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Enliven Therapeutics (ELVN)
NASDAQ:ELVN
Elvn-001
Cml (Chronic Myelogenous Leukemia), Chronic Phase Cml
Phase I
Recruiting
ELVN-001 for the Treatment of Chronic Myeloid Leukemia With and Without T315I Mutation in Japanese Participants
Dec 16, 2024
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Trastuzumab, Oxaliplatin, Paclitaxel, Capecitabine, Leucovorin, 5-Fluorouracil, Eribulin, Elvn-002
Colorectal Cancer, Her2-Positive Breast Cancer, Her2-Positive Gastric Cancer, Her2 Amplification, Her2 Positive Solid Tumors
Phase I
Active Not Recruiting
ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer
Mar 10, 2024
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Fam-Trastuzumab Deruxtecan-Nxki, Elvn-002, Trastuzumab Emtansine
Her2-Positive Metastatic Breast Cancer, Her2 Gene Mutation, Her2 Mutant Non-Small Cell Lung Cancer, Her2 Amplification
Phase I
Active Not Recruiting
ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer
Nov 28, 2022
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Elvn-001
Chronic Myeloid Leukemia, Cml, Chronic Phase Chronic Myeloid Leukemia, Bcr-Abl1 Positive
Phase I
Recruiting
A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
Mar 15, 2022
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Imr-687
Heart Failure With Preserved Ejection Fraction
Phase II
Withdrawn
Selective PDE9 Inhibition With IMR-687 in Adults With Heart Failure With Preserved Ejection Fraction
Mar 08, 2022
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Imr-687
Sickle Cell Disease
Phase II
Terminated
A Study of IMR-687 in Subjects With Sickle Cell Disease
Jun 26, 2020
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Imr-687
Β Thalassemia
Phase II
Terminated
A Study of IMR-687 in Subjects With Beta Thalassemia
Apr 15, 2020
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Imr-687
Sickle Cell Disease
Phase II
Completed
A Study of IMR-687 in Adult Participants With Sickle Cell Anemia (Homozygous HbSS or Sickle-β0 Thalassemia)
Jan 02, 2018
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Imr-687
Sickle Cell Disease, Sickle-Cell; Hb-Sc, Sickle Beta 0 Thalassemia
Phase I
Completed
A Study of IMR-687 in Healthy Adult Volunteers
Dec 06, 2016
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Enliven Therapeutics (ELVN) have in its pipeline
ELVN is currently developing the following drugs: Elvn-001, Trastuzumab, Oxaliplatin, Paclitaxel, Capecitabine, Leucovorin, 5-Fluorouracil, Eribulin, Elvn-002, Fam-Trastuzumab Deruxtecan-Nxki, Elvn-002, Trastuzumab Emtansine. These drug candidates are in various stages of clinical development as the company works toward FDA approval.