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Procedure/Standard care
Procedure/Standard care is a Small molecule drug developed by Centre Hospitalier Universitaire, Amiens. It is currently in Phase 3 development.
Standard care represents the established clinical management protocol for a given condition, serving as the control or baseline treatment against which investigational interventions are compared.
Standard care is the primary intervention used in various clinical trials, including those for myocardial infarction, reperfusion injury, and different types of neoplasms. Standard care is also compared to other interventions such as transcoronary cooling and dilution in clinical trials, including NCT06128993, which focuses on cardioprotection during revascularization for ST-elevation myocardial infarction.
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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 | Procedure/Standard care |
|---|---|
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
Standard care encompasses the current best-practice medical interventions, surgical procedures, and supportive therapies that are routinely administered to patients with a specific disease or condition. In clinical trials, standard care serves as the comparator arm to evaluate whether new treatments provide additional benefit. The specific mechanisms depend entirely on the condition being treated and the established protocols at the treating institution.
Approved indications
Common side effects
Key clinical trials
- Parent Study Name: Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB Pure) (NA)
- A Study of Weight Loss Intervention With Tirzepatide and Progestin Intrauterine Device to Treat Endometrial Hyperplasia and Grade 1 Endometrial Cancer (PHASE2)
- Shared Decision-Making Decision Aid for Newly Diagnosed Breast Cancer : A Multi-Center Randomized Controlled Trial (NA)
- A Self-management Program to Prevent Falls in People With Multiple Sclerosis (NA)
- Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial (PHASE3)
- A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome (PHASE3)
- Nutritional Effects in Cardiovascular Surgery (NA)
- Individualised Endometrial Cancer Risk Stratification by Bayesian Prediction Model (ENDORISK), Optimizing Clinical Implementation (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:
- Procedure/Standard care CI brief — competitive landscape report
- Procedure/Standard care updates RSS · CI watch RSS
- Centre Hospitalier Universitaire, Amiens portfolio CI
Frequently asked questions about Procedure/Standard care
What is Procedure/Standard care?
How does Procedure/Standard care work?
Who makes Procedure/Standard care?
What development phase is Procedure/Standard care in?
Related
- Manufacturer: Centre Hospitalier Universitaire, Amiens — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing