FDA Events for Enlivex Therapeutics (ENLV)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Enlivex Therapeutics (ENLV).
Over the past two years, Enlivex Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Allocetra. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Allocetra - FDA Regulatory Timeline and Events
Allocetra is a drug developed by Enlivex Therapeutics for the following indication: Sepsis.
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:
- Allocetra
- Announced Date:
- April 21, 2025
- Indication:
- Sepsis
Announcement
Enlivex Therapeutics Ltd. announced that the Company completed enrollment of all patients in the Phase II stage of its randomized, controlled, blinded Phase I/II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis. Overall, 133 patients were randomized and treated in the Phase II stage.
AI Summary
Enlivex Therapeutics Ltd. announced that it has completed enrolling all patients in the Phase II stage of its randomized, controlled, and blinded Phase I/II trial for Allocetra™, a potential treatment for moderate to severe knee osteoarthritis. Overall, 133 patients were randomized and treated during this stage. The trial is designed to evaluate both the safety and the effectiveness of Allocetra™ by comparing joint-pain and joint-function improvements to a placebo. Following promising early safety and efficacy results from the Phase I stage, the company is on track to provide valuable data. Enlivex plans to report 3-month topline results by August 2025, which could pave the way for new treatment options for patients suffering from knee osteoarthritis. The announcement marks a significant step in the ongoing development of this innovative immunotherapy approach.
Read Announcement- Drug:
- Allocetra
- Announced Date:
- April 3, 2025
- Indication:
- Sepsis
Announcement
Enlivex Therapeutics Ltd. announced that the first patient has been dosed in an investigator-initiated Phase I trial to evaluate the safety, tolerability and initial efficacy of Allocetra™ for injection into the temporomandibular joint (TMJ) in patients suffering from TMJ osteoarthritis.
AI Summary
Enlivex Therapeutics Ltd. has started an investigator-initiated Phase I trial to evaluate Allocetra™ for injection into the temporomandibular joint (TMJ) in patients with TMJ osteoarthritis. In this first dosing, Allocetra™ is being administered to a patient suffering from the painful, degenerative condition that affects jaw movement and chewing. The trial focuses on assessing the safety, tolerability, and initial efficacy of the therapy, which aims to help reprogram macrophages back to their normal, homeostatic state.
The study, conducted at Sheba Medical Center by its Rheumatology Unit and Department of Oral and Maxillofacial Surgery, plans to recruit six patients who have not benefited sufficiently from conventional treatments. Researchers will monitor the participants over a 12-month period to track improvements in TMJ pain and joint functionality.
Read Announcement- Drug:
- Allocetra
- Announced Date:
- March 3, 2025
- Indication:
- Sepsis
Announcement
Enlivex Therapeutics announced positive interim six-month efficacy data from the Phase I stage of its randomized, multi-country Phase I/II Allocetra™ trial in patients with moderate to severe knee osteoarthritis.
AI Summary
Enlivex Therapeutics announced positive six-month interim efficacy results from the Phase I stage of its multi-country Phase I/II Allocetra™ trial. The study focused on patients with moderate to severe knee osteoarthritis. Interim data showed a statistically significant 47% average reduction in pain compared to baseline, along with a 46% improvement in joint function and a 40% improvement in joint stiffness. At the six-month mark, 83% of patients were still considered responders. The improvement in pain and functionality appeared to be durable, consistent with the positive outcomes measured at three months, and no serious adverse events were reported.
These results highlight Allocetra™’s potential as an effective treatment for knee osteoarthritis. The trial is now moving into its Phase II stage, with continued patient recruitment and an anticipated topline data readout by the third quarter of 2025.
Read Announcement- Drug:
- Allocetra
- Announced Date:
- December 11, 2024
- Indication:
- Sepsis
Announcement
Enlivex Therapeutics Ltd. announced that the Israeli Ministry of Health authorized the initiation of an investigator-initiated Phase I trial to evaluate the safety, tolerability and initial efficacy of Allocetra™ for injection into the temporomandibular joint (TMJ) in patients suffering from TMJ osteoarthritis.
AI Summary
Enlivex Therapeutics Ltd. announced that the Israeli Ministry of Health has approved an investigator-initiated Phase I trial. The study will evaluate the safety, tolerability, and initial efficacy of Allocetra™ when injected into the temporomandibular joint (TMJ) of patients with TMJ osteoarthritis. The trial aims to enroll six patients who have not responded well to conventional treatments. Researchers will focus on monitoring the frequency and severity of adverse events as key safety endpoints, while also assessing improvements in TMJ pain, joint functionality, and other disease-related parameters over a period of up to 12 months.
The trial will be conducted by the Rheumatology Unit at Sheba Medical Center, in collaboration with the Department of Oral and Maxillofacial Surgery. This initiative represents a promising step in addressing the unmet needs of patients suffering from TMJ osteoarthritis.
Read Announcement- Drug:
- Allocetra
- Announced Date:
- September 26, 2024
- Indication:
- Sepsis
Announcement
Enlivex Therapeutics Ltd. announced that the Danish Medicines Agency authorized the initiation of the Phase II stage of the Company's multi-country Phase I/II trial in moderate and severe knee osteoarthritis.
AI Summary
Enlivex Therapeutics Ltd. announced that the Danish Medicines Agency has given the green light to start the Phase II stage of its multi-country Phase I/II trial for moderate and severe knee osteoarthritis. This decision came after a successful Phase I safety run-in and a positive recommendation from the independent Data and Safety Monitoring Board. During Phase I, the focus was on testing the safety and tolerability of Allocetra™ injections in the knee to determine the best dose and injection schedule. The next Phase II stage will be a double-blind, randomized, placebo-controlled trial designed to evaluate both the safety and efficacy of the treatment. Researchers will assess improvements in joint pain and function at three, six, and 12 months after treatment. This development marks an important step in exploring a new immunotherapy option for knee osteoarthritis patients.
Read Announcement- Drug:
- Allocetra
- Announced Date:
- September 24, 2024
- Indication:
- Sepsis
Announcement
Enlivex Therapeutics Ltd. announced that the independent Data and Safety Monitoring Board (DSMB) has completed an interim data review at the conclusion of the Phase I safety run-in stage of the Company's ongoing Phase I/II clinical trial of Allocetra™ in up to 160 patients with moderate to severe knee osteoarthritis.
AI Summary
Enlivex Therapeutics Ltd. announced that an independent Data and Safety Monitoring Board (DSMB) has completed an interim review of data at the end of the Phase I safety run-in stage in its ongoing Phase I/II clinical trial for Allocetra™. The trial involves up to 160 patients with moderate to severe knee osteoarthritis, and during the safety run-in phase, patients received three sequential injections at escalating doses. Importantly, no serious adverse reactions were reported during or after treatment. Based on this positive safety profile, the DSMB confirmed that the study can move forward to the Phase II stage. In this next phase, the trial will be double-blind and randomized, comparing intra-articular injections of Allocetra™ with a placebo while evaluating the treatment's safety and effectiveness through measures of joint pain and function at set intervals.
Read Announcement- Drug:
- Allocetra
- Announced Date:
- July 23, 2024
- Indication:
- Sepsis
Announcement
Enlivex Therapeutics Ltd. announced that the Israeli Ministry of Health has authorized the initiation of a Phase I clinical trial to evaluate the safety and tolerability of Allocetra™ following injection into an affected joint in patients with psoriatic arthritis.
AI Summary
Enlivex Therapeutics Ltd. has announced that the Israeli Ministry of Health has approved a Phase I clinical trial to study Allocetra™ for treating psoriatic arthritis. In this study, Allocetra™ will be injected into the affected joint of patients with chronic inflammatory psoriatic arthritis, a condition that causes joint pain, swelling, and stiffness. The trial will enroll six patients who have not responded well to conventional treatments. Researchers will focus on the safety and tolerability of Allocetra™, monitoring any adverse or serious side effects. Additionally, the study will assess changes in pain and other symptoms over a 12-month period. The initiation of this trial offers hope for a new treatment approach by reprogramming macrophages to restore balance in the immune system, potentially benefiting patients who suffer from this challenging condition.
Read Announcement- Drug:
- Allocetra
- Announced Date:
- June 24, 2024
- Indication:
- Sepsis
Announcement
Enlivex Therapeutics Ltd. announced that the first patient has been dosed in an investigator-initiated, randomized, placebo-controlled Phase I/II trial evaluating the efficacy and safety of Allocetra™ following injection into patients with basal thumb joint (first carpometacarpal (CMC) joint) osteoarthritis, for which conventional therapies have failed.
AI Summary
Enlivex Therapeutics Ltd. has dosed the first patient in an investigator-initiated Phase I/II trial testing Allocetra™, a novel cell therapy for basal thumb joint osteoarthritis. This degenerative condition affects the thumb’s carpometacarpal (CMC) joint and causes chronic pain and reduced function in patients who have not found relief with conventional treatments.
The trial is randomized and placebo-controlled, beginning with an open-label safety run-in phase to determine the appropriate dose. Once a safe and well-tolerated level is confirmed, the study will transition to a double-blind phase where up to 40 patients will receive either Allocetra™ or a placebo. The study aims to evaluate both the safety and effectiveness of Allocetra™ over a 12-month period, tracking adverse events and measuring improvements in pain and joint function. This approach could provide a new treatment option for patients with severe thumb osteoarthritis.
Read Announcement- Drug:
- Allocetra
- Announced Date:
- June 17, 2024
- Indication:
- Sepsis
Announcement
Enlivex Therapeutics Ltd released a positive interim data readout from a Phase I/II investigator-initiated clinical trial of AllocetraTM in patients with end-stage knee osteoarthritis who had been indicated for knee replacement surgery..
AI Summary
Enlivex Therapeutics Ltd recently shared positive interim results from its Phase I/II investigator-initiated trial using Allocetra™ in patients with end-stage knee osteoarthritis. In this study, nine patients who were candidates for knee replacement surgery received a single local injection of Allocetra™ directly into the afflicted knee. At the three‐month follow-up, patients reported an average pain reduction of 64% from baseline, with 33% of them experiencing complete pain relief—reducing their pain score from 9 to 0. Impressively, 89% of the patients chose to postpone or avoid knee replacement surgery after the treatment. The safety profile was favorable, as no severe adverse events related to Allocetra™ were observed. These findings suggest that Allocetra™ may offer an effective “last resort” treatment option for patients with severe knee osteoarthritis, potentially reducing the need for invasive surgical intervention.
Read Announcement- Drug:
- Allocetra
- Announced Date:
- June 3, 2024
- Indication:
- Sepsis
Announcement
Enlivex Therapeutics Ltd. announced that the Israeli Ministry of Health authorized the initiation of an investigator-initiated, randomized, placebo-controlled Phase I/II trial to evaluate the efficacy, safety and tolerability of Allocetra™ following injection into patients with basal thumb joint (first carpometacarpal (CMC) joint) osteoarthritis.
AI Summary
Enlivex Therapeutics Ltd. announced that the Israeli Ministry of Health has authorized the start of an investigator-initiated, randomized, placebo-controlled Phase I/II study. The trial will evaluate the safety, efficacy, and tolerability of Allocetra™ when injected into the basal thumb joint (first carpometacarpal joint) of patients suffering from osteoarthritis. This condition is very common and can be extremely painful, especially in older adults.
Led by Dr. Amir Oron from the Kaplan Medical Center in Rehovot, Israel, the study will enroll up to 46 patients in a two-stage process. The first stage will focus on safety through an open-label, dose-escalation phase, while the second stage will randomly assign patients to receive either Allocetra™ or a placebo. The trial aims to measure improvements in pain and thumb joint function over 12 months and may lead to a new, disease-modifying treatment for osteoarthritis.
Read Announcement- Drug:
- Allocetra
- Announced Date:
- April 16, 2024
- Indication:
- Sepsis
Announcement
Enlivex Therapeutics Ltd announced that the Danish Medicines Agency (DKMA) authorized the expansion into Denmark of the Company's multi-country, randomized, controlled Phase I/II trial evaluating AllocetraTM in up to 160 patients with moderate to severe knee osteoarthritis. .
AI Summary
Enlivex Therapeutics Ltd recently announced that the Danish Medicines Agency (DKMA) has approved the expansion of its multi-country, randomized, controlled Phase I/II trial into Denmark. The trial will evaluate Allocetra™, a cell therapy designed to reprogram macrophages, in up to 160 patients suffering from moderate to severe knee osteoarthritis. The study is divided into two stages. The first stage involves a safety run-in with an open-label dose escalation phase to determine the safest dose and injection schedule. The second stage is a double-blind, placebo-controlled phase that will assess the treatment’s effectiveness, with joint pain and function measured at three, six, and 12 months after treatment.
DKMA’s approval marks an important step, with Denmark expected to be the leading recruitment country due to its known high quality and strong track record in osteoarthritis studies.
Read Announcement
Enlivex Therapeutics FDA Events - Frequently Asked Questions
As of now, Enlivex Therapeutics (ENLV) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Enlivex Therapeutics (ENLV) has reported FDA regulatory activity for Allocetra.
The most recent FDA-related event for Enlivex Therapeutics occurred on April 21, 2025, involving Allocetra. The update was categorized as "Enrollment Completion," with the company reporting: "Enlivex Therapeutics Ltd. announced that the Company completed enrollment of all patients in the Phase II stage of its randomized, controlled, blinded Phase I/II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis. Overall, 133 patients were randomized and treated in the Phase II stage."
Currently, Enlivex Therapeutics has one therapy (Allocetra) targeting the following condition: Sepsis.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:ENLV) was last updated on 7/13/2025 by MarketBeat.com Staff
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