Drugs / ENTR-601-44
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Clinical hold | US (FDA) | — | DMD-related muscular dystrophy | 2022-12-19 | “clinical hold notice from the U.S. Food and Drug Administration (FDA) regarding their Investigational New Drug Application (IND) for ENTR-601-44” entradatx.com ↗ “In December 2022, the U.S. Food and Drug Administration (FDA) placed the Investigational New Drug (IND) application on hold for ENTR-601-44” entradatx.com ↗ “Entrada was previously notified by the FDA that the IND for the Phase 1 clinical trial of ENTR-601-44 had been placed on clinical hold.” entradatx.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07037862 | Jun 2025 → Mar 2029 expected | Duchenne muscular dystrophy | Entrada Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07682129 | Aug 2026 → Mar 2032 expected | Duchenne muscular dystrophy | Entrada Therapeutics, Inc. | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-05-07 | Entrada Therapeutics, Inc. | Results Entrada Therapeutics Announces Positive Topline Results from Cohort 1 of Participants with Duchenne Muscular Dystrophy Treated with ENTR-601-44 in Phase 1/2 ELEVATE-44-201 Study entradatx.com ↗ |
| 2025-05-08 | Entrada Therapeutics, Inc. | Regulatory Entrada Therapeutics Reports First Quarter 2025 Financial Results entradatx.com ↗
We are excited to announce the first European Union regulatory clearance within our Duchenne franchise, with the authorization to initiate the ELEVATE-44-201 patient study across multiple countries. |
| 2025-02-24 | Entrada Therapeutics, Inc. | Regulatory Entrada Therapeutics Announces FDA Removal of Clinical Hold on ENTR-601-44 entradatx.com ↗
Receives FDA authorization to initiate ELEVATE-44-102, a Phase 1b multiple ascending dose clinical study of ENTR-601-44 in adults living with Duchenne muscular dystrophy |
| 2025-02-03 | Entrada Therapeutics, Inc. | Regulatory Entrada Therapeutics Receives Authorization in the United Kingdom to Initiate ELEVATE-44-201, a Phase 1/2 Multiple Ascending Dose Clinical Study of ENTR-601-44 in Patients Living with Duchenne Muscular Dystrophy entradatx.com ↗ |
| 2024-10-09 | Entrada Therapeutics, Inc. | Results Entrada Therapeutics Presents New Data Supporting its Expanding Duchenne Franchise at the 29th Annual Congress of the World Muscle Society entradatx.com ↗
We are also pleased to present new data from preclinical studies of ENTR-601-45, showing compelling in vivo dystrophin production and functional improvement,” said Natarajan Sethuraman, PhD, President of R&D at Entrada Therapeutics. |
| 2024-06-24 | Entrada Therapeutics, Inc. | Results Entrada Therapeutics Reports Positive Preliminary Data in Healthy Volunteers from Phase 1 ENTR-601-44-101 Trial for Duchenne Muscular Dystrophy entradatx.com ↗
ENTR-601-44 was well tolerated in healthy volunteers and we are pleased to see significant plasma concentration, muscle concentration and exon skipping. |
| 2023-08-01 | Entrada Therapeutics, Inc. | Regulatory Entrada Therapeutics Receives Authorization in the United Kingdom to Initiate Phase 1 Clinical Trial of ENTR-601-44 for the Potential Treatment of Duchenne Muscular Dystrophy entradatx.com ↗
Entrada Therapeutics, Inc. (Nasdaq: TRDA), a biopharmaceutical company aiming to transform the lives of patients by establishing intracellular Endosomal Escape Vehicle (EEV™)-therapeutics as a new class of medicines, today announced that it has received authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) and Research Ethics Committee (REC) for its CTIMP (Clinical Trial of an Investigational Medicinal Product) for a Phase 1 clinical trial in healthy volunteers for ENTR-601-44. |
| 2022-12-19 | Entrada Therapeutics, Inc. | Regulatory Entrada Therapeutics Announces Clinical Hold on IND Application for ENTR-601-44 in Duchenne Muscular Dystrophy entradatx.com ↗
today announced that the Company received a clinical hold notice from the U.S. Food and Drug Administration (FDA) regarding their Investigational New Drug Application (IND) for ENTR-601-44 for the potential treatment of Duchenne muscular dystrophy. |
| 2022-05-11 | Entrada Therapeutics, Inc. | Results Entrada Therapeutics Presents New Data Supporting its Growing Pipeline of Endosomal Escape Vehicle (EEV™) Therapeutics at TIDES USA 2022 entradatx.com ↗
The company announced new non-human primate (NHP) data demonstrating durability of response through 12 weeks for ENTR-601-44, an EEV-conjugated phosphorodiamidate morpholino oligomer (PMO) for the potential treatment of people with Duchenne muscular dystrophy (DMD) who are exon 44 skipping amenable. |
All press releases naming this drug 12 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ENTR-601-44 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07682129 ↗ |
| Route | Intravenous | “Participants will: * Receive study treatment in the form of multiple intravenous (IV) infusions (slow injection) into a vein” NCT07037862 ↗ |