Data updated: May 26, 2026
KHAPZORY (levoleucovorin)
Trial Activity: Growth 8 active trials
Oncology
Approved 2018-10-19
Development Insights
Merck Sharp & Dohme LLC conducting 4 trials (40%)
24 indications explored (Broad Platform)
→ b acute lymphoblastic leukemia (2 trials)
→ colorectal neoplasms (2 trials)
→ acute leukemia of ambiguous lineage (1 trials)
1
Indication
--
Phase 3 Trials
7
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2018-10-19
- Patent Cliff
- 2039
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
KHAPZORY Approval History
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2018 to 2020
What KHAPZORY Treats
1 FDA approvalsOriginally approved for its first indication in 2018 .
- Other (1)
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Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04210115 | 3475-975 MK-3475-975, KEYNOTE-975 | Ph 3 | active not recruiting | Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975) |
| NCT06317662 | NCI-2024-01994 NCI-2024-01994, AALL2321 | Ph 2 | recruiting | Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia |
| NCT03007147 | AALL1631 NCI-2016-01588, AALL1631 | Ph 3 | active not recruiting | Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia |
| NCT06469944 | 3475-06C MK-3475-06C, KEYMAKER-06C | Ph 1, Ph 2 | recruiting | Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06) |
| NCT05945823 | TAS-120-206 | Ph 2 | active not recruiting | Phase 2 Futibatinib in Combination With PD-1 Antibody Based Standard of Care in Solid Tumors |
| NCT05253651 MOUNTAINEER-03 | SGNTUC-029 C4251008, 2024-514180-25-00 | Ph 3 | recruiting | A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer |
| NCT06780111 | 3475-06E MK-3475-06E, 2024-514273-22-00 | Ph 1, Ph 2 | recruiting | Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06) |
| NCT04949256 | 7902-014 MK-7902-014, LEAP-014 | Ph 3 | active not recruiting | Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014) |
| NCT03698461 CLIMB | ASA-1 | Ph 2 | completed | Treatment of Colorectal Liver Metastases With Immunotherapy and Bevacizumab |
| NCT03222089 | FNF-006 | Ph 2 | withdrawn | Phase II Trial of FOLFOXIGIL Versus FOLFOXIRI as First-line Therapy in Patients With mCRC |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
KHAPZORY FDA Label Details
View full patent landscape →
1 OB patents · 1 families ·
2 international docs across 1 countries
KHAPZORY Patents & Exclusivity
Latest Patent: Mar 2039
Patents (1 active)
US11541012
Expires Mar 25, 2039
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for KHAPZORY
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 4 active patents
Trial Analysis
- • 10 total trials
- • Stage: Growth
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment