drug
ML-061
Marketedupdated 4mo agoby Meridian Laboratories Inc
Approvedcommunity read0 votes
Small molecule drug with a maximum clinical stage of Approval (across all indications), with 11 approved and 71 investigational indications.
indications
investigational
NSCLC
all catalysts(0)
nothing on the calendar yet
Trials studying ML-061
- phase2Anti-HER2 Bispecific Antibody Zanidatamab (ZW25) Activity in Combination With Chemotherapy With/Without Tislelizumab
- phase2A Study to Evaluate the Safety and Efficacy of NDV-01 in Participants With NMIBC
- phase3A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations
- phase3A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
- phase2Toripalimab With Chemotherapy for Sinus Cancer
- phase3A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer
- phase3A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29)
- phase3FH-006 Versus Investigator's Choice of Chemotherapy in Patients With Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma Who Have Failed Prior PD-1/PD-L1 Inhibitor Combined With Platinum-Based Chemotherapy.
Patent cliff
source: FDA Orange Bookfirst barrier falls
Aug 7, 2031
~4.9 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (18)
- May 16, 2036formulationUS 11419842
- May 16, 2036formulationUS 12090134
- May 16, 2036formulationUS 12090135
- Mar 14, 2036formulationUS 10398785
- Mar 14, 2036formulationUS 10398785
- Mar 14, 2036formulationUS 10398785
- Sep 30, 2033formulationUS 8940786
- Sep 30, 2033formulationUS 8940786
- Sep 30, 2033formulationUS 8940786
- Sep 30, 2033formulationUS 9308195
- Sep 30, 2033formulationUS 9308195
- Sep 30, 2033formulationUS 9308195
- Sep 30, 2033method-of-use (U-2562)US 9763880
- Sep 30, 2033method-of-use (U-2559)US 9763880
- Sep 30, 2033method-of-use (U-2560)US 9763880
- Aug 7, 2031formulationUS 108427704.9y
- Aug 7, 2031formulationUS 108427704.9y
- Aug 7, 2031formulationUS 108427704.9y
News(3)
- GU Cancer Experts Highlight Top Abstracts to Watch During ASCO 2026We spoke with leading voices in GU oncology to see which presentations they are most looking forward to during the 2026 ASCO Annual Meeting.onclive · 3mo ago
- Poll Results Highlight Breast Cancer Abstracts of Interest at ASCO 2026Readers share their opinions on some of the most talked-about breast cancer abstracts they’re looking forward to seeing at ASCO 2026.onclive · 3mo ago
- ASCO 2026 HR+ and HER2+ Breast Cancer Preview: Read up on the Insights to Know Before You GoBreast cancer experts spotlight the abstracts they’re most excited to see at the 2026 ASCO Annual Meeting.onclive · 3mo ago
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