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Hercules
Hercules is a Biologic drug developed by Mylan Pharmaceuticals Inc. It is currently in Phase 1 development. Also known as: Trastuzumab.
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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 | Hercules |
|---|---|
| Also known as | Trastuzumab |
| Sponsor | Mylan Pharmaceuticals Inc |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck (NA)
- A Study of Trastuzumab Deruxtecan in People With Non-Small Cell Lung Cancer (PHASE2)
- Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (HERCULES) (PHASE3)
- The Effect of a Higher Dose of Dehydroepiandrosterone (DHEA) Supplementation in Poor Responders (NA)
- Hepatitis C Positive Organ to Recipient Hepatitis C Negative Longitudinal Transplant Study
- Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES) (PHASE3)
- Study of Efficacy and Safety of Myl1401O + Taxane vs Herceptin©+ Taxane for 1st Line, Met. Br. Ca. (PHASE3)
- Prevalence of HPV-associated Eye Infection and Cytokine Levels in Tears From Patients Diagnosed With Pterygium
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:
- Hercules CI brief — competitive landscape report
- Hercules updates RSS · CI watch RSS
- Mylan Pharmaceuticals Inc portfolio CI
Frequently asked questions about Hercules
What is Hercules?
Who makes Hercules?
Is Hercules also known as anything else?
What development phase is Hercules in?
Related
- Manufacturer: Mylan Pharmaceuticals Inc — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Trastuzumab
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing