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dacomitinib hydrate (dacomitinib-hydrate)
dacomitinib hydrate (generic name: dacomitinib-hydrate) is a The usual adult starting dosage for oral use is 45mg of dacomitinib hydrate once daily. The dose sho drug developed by Pfizer Inc.. It is currently in preclinical development for EGFR mutation-positive, unresectable or recurrent non-small cell lung cancer, Non-small cell lung cancer, positive for epidermal growth factor receptor expression.
The usual adult starting dosage for oral use is 45mg of dacomitinib hydrate once daily. The dose sho
Dacomitinib hydrate is an irreversible pan-HER tyrosine kinase inhibitor approved for first-line treatment of metastatic non-small cell lung cancer with EGFR mutations. It blocks multiple growth signals (EGFR, HER2, HER4) more comprehensively than reversible inhibitors, potentially overcoming resistance mechanisms and offering improved progression-free survival.
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Baseline preclinical → approval rate
+5.0pp
Industry-wide preclinical drugs reach approval ~5% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2036–2040 | — |
| EMA | EU | 2037–2041 | +0.7 yr |
| MHRA | GB | 2037–2041 | +0.7 yr |
| Health Canada | CA | 2037–2042 | +0.9 yr |
| TGA | AU | 2037–2042 | +1.2 yr |
| PMDA | JP | 2037–2042 | +1.5 yr |
| NMPA | CN | 2038–2043 | +2.3 yr |
| MFDS | KR | 2037–2042 | +1.4 yr |
| CDSCO | IN | 2037–2043 | +1.8 yr |
| ANVISA | BR | 2038–2043 | +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 | dacomitinib-hydrate |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | The usual adult starting dosage for oral use is 45mg of dacomitinib hydrate once daily. The dose sho |
| Target | Cyclin-G-associated kinase, Receptor-interacting serine/threonine-protein kinase 2, Receptor-interacting serine/threonine-protein kinase 3 |
| Therapeutic area | Oncology |
| Phase | preclinical |
Mechanism of action
Dacomitinib works by permanently disabling a family of proteins called HER receptors that sit on the surface of lung cancer cells. These receptors normally receive growth signals from the body, telling the cancer cells to multiply. By locking onto and permanently inactivating these receptors—particularly EGFR, HER2, and HER4—dacomitinib cuts off the cancer cell's ability to receive these growth commands. What makes dacomitinib different from some earlier drugs is that it targets multiple receptors in the HER family simultaneously and binds irreversibly, meaning once it attaches to a receptor, it doesn't let go. This comprehensive blocking approach makes it harder for cancer cells to develop workarounds or resistance. It's specifically effective in lung cancers that have mutations in the EGFR gene, which makes those cancer cells especially dependent on this signaling pathway for survival. The drug is given as a daily pill and works best in patients whose tumors have these specific EGFR mutations, as they rely heavily on this pathway. By shutting down multiple related growth signals at once and doing so permanently, dacomitinib can stop the cancer from growing and spreading more effectively than drugs that only block one receptor or bind reversibly.
Approved indications
- EGFR mutation-positive, unresectable or recurrent non-small cell lung cancer
- Non-small cell lung cancer, positive for epidermal growth factor receptor expression
Pipeline indications
- EGFR Mutation-positive Inoperable or Reccrent NSCLC — preclinical
Common side effects
Key clinical trials
- Special Investigation for VIZIMPRO Tablets (Secondary Data Collection Study; Safety and Efficacy of (N/A)
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:
- dacomitinib hydrate CI brief — competitive landscape report
- dacomitinib hydrate updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about dacomitinib hydrate
What is dacomitinib hydrate?
How does dacomitinib hydrate work?
What is dacomitinib hydrate used for?
Who makes dacomitinib hydrate?
What is the generic name of dacomitinib hydrate?
What drug class is dacomitinib hydrate in?
What development phase is dacomitinib hydrate in?
What does dacomitinib hydrate target?
Related
- Drug class: All The usual adult starting dosage for oral use is 45mg of dacomitinib hydrate once daily. The dose sho drugs
- Target: All drugs targeting Cyclin-G-associated kinase, Receptor-interacting serine/threonine-protein kinase 2, Receptor-interacting serine/threonine-protein kinase 3
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for EGFR mutation-positive, unresectable or recurrent non-small cell lung cancer
- Indication: Drugs for Non-small cell lung cancer, positive for epidermal growth factor receptor expression
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing