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BGM0504 Administered SC
BGM0504 Administered SC is a Small molecule drug developed by BrightGene Bio-Medical Technology Co., Ltd.. It is currently in Phase 2 development.
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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 | BGM0504 Administered SC |
|---|---|
| Sponsor | BrightGene Bio-Medical Technology Co., Ltd. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study of BGM0504 in Participants With Type 2 Diabetes in Indonesia (PHASE3)
- A Study of BGM0504 in Participants With Obesity (PHASE2)
- Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM0504 Injection in Non-diabetic Overweight or Obese Adult Subjects (PHASE1)
- A Study of BGM0504 in Overweight or Obese Participants (PHASE1)
- A Study of BGM0504 in Chinese Patients With Type 2 Diabetes (PHASE2)
- A Study of BGM0504 Evaluating Weight Loss in Overweight or Obese Chinese Subjects (PHASE2)
- A Study of BGM0504 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise (PHASE3)
- A Study of BGM0504 in Participants with Type 2 Diabetes (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:
- BGM0504 Administered SC CI brief — competitive landscape report
- BGM0504 Administered SC updates RSS · CI watch RSS
- BrightGene Bio-Medical Technology Co., Ltd. portfolio CI
Frequently asked questions about BGM0504 Administered SC
What is BGM0504 Administered SC?
Who makes BGM0504 Administered SC?
What development phase is BGM0504 Administered SC in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing