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Components
Components is a Biologic drug developed by University of Alabama at Birmingham. It is currently in Phase 3 development.
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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 | Components |
|---|---|
| Sponsor | University of Alabama at Birmingham |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Assessment of Periprosthetic Bone Mineral Density in Patients Undergoing Total Knee Prosthesis of Different Design (NA)
- Shared Decision-Making Decision Aid for Newly Diagnosed Breast Cancer : A Multi-Center Randomized Controlled Trial (NA)
- Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer (PHASE2)
- Living With Multimorbidity: Care Coordination and Symptom Management Program (COORDINATE) (NA)
- Clinical Evaluation of an Experimental Remineralization Product (NA)
- Building Access to Food Through Systems and Solidarity (NA)
- Part B- G1X-CGD (Lentiviral Vector Transduced CD34+ Cells) in Patients With X-Linked Chronic Granulomatous Disease (PHASE1, PHASE2)
- Effectiveness of Combined Super Inductive System (SIS) Therapy With Therapeutic Exercise and Health Education in Lateral Elbow Tendinopathy (NA)
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:
- Components CI brief — competitive landscape report
- Components updates RSS · CI watch RSS
- University of Alabama at Birmingham portfolio CI
Frequently asked questions about Components
What is Components?
Who makes Components?
What development phase is Components in?
Related
- Manufacturer: University of Alabama at Birmingham — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing