed mechanistic characterization.
Approved indications
Common side effects
Key clinical trials
- Ivonescimab in Comb. With FOLFOX in Advanced HER2 Neg. GEA (PHASE2)
- Improving the Treatment of Depression Among Youth With HIV (NA)
- A Phase 1 Study Of FLAG Chemotherapy In Combination With Lisaftoclax And Pelcitoclax In Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (PHASE1)
- Safe Treatment for Emergency Presentation for Suicidal Ideation and Behavior in Youth (PHASE2)
- High-Intensity Exercise and High-Fiber Diet for Immunotherapy Outcomes in Melanoma Patients: The DUO Trial (NA)
- A Study of Trifluridine/Tipiracil Combined With Anlotinib as Second-line Treatment for Recurrent and Metastatic Esophageal Squamous Cell Carcinoma (PHASE2)
- Evaluating Combined Electromagnetic Stimulation for Enhanced Physical and Psychological Recovery in Athletes with DOMS (NA)
- Partners in Caring for Anxious Youth (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:
- Combination therapy (COMB) CI brief — competitive landscape report
- Combination therapy (COMB) updates RSS · CI watch RSS
- Ann & Robert H Lurie Children's Hospital of Chicago portfolio CI
Frequently asked questions about Combination therapy (COMB)
What is Combination therapy (COMB)?
How does Combination therapy (COMB) work?
Who makes Combination therapy (COMB)?
Is Combination therapy (COMB) also known as anything else?
What development phase is Combination therapy (COMB) in?
Related
- Manufacturer: Ann & Robert H Lurie Children's Hospital of Chicago — full pipeline
- Also known as: SSRI plus CBT, COMB, Trifluridine/tipiracil, Anlotinib
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing