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Prototype capsule GDC-0134
Prototype capsule GDC-0134 is a Small molecule drug developed by Genentech, Inc.. It is currently in Phase 1 development.
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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 | Prototype capsule GDC-0134 |
|---|---|
| Sponsor | Genentech, Inc. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- Headache
- Haemoglobin decreased
- Dizziness
- Paraesthesia
- Presyncope
- Somnolence
- Diarrhoea
- Nausea
- Vomiting
- Haematocrit decreased
- Mean cell volume decreased
- Arthralgia
Key clinical trials
- Bioavailability of GDC-0134 and the Effect of Food and Proton Pump Inhibitor on Pharmacokinetics of GDC-0134 in Healthy Female Participants (PHASE1)
- A Study to Determine the Bioavailability of Various Formulations of GDC-0134 in Healthy Female Participants of Non-Childbearing Potential (PHASE1)
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:
- Prototype capsule GDC-0134 CI brief — competitive landscape report
- Prototype capsule GDC-0134 updates RSS · CI watch RSS
- Genentech, Inc. portfolio CI
Frequently asked questions about Prototype capsule GDC-0134
What is Prototype capsule GDC-0134?
Who makes Prototype capsule GDC-0134?
What development phase is Prototype capsule GDC-0134 in?
What are the side effects of Prototype capsule GDC-0134?
Related
- Manufacturer: Genentech, Inc. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing