Enlivex Therapeutics (ENLV) FDA Approvals

Enlivex Therapeutics' Drug in the FDA Approval Process

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.

Dose Update - May 18,2026

Phase 2b

• Drug: Allocetra
• Announced Date: May 18, 2026
• Indication: Sepsis

Enlivex Ltd. y announced the dosing of the first patient at a United States clinical site in the Phase 2b clinical trial of Allocetra™ for the treatment of patients with moderate-to-severe age-related symptomatic primary knee osteoarthritis (OA).

Enlivex Ltd. said it has dosed the first patient at a U.S. clinical site in its Phase 2b trial of Allocetra™ for moderate-to-severe age-related primary knee osteoarthritis. This is an important step in the company’s effort to test whether the treatment can help reduce pain and improve function for people living with this common joint disease.

The study is now moving forward in the United States as Enlivex expands enrollment. Knee osteoarthritis can cause pain, stiffness, and difficulty walking or doing everyday activities, so new treatment options are needed. By starting patient dosing at a U.S. site, the company is advancing its late-stage clinical program and gathering more data on Allocetra™’s safety and possible benefits.

Clinical trial application - April 21,2026

• Drug: Allocetra
• Announced Date: April 21, 2026
• Indication: Sepsis

Enlivex Ltd. announced that it has received Clinical Trial Application (CTA) approval by the Danish Medicines Agency (DKMA) for the Phase 2b trial of Allocetra™, the Company's clinical-stage immunotherapy, for the treatment of patients with moderate-to-severe age-related symptomatic primary knee osteoarthritis (OA).

Enlivex Ltd. announced that the Danish Medicines Agency (DKMA) has approved its Clinical Trial Application to enroll patients in Denmark for a Phase 2b study of Allocetra™. The trial will test Allocetra in people with moderate-to-severe age-related symptomatic primary knee osteoarthritis.

The Phase 2b study is statistically powered to evaluate key efficacy endpoints versus placebo. Primary measures include change from baseline in pain and physical function, assessed at three and six months after treatment. Additional endpoints will track quality-of-life measures and functional mobility assessments to capture broader effects on daily function.

Allocetra is an advanced clinical-stage immunotherapy aimed at modulating inflammatory processes associated with aging. With DKMA approval, Enlivex can now recruit Danish patients to further assess Allocetra’s potential to relieve symptoms and improve function in age-related knee osteoarthritis.

FDA Clearance - March 23,2026

IND

• Drug: Allocetra
• Announced Date: March 23, 2026
• Indication: Sepsis

Enlivex Ltd. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Allocetra™, the Company's clinical-stage immunotherapy, for the treatment of patients with moderate-to-severe age-related symptomatic primary knee osteoarthritis (OA).

Enlivex Ltd. announced that the U.S. Food and Drug Administration has cleared its Investigational New Drug (IND) application for Allocetra™, the company’s clinical-stage immunotherapy, to treat patients with moderate-to-severe age-related symptomatic primary knee osteoarthritis (OA). Allocetra is intended to target inflammation linked to aging and OA, and the IND clearance allows Enlivex to proceed with clinical testing in the United States.

The planned Phase 2b trial is designed to be statistically powered to assess key efficacy endpoints. Primary measures will compare change from baseline in pain and physical function versus placebo, evaluated at three and six months after treatment. Additional endpoints include changes in quality-of-life measures and functional mobility assessments, which will help determine the therapy’s overall impact on patient symptoms and daily activity.Read Announcement

Efficacy Data - November 24,2025

Phase 2a

• Drug: Allocetra
• Announced Date: November 24, 2025
• Indication: Sepsis

Enlivex Therapeutics Ltd. announced positive six-month efficacy data from the Phase IIa stage of its randomized, multi-country Phase I/II Allocetra™ trial (ENX-CL-05-001) in patients with moderate to severe knee osteoarthritis (OA).

Enlivex Therapeutics reported positive six-month efficacy data from the Phase IIa stage of its randomized, multi-country Phase I/II Allocetra trial (ENX-CL-05-001) in patients with moderate to severe knee osteoarthritis. The six-month follow-up is complete and the results reaffirm the earlier three-month findings, identifying an age-related primary responder group.

In patients aged about 60 and older, Allocetra produced a substantial and durable reduction in pain and improvement in function compared with placebo. The company highlighted a composite pain/function endpoint that reached statistical significance: at three months (age 60+) the treated group improved -26.8 versus -13.4 for placebo (99% relative improvement; p=0.008), and at six months (age 61+) -27.8 versus -15.5 (80% relative improvement; p=0.02). Allocetra also continued to show a favorable safety profile through six months.

Enlivex says these data support moving to a Phase IIb trial of Allocetra in age-related primary knee OA, planned for the first half of 2026.

Late-breaking abstract - October 28,2025

• Drug: Allocetra
• Announced Date: October 28, 2025
• Indication: Sepsis

Enlivex Therapeutics Ltd. announced that it will present a late-breaking poster abstract at the American College of Rheumatology (ACR) Convergence 2025, taking place October 24–29 at McCormick Place Convention Center in Chicago, Illinois.

Enlivex Therapeutics Ltd. (NASDAQ: ENLV) announced it will present a late-breaking poster abstract at the American College of Rheumatology (ACR) Convergence 2025 conference. The event takes place October 24–29 at McCormick Place Convention Center in Chicago, Illinois.

The poster will share 3-month topline results from the Phase IIa ENX-CL-05-001 trial of Allocetra™ in moderate-to-severe knee osteoarthritis patients. Data show significant reductions in pain and improvements in function compared to placebo in idiopathic, age-related osteoarthritis patients 60 years or older, who make up over half of both the market and study group. New biomarker insights will also be discussed.

Professor Philip Conaghan, a leading rheumatologist from the NIHR Leeds Biomedical Research Centre, will present the findings on October 28 from 10:30 AM to 12:30 PM (Abstract ID: 2220562). Enlivex’s CMO, Dr. Einat Galamidi, will attend the conference and meet with stakeholders and scientists.

Provided Update - September 11,2025

• Drug: Allocetra
• Announced Date: September 11, 2025
• Indication: Sepsis

Enlivex Therapeutics Ltd. today issued the following update to shareholders from Chief Executive Officer, Oren Hershkovitz, highlighting the strength of its recently announced Phase IIa topline results for Allocetra™ in knee osteoarthritis (KOA) and detailing the next steps planned for its clinical development roadmap.

In a letter to shareholders, CEO Oren Hershkovitz highlighted the strong Phase IIa topline results for Allocetra in moderate-to-severe knee osteoarthritis. After three months, patients treated with Allocetra experienced statistically significant and clinically meaningful improvements in both pain and joint function.

Analysts and key opinion leaders praised the data. Biotech analyst Jason Kolbert described the results as “truly exceptional,” while Prof. Ali Mobasheri noted the impressive effects in patients aged 60 and over. In this age-related group, Allocetra achieved a 72% reduction in pain versus placebo and a 109% improvement in function. The treatment was well tolerated, with no serious drug-related adverse events reported.

Enlivex’s next steps include a six-month Phase IIa readout in November 2025, expected protocol approval for Phase IIb in early 2026, first patient dosing by mid-2026, and topline Phase IIb data by mid-2027. The company is pursuing partnerships and non-dilutive funding to support these milestones.

Hershkovitz concluded that these findings position Allocetra to address a major unmet need in knee osteoarthritis and bring lasting value to patients and shareholders.

Top-line results - August 18,2025

• Drug: Allocetra
• Announced Date: August 18, 2025
• Indication: Sepsis

Enlivex Announces Positive Topline Data From Multi-Country, Randomized, Controlled, Phase I/II Trial Evaluating Allocetra in Patients With Moderate-To-Severe Knee Osteoarthritis

Enlivex Therapeutics announced positive three-month topline results from ENX-CL-05-001, a multi-country, randomized, double-blind, placebo-controlled Phase I/II trial testing Allocetra™ in patients with moderate-to-severe knee osteoarthritis. The study included a safety run-in and dose-escalation Phase I stage, followed by a Phase IIa stage assessing joint pain and function at three, six, and 12 months post-treatment.

In the modified intention-to-treat population, patients receiving Allocetra™ experienced a 24% reduction in knee pain and a 26% improvement in knee function compared with placebo. In the subgroup with age-related primary osteoarthritis, Allocetra™ achieved a 72% drop in pain and a 95% gain in function versus placebo. These effects were both clinically meaningful and statistically significant on common Phase III endpoints for knee osteoarthritis.

The safety profile was favorable, with no severe adverse events and mostly mild to moderate, transient side effects that were easily managed. Enlivex will host a webinar today at 8:00 a.m. Eastern Time to discuss these findings in detail.

Presentation - August 14,2025

Phase 2a

• Drug: Allocetra
• Announced Date: August 14, 2025
• Indication: Sepsis

Enlivex Therapeutics Ltd. announced it will host a webinar on Monday, August 18, 2025, at 8:00 AM Eastern Time to present and discuss 3-month topline results from the Phase IIa stage of its Phase I/IIa ENX-CL-05-001 trial, a double-blind, randomized, placebo-controlled multi-centered study.

Enlivex Therapeutics Ltd. will host a webinar on Monday, August 18, 2025, at 8:00 AM Eastern Time to present and discuss the 3-month topline results from the Phase IIa stage of its ENX-CL-05-001 trial. Register now to join the free event and hear detailed data on Allocetra’s performance in knee osteoarthritis.

The ENX-CL-05-001 trial is a multi-center, double-blind, randomized, placebo-controlled Phase I/IIa study of Allocetra in patients with moderate-to-severe knee osteoarthritis. The first stage tested safety and dose levels, and the ongoing Phase IIa stage will measure joint pain and function at 3, 6, and 12 months. An interim analysis by a third party supported expanding enrollment from 130 to 180 patients. To date, 134 patients have completed the 3-month follow-up, the trial’s primary time point.

Webinar registrants will get an in-depth look at the topline data and next trial steps.

Provided Update - July 28,2025

Phase 2

• Drug: Allocetra
• Announced Date: July 28, 2025
• Indication: Sepsis

Enlivex Therapeutics Ltd announced that all 134 patients in its Phase II stage of its randomized, controlled, blinded Phase I/II trial of Allocetra™ in patients with moderate to severe knee osteoarthritis, have completed a follow-up period of at least three months, the trial's primary timepoint for measurement of key endpoints.

Enlivex Therapeutics Ltd. announced that all 134 patients in the Phase II stage of its randomized, controlled, blinded Phase I/II trial of Allocetra™ for moderate to severe knee osteoarthritis have completed at least three months of follow-up. This three-month mark is the trial’s primary timepoint for measuring key endpoints.

The trial data are now being analyzed and audited. The company aims to publicly release audited topline results on August 18, 2025. These results will cover safety and changes from baseline in knee pain and function compared to placebo.

The multi-center trial began with a Phase I safety run-in to find the best dose and injection schedule. The Phase IIa stage is a double-blind, randomized, placebo-controlled study. It includes an interim, blinded evaluation to spot responder subgroups. Efficacy will be measured at three, six, and twelve months after treatment.

Enrollment Completion - April 21,2025

Phase 1/2

• Drug: Allocetra
• Announced Date: April 21, 2025
• Indication: Sepsis

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.

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.

Dose Update - April 3,2025

Phase 1

• Drug: Allocetra
• Announced Date: April 3, 2025
• Indication: Sepsis

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.

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.

Efficacy Data - March 3,2025

Phase 1/2

• Drug: Allocetra
• Announced Date: March 3, 2025
• Indication: Sepsis

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.

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.

Provided Update - December 11,2024

• Drug: Allocetra
• Announced Date: December 11, 2024
• Indication: Sepsis

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.

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.

Authorization - September 26,2024

Phase 1/2

• Drug: Allocetra
• Announced Date: September 26, 2024
• Indication: Sepsis

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.

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.

Provided Update - September 24,2024

• Drug: Allocetra
• Announced Date: September 24, 2024
• Indication: Sepsis

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.

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.

Authorization - July 23,2024

Phase 1

• Drug: Allocetra
• Announced Date: July 23, 2024
• Indication: Sepsis

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.

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.

Dose Update - June 24,2024

Phase 1/2

• Drug: Allocetra
• Announced Date: June 24, 2024
• Indication: Sepsis

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.

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.

Positive Data - June 17,2024

• Drug: Allocetra
• Announced Date: June 17, 2024
• Indication: Sepsis

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..

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.

Provided Update - June 3,2024

Phase 1/2

• Drug: Allocetra
• Announced Date: June 3, 2024
• Indication: Sepsis

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.

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.