drug · small molecule
osimertinib mesylate
Marketedupdated 5mo agoby $AZN ASTRAZENECA PLC🔗 ChEMBL
Approvedannual revenue · 2024–2024peak $6.6B
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Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for non-small cell lung carcinoma and 1 investigational indication.
indications
investigational
NSCLC
targets
Epidermal growth factor receptor
all catalysts(0)
nothing on the calendar yet
Trials studying osimertinib mesylate
- phase1Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancer
- phase3A Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases
- phase2A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancer
- phase2A Study to Evaluate Safety and Efficacy of WSD0922-FU Combo With Osimertinib for NSCLC
- phase1A Study of APG-1252 Plus Osimertinib(AZD9291) in EGFR TKI Resistant NSCLC Patients
- phase2A Study of BL-B01D1 and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
- phase2A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
- phase2A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumors
Patent cliff
source: FDA Orange Bookfirst barrier falls
Feb 16, 2027
134 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (10)
- Nov 26, 2042method-of-use (U-3823)US 12465608
- Nov 26, 2042method-of-use (U-3823)US 12465608
- Jan 2, 2035formulationUS 10183020
- Jan 2, 2035formulationUS 10183020
- Aug 8, 2032compositionUS 8946235
- Aug 8, 2032compositionUS 8946235
- Jul 25, 2032compositionUS 11524951
- Jul 25, 2032compositionUS 11524951
- Jul 25, 2032compositionUS 9732058
- Jul 25, 2032compositionUS 9732058
FDA exclusivities (6)
- Dec 18, 2027ODE-337Orphan Drug (7y)1.2y
- Dec 18, 2027ODE-337Orphan Drug (7y)1.2y
- Sep 25, 2027I-952Indication (3y)355d
- Sep 25, 2027I-952Indication (3y)355d
- Feb 16, 2027I-941Indication (3y)134d
- Feb 16, 2027I-941Indication (3y)134d
News(10)
- Rare EGFR mutation increases lung cancer risk 62 times in never smokersA rare inherited germline mutation was found to increase risk for lung cancer by 25 times, while smoking only increased risk by 4 times.fiercebiotech · 17d ago
- WCLC ‘26: A new ‘ADC era,’ China questions and AstraZeneca’s spotlightThe year’s biggest meeting on lung cancer research featured data suggesting a new treatment standard for an aggressive tumor as well as debate about the reliability of results from China-run studies.biopharma_dive · 19d ago
- Cullinan, Taiho showcase 6-month survival benefit in phase 3 trial for advanced lung cancerCullinan Therapeutics and Taiho Oncology unveiled phase 3 data showing survival improvements greater than Johnson & Johnson’s Rybrevant in patients with advanced non-small cell lung cancer in the f…fiercebiotech · 23d ago
- GSK pens $1.3B Hutchmed deal for early-stage KRAS-EGFR cancer assetGSK is handing over $110 million upfront to Hutchmed in a deal worth up to $1.295 billion to get its hands on a first-in-class oncology candidate.fiercebiotech · 1mo ago
- AstraZeneca scores in lung cancer; Sandoz inks a China dealA combination of AstraZeneca’s Tagrisso and Hutchmed’s Orpathys extended survival for some lung cancer patients. Elsewhere, MapLight floated the idea of partnering on its autism drug.biopharma_dive · 1mo ago
- AstraZeneca touts separate late-stage lung cancer wins with Tagrisso, EnhertuAstraZeneca on Monday reported successes in two late-stage trials in different forms of lung cancer — one with a two-drug combination of Tagrisso and Orpathys and another with its blockbuster antib…endpoints · 1mo ago
- New Taiho, Cullinan data heats up lung cancer drug battleThe findings position their drug, zipalertinib, as a threat to multiple approved medicines — while setting a bar for others in testing.biopharma_dive · 1mo ago
- BlossomHill, Latigo outshine IPO expectations with oversubscribed debutsTwo growing biotechs blasted through their IPO expectations Friday, with Blossom Hill Therapeutics and Latigo Biotherapeutics each raising at least 30% more than expected in their stock market debuts.fiercebiotech · 1mo ago
- Latigo laces up for $247M IPO to fund non-opioid pain drug rival to Vertex’s JournavxLatigo Biotherapeutics has fleshed out its plans for an IPO to finance the development of its clinical-stage pipeline of non-opioid pain management drugs.fiercebiotech · 2mo ago
- ‘Unlikely’ AstraZeneca-BMS mega-merger would be largest pharma deal everIf AstraZeneca and Bristol Myers Squibb were to successfully become one company, analysts say it could reset the current deal environment, which has picked up greatly in the first half of the year.biospace · 2mo ago
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