This section highlights FDA-related milestones and regulatory updates for drugs developed by Entrada Therapeutics (TRDA).
Over the past two years, Entrada Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ELEVATE-44-201, ENTR-601-44, ENTR-601-44-101, and ENTR-601-45. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ELEVATE-44-201 - FDA Regulatory Timeline and Events
ELEVATE-44-201 is a drug developed by Entrada Therapeutics for the following indication: For Duchenne Muscular Dystrophy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ELEVATE-44-201
- Announced Date:
- March 24, 2025
- Indication:
- For Duchenne Muscular Dystrophy
Announcement
Entrada Therapeutics, Inc. announced it has received authorization from the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee to initiate ELEVATE-45-201.
AI Summary
Entrada Therapeutics, Inc. announced that the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) and a Research Ethics Committee have authorized the start of the ELEVATE-45-201 study. This study is a global, Phase 1/2, multiple ascending dose clinical trial evaluating the safety, tolerability, and effectiveness of their investigational product, ENTR-601-45, in patients with Duchenne muscular dystrophy who are amenable to exon 45 skipping. The trial will be conducted in two parts, starting with a dose escalation phase followed by an expansion phase to determine the optimal dose based on safety and potential benefits.
The company is on track to begin the ELEVATE-45-201 study in the third quarter of 2025. This milestone is a key step in expanding Entrada’s Duchenne muscular dystrophy program, which aims to address the underlying genetic causes of the disease and improve the quality of life for patients.
Read Announcement- Drug:
- ELEVATE-44-201
- Announced Date:
- February 27, 2025
- Indication:
- For Duchenne Muscular Dystrophy
Announcement
Entrada Therapeutics, Inc highlighted recent business updates.
AI Summary
Entrada Therapeutics announced key business updates that mark a strong start to 2025. The company received FDA authorization to initiate the Phase 1b ELEVATE-44-102 study in the U.S., which will evaluate ENTR-601-44 for Duchenne muscular dystrophy in patients amenable to exon 44 skipping. In addition, the U.K.’s MHRA authorized the ELEVATE-44-201 study, expected to begin in Q2 2025. Entrada also submitted regulatory filings to begin global clinical studies, including the Phase 1/2 trial of ENTR-601-45 in the U.K. and the EU. CEO Dipal Doshi emphasized that these milestones demonstrate the company’s commitment to creating a best-in-class therapy. With a strong cash position of $420 million supporting its operations through Q2 2027, Entrada is confident in its progress and ability to deliver impactful treatments for patients and value to investors.
Read Announcement- Drug:
- ELEVATE-44-201
- Announced Date:
- February 3, 2025
- Indication:
- For Duchenne Muscular Dystrophy
Announcement
Entrada Therapeutics announced it had received authorization from the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee for its Clinical Trial of an Investigational Medicinal Product to initiate ELEVATE-44-201, a Phase 1/2 multiple ascending dose (MAD) clinical study of ENTR-601-44 for the potential treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation in the DMD gene amenable to exon 44 skipping.
AI Summary
Entrada Therapeutics announced that its clinical trial, ELEVATE-44-201, has received authorization from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee. The study, which is a Phase 1/2 multiple ascending dose trial, will evaluate ENTR-601-44 for the potential treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed DMD gene mutation amenable to exon 44 skipping.
This trial aims to establish a safe and effective dose of ENTR-601-44 while exploring its impact on the disease’s progression. The clearance by the MHRA is a significant step forward in Entrada’s commitment to offering new treatment options for patients with DMD, a condition that severely limits muscle function and overall quality of life. The company plans to initiate the study in the United Kingdom in the second quarter of 2025.
Read Announcement- Drug:
- ELEVATE-44-201
- Announced Date:
- February 3, 2025
- Estimated Event Date Range:
- April 1, 2025 - June 30, 2025
- Target Action Date:
- Q2 2025
- Indication:
- For Duchenne Muscular Dystrophy
Announcement
Entrada Therapeutics, Inc. announced that Company on track to initiate ELEVATE-44-201 in Q2 2025 –
AI Summary
Entrada Therapeutics, Inc. announced that it is on track to begin its Phase 1/2 clinical study known as ELEVATE-44-201 in the second quarter of 2025. This study will evaluate the investigational drug ENTR-601-44, which is being developed to treat patients with Duchenne muscular dystrophy who have a mutation that makes them amenable to exon 44 skipping. The clinical trial will be a global, multiple ascending dose study involving ambulatory patients. It aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug. The study is organized in two parts, where Part A involves varying dosage levels and Part B focuses on determining the optimal dose based on safety and efficacy, along with patient-reported outcomes. Regulatory filings have also been submitted in additional regions, including the U.S. and EU, with discussions ongoing.
Read Announcement
ENTR-601-44 - FDA Regulatory Timeline and Events
ENTR-601-44 is a drug developed by Entrada Therapeutics for the following indication: Duchenne muscular dystrophy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ENTR-601-44
- Announced Date:
- October 9, 2024
- Indication:
- Duchenne muscular dystrophy
Announcement
Entrada Therapeutics, Inc. announced the presentation of clinical and preclinical data in support of its expanding Duchenne clinical franchise at the 29th Annual Congress of the World Muscle Society in Prague, Czechia from October 8-12, 2024.
AI Summary
Entrada Therapeutics, Inc. announced that it will present important clinical and preclinical data during the 29th Annual Congress of the World Muscle Society in Prague, Czechia, from October 8-12, 2024. The company is showcasing expanding research in its Duchenne clinical franchise, which includes data from a completed Phase 1 trial for ENTR-601-44. This Phase 1 study demonstrated a strong safety profile at the highest doses, with no adverse events or significant changes in kidney biomarkers, supporting plans for a global Phase 2 clinical trial filing later this year. Additionally, Entrada introduced preclinical findings for ENTR-601-45, revealing encouraging results with robust exon skipping and improved dystrophin production that led to enhanced muscle function in animal models. These findings underline the potential of Entrada’s therapies to address Duchenne Muscular Dystrophy in patients amenable to exon 44 and exon 45 skipping.
Read Announcement
ENTR-601-44-101 - FDA Regulatory Timeline and Events
ENTR-601-44-101 is a drug developed by Entrada Therapeutics for the following indication: For Duchenne Muscular Dystrophy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ENTR-601-44-101
- Announced Date:
- June 24, 2024
- Indication:
- For Duchenne Muscular Dystrophy
Announcement
Entrada Therapeutics, Inc announced that Phase 2 planning underway for separate ENTR-601-44.
AI Summary
Entrada Therapeutics announced that it is planning separate Phase 2 clinical trials for its investigational molecule ENTR-601-44. The decision follows encouraging preliminary results from the Phase 1 study, where ENTR-601-44 was well tolerated in healthy volunteers with no serious or drug-related adverse events. The trial showed that the drug reached significant plasma and muscle concentrations and achieved meaningful exon skipping levels. These findings suggest that a clinically relevant starting dose has been identified for patient trials.
The company now anticipates submitting regulatory filings for the global Phase 2 trials in the fourth quarter of 2024. This next phase focuses on patients with Duchenne Muscular Dystrophy who are exon 44 skipping amenable. Entrada believes the positive safety profile and target engagement results indicate promising potential for improving patient outcomes in this progressive neuromuscular disease.
Read Announcement- Drug:
- ENTR-601-44-101
- Announced Date:
- June 24, 2024
- Indication:
- For Duchenne Muscular Dystrophy
Announcement
Entrada Therapeutics, Inc. announced positive preliminary data from its Phase 1 clinical trial, ENTR-601-44-101.
AI Summary
Entrada Therapeutics announced positive preliminary data from its Phase 1 clinical trial, ENTR-601-44-101, for its lead treatment aimed at Duchenne muscular dystrophy. In the trial, healthy volunteers received single doses of the investigational drug, and results showed it was well-tolerated with no serious or drug-related adverse events. No significant changes were noted in vital signs, ECGs, physical exams, or laboratory tests. Additionally, the study demonstrated promising pharmacokinetic results, as evidenced by significant plasma and muscle concentrations and effective exon skipping. These findings indicate that the chosen dose reaches levels that could be clinically meaningful for further testing.
The data have played a key role in establishing a starting dose for planned global Phase 2 clinical trials in patients with Duchenne, especially those amenable to exon 44 skipping. This progress marks an encouraging step toward potentially transforming treatment options for this progressive neuromuscular disease.
Read Announcement
ENTR-601-45 - FDA Regulatory Timeline and Events
ENTR-601-45 is a drug developed by Entrada Therapeutics for the following indication: In patients with Duchenne who are exon 45 skipping amenable.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ENTR-601-45
- Announced Date:
- May 28, 2025
- Indication:
- In patients with Duchenne who are exon 45 skipping amenable
Announcement
Entrada Therapeutics, Inc. announced it has received authorization from the Health Authorities and Ethics Committees of multiple countries under the European Union Clinical Trial Regulation (EU-CTR) to initiate ELEVATE-45-201, a Phase 1/2 multiple ascending dose (MAD) clinical study of ENTR-601-45 in patients living with Duchenne muscular dystrophy (DMD) who are amenable to exon 45 skipping.
AI Summary
Entrada Therapeutics has received approval from multiple European Union Health Authorities and Ethics Committees under the EU Clinical Trial Regulation (EU-CTR) to start its ELEVATE-45-201 study. This Phase 1/2 clinical trial will use a multiple ascending dose design to assess ENTR-601-45 in patients with Duchenne muscular dystrophy (DMD) who are amenable to exon 45 skipping. The study will include two parts: the first will evaluate safety, pharmacokinetics, and pharmacodynamics, including the levels of exon skipping and dystrophin production in roughly 24 patients receiving varying doses; the second will further examine the optimal dose for safety and effectiveness while monitoring functional outcomes and quality of life. The trial, which is on track to begin in Q3 2025, is seen as a major step forward for addressing unmet needs in a large subpopulation of DMD patients.
Read Announcement- Drug:
- ENTR-601-45
- Announced Date:
- October 9, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 2024
- Indication:
- In patients with Duchenne who are exon 45 skipping amenable
Announcement
Entrada Therapeutics, Inc. Preclinical data presented for the first time, showing exon skipping and dystrophin production for ENTR-601-45, supports the planned Q4 2024 regulatory filings for a global direct-to-patient Phase 2 clinical trial –
AI Summary
Entrada Therapeutics, Inc. presented new preclinical data for its candidate ENTR-601-45 at the 29th Annual Congress of the World Muscle Society. The data, shown for the first time, demonstrated that ENTR-601-45 produces a robust, dose-dependent response that results in exon skipping and significant dystrophin protein restoration in both laboratory and animal models. In a mouse model of Duchenne muscular dystrophy, the treatment led to improved skeletal muscle function, with the highest dose showing dystrophin levels comparable to those in healthy controls. These promising results support Entrada’s planned Q4 2024 regulatory filings for a global, direct-to-patient Phase 2 clinical trial aimed at patients with exon 45 skip-amenable Duchenne. The data highlight the potential of ENTR-601-45 as a transformative treatment option, underscoring the company’s commitment to developing innovative therapies for neuromuscular disorders.
Read Announcement- Drug:
- ENTR-601-45
- Announced Date:
- June 24, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- Q4 2024
- Indication:
- In patients with Duchenne who are exon 45 skipping amenable
Announcement
Entrada Therapeutics, Inc. announced that ENTR-601-45 clinical trials with regulatory filings anticipated in Q4 2024
AI Summary
Entrada Therapeutics revealed plans to submit regulatory filings in the fourth quarter of 2024 to launch separate global Phase 2 clinical trials. Among these, the study for ENTR-601-45, which targets patients with Duchenne muscular dystrophy who are exon 45 skipping amenable, is a key focus of this new phase. This announcement follows the company’s ongoing development efforts to create potential treatments using its innovative Endosomal Escape Vehicle (EEV) platform. In addition to the ENTR-601-45 trial, a separate Phase 2 trial for ENTR-601-44 is also in the works. The upcoming filings mark an important step toward expanding clinical research and, ultimately, offering new therapeutic options for patients with this debilitating neuromuscular disease.
Read Announcement
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