This section highlights FDA-related milestones and regulatory updates for drugs developed by Immunic (IMUX).
Over the past two years, Immunic has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
IMU-838, IMU-838, IMU-838, IMU-856, and Vidofludimus. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
IMU-838 - FDA Regulatory Timeline and Events
IMU-838 is a drug developed by Immunic for the following indication: In Patients with Post COVID Syndrome (RAPID_REVIVE).".
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:
- IMU-838
- Announced Date:
- June 5, 2025
- Indication:
- In Patients with Post COVID Syndrome (RAPID_REVIVE)."
Announcement
Immunic, Inc announced the completion of enrollment for both phase 3 ENSURE trials of lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in patients with relapsing multiple sclerosis and additional phase 2 CALLIPER trial data in patients with progressive multiple sclerosis underlining the recently released positive top-line results.
AI Summary
Immunic, Inc. announced the successful completion of enrollment for two phase 3 ENSURE trials evaluating vidofludimus calcium, a promising treatment for relapsing multiple sclerosis. The study, conducted across more than 100 sites in 15 countries, enrolled over 2,200 patients to compare the drug with a placebo, with primary endpoints focusing on time to first relapse and secondary endpoints including confirmed disability worsening and MRI assessments.
Additionally, recent phase 2 CALLIPER trial data in patients with progressive multiple sclerosis further emphasize vidofludimus calcium’s neuroprotective potential. The data reveal a significant reduction in the time to 24-week confirmed disability worsening compared to placebo across various patient subgroups. These positive initial results strengthen the case for vidofludimus calcium as a novel, dual-action treatment addressing both inflammatory and neurodegenerative aspects of multiple sclerosis.
Read Announcement- Drug:
- IMU-838
- Announced Date:
- February 26, 2025
- Indication:
- In Patients with Post COVID Syndrome (RAPID_REVIVE)."
Announcement
Immunic, Inc. announced the presentation of data on its lead asset, nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in two poster presentations at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2025, taking place from February 27 to March 1, in West Palm Beach, Florida.
AI Summary
Immunic, Inc. announced that it will present new data on its lead asset, vidofludimus calcium—an activator of the neuroprotective transcription factor Nurr1—at the ACTRIMS Forum 2025 in West Palm Beach, Florida, from February 27 to March 1. The company will share findings through two poster presentations. One poster discusses baseline patient characteristics from the phase 2 CALLIPER trial in progressive multiple sclerosis, comparing these with data from other key trials. The CALLIPER trial’s top-line results are expected in April and may provide valuable insights into vidofludimus calcium’s effects on progression independent of relapse activity. The second poster focuses on preclinical data, showing that the drug may reduce neuronal loss and injury by lessening microglial activation. These presentations highlight the potential of vidofludimus calcium as a new treatment option for multiple sclerosis.
Read Announcement- Drug:
- IMU-838
- Announced Date:
- January 7, 2025
- Indication:
- In Patients with Post COVID Syndrome (RAPID_REVIVE)."
Announcement
Immunic, Inc oday highlighted its 2024 accomplishments and upcoming milestones.
AI Summary
Immunic, Inc recently highlighted its 2024 achievements and upcoming milestones, focusing on its promising oral drug, vidofludimus calcium. The company made notable progress with this treatment for multiple sclerosis, reporting that top-line data from the phase 2 CALLIPER trial in progressive MS is expected in April. Preliminary results showed a reduction in neurofilament light chain levels, suggesting potential neuroprotective benefits.
In addition, a positive interim analysis from the twin phase 3 ENSURE trials in relapsing MS was reported. An independent monitoring committee confirmed the trials' continued progress without changes to trial design, with completions projected in 2026. To bolster its efforts, Immunic has also strengthened its management and board with key hires and secured an initial $80 million in funding as part of a planned $240 million private placement.
Read Announcement- Drug:
- IMU-838
- Announced Date:
- September 4, 2024
- Indication:
- In Patients with Post COVID Syndrome (RAPID_REVIVE)."
Announcement
Immunic, Inc announced enrollment of the first patient in an investigator-sponsored phase 2 clinical trial of its lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), entitled, "Randomized Adaptive Assessment of Post COVID Syndrome Treatments_Reducing Inflammatory Activity in Patients with Post COVID Syndrome (RAPID_REVIVE)."
AI Summary
Immunic, Inc. has enrolled the first patient in a phase 2 investigator-sponsored trial, "RAPID_REVIVE," to evaluate its lead drug candidate, vidofludimus calcium (IMU‑838), for treating Post COVID Syndrome (PCS). The study, sponsored by Goethe University Frankfurt and funded by the German government, will test the drug’s ability to reduce inflammation and improve physical function over a treatment period of 56 days. Researchers are particularly interested in vidofludimus calcium’s potential to prevent Epstein‑Barr virus reactivation, which has been linked to the fatigue experienced by many PCS patients. By measuring changes in physical function and fatigue, the trial aims to provide new insights into managing PCS symptoms. The study design is randomized, placebo‑controlled, and double‑blind, ensuring reliable results that may also help guide future approaches for treating similar symptoms in multiple sclerosis patients.
Read Announcement
IMU-838 (CALLIPER) - FDA Regulatory Timeline and Events
IMU-838 (CALLIPER) is a drug developed by Immunic for the following indication: Progressive multiple sclerosis (PMS).
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:
- IMU-838 (CALLIPER)
- Announced Date:
- April 30, 2025
- Indication:
- Progressive multiple sclerosis (PMS)
Announcement
Immunic, Inc announced positive data from its phase 2 CALLIPER trial of nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in patients with progressive multiple sclerosis (PMS).
AI Summary
Immunic, Inc. announced positive results from its phase 2 CALLIPER trial testing vidofludimus calcium (IMU‑838), a first-in-class Nurr1 activator, in patients with progressive multiple sclerosis (PMS). The trial showed that the drug reduced the risk of 24‑week confirmed disability worsening by 20% in the overall population compared to placebo. The effect was even more pronounced in patients with primary progressive multiple sclerosis, where a 30% risk reduction was observed. In patients without gadolinium-enhancing lesions at baseline—who usually do not benefit from anti-inflammatory therapies—a 29% reduction in worsening events was noted. Additionally, vidofludimus calcium reduced thalamic brain volume loss by 20%, supporting its potential neuroprotective benefits. The safety and tolerability profile was favorable with no new safety signals identified, marking an important step toward a future phase 3 trial.
Read Announcement
IMU-838 (EMPhASIS) - FDA Regulatory Timeline and Events
IMU-838 (EMPhASIS) is a drug developed by Immunic for the following indication: Relapsing-remitting multiple sclerosis.
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:
- IMU-838 (EMPhASIS)
- Announced Date:
- June 24, 2025
- Indication:
- Relapsing-remitting multiple sclerosis
Announcement
Immunic, Inc. reported new long-term open-label extension (OLE) data from its phase 2 EMPhASIS trial of lead asset, orally available nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in patients with relapsing-remitting multiple sclerosis (RRMS).
AI Summary
Immunic, Inc. has shared new long-term data from its phase 2 EMPhASIS trial of vidofludimus calcium, an orally available Nurr1 activator, for treating relapsing-remitting multiple sclerosis (RRMS). In this open-label extension study, patients were monitored for up to 5.5 years. At Week 144, 92.3% of patients remained free of 12-week confirmed disability worsening (CDW), while 92.7% stayed free of 24-week CDW. These positive numbers suggest that vidofludimus calcium may help delay the progression of disability in RRMS patients, potentially preserving neurological function and independence over the long term. The study also highlighted a favorable safety and tolerability profile with low rates of treatment-emergent and serious adverse events, and no new safety concerns were observed during the treatment period.
Read Announcement
IMU-856 - FDA Regulatory Timeline and Events
IMU-856 is a drug developed by Immunic for the following indication: Celiac disease.
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:
- IMU-856
- Announced Date:
- February 20, 2025
- Indication:
- Celiac disease
Announcement
Immunic, Inc announced that IMU-856, an orally available and systemically acting small molecule modulator that targets SIRT6 (Sirtuin 6), demonstrated a dose-dependent increase of endogenous glucagon-like peptide-1 (GLP-1) levels in a post hoc analysis of patients from its phase 1b clinical trial in celiac disease.
AI Summary
Immunic, Inc. announced promising findings for IMU-856, an orally available small molecule that targets SIRT6. In a post hoc analysis of its phase 1b clinical trial in celiac disease, the drug showed a dose-dependent increase in endogenous glucagon-like peptide-1 (GLP-1) levels. GLP-1 is a naturally occurring hormone released in the gut that helps regulate blood sugar and satiety. The trial results revealed that higher doses of IMU-856 led to significant increases in GLP-1 compared to placebo, suggesting that the drug can mimic the natural rise in this hormone after a meal. In addition to the clinical data, preclinical studies demonstrated that IMU-856 reduced body weight gain and food consumption in a dose-related manner. These results indicate the potential for IMU-856 as an oral option for weight management, warranting further clinical testing.
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Vidofludimus - FDA Regulatory Timeline and Events
Vidofludimus is a drug developed by Immunic for the following indication: For patients with multiple sclerosis and other chronic inflammatory and autoimmune diseases.
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:
- Vidofludimus
- Announced Date:
- September 18, 2024
- Indication:
- For patients with multiple sclerosis and other chronic inflammatory and autoimmune diseases.
Announcement
Immunic, Inc. announced the presentation of key data at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), highlighting Immunic's lead asset, nuclear receptor related 1 (Nurr1) activator, vidofludimus calcium's (IMU-838) therapeutic potential in multiple sclerosis (MS).
AI Summary
Immunic, Inc. announced it will present key data at the upcoming 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen. The company is highlighting its lead asset, vidofludimus calcium (IMU-838), a small molecule designed to activate the neuroprotective transcription factor Nurr1 while also inhibiting dihydroorotate dehydrogenase. This dual mechanism may offer both neuroprotective and anti-inflammatory benefits for MS patients.
Data from the interim analysis of the phase 2 CALLIPER trial showed that vidofludimus calcium consistently reduced serum neurofilament light chain levels compared to placebo across various progressive MS subtypes. In addition, preclinical studies demonstrated that the drug improves neuronal survival and reduces the development of harmful T helper cells. These findings suggest that vidofludimus calcium could become a promising new treatment option for multiple sclerosis.
Read Announcement- Drug:
- Vidofludimus
- Announced Date:
- April 30, 2024
- Indication:
- For patients with multiple sclerosis and other chronic inflammatory and autoimmune diseases.
Announcement
Immunic, Inc. announced that data from its phase 2 EMPhASIS trial of lead asset, vidofludimus calcium (IMU-838), in patients with relapsing-remitting multiple sclerosis (RRMS) has been published online on April 25, 2024 in Neurology® Neuroimmunology & Neuroinflammation, an official journal of the American Academy of Neurology.
AI Summary
Immunic, Inc. announced that data from its phase 2 EMPhASIS trial of vidofludimus calcium (IMU-838) in patients with relapsing-remitting multiple sclerosis (RRMS) was published online on April 25, 2024, in Neurology® Neuroimmunology & Neuroinflammation, the official journal of the American Academy of Neurology. The study, led by Dr. Robert J. Fox, explored a dose-response relationship by testing different doses of the drug. Results showed that daily doses of 30 mg and 45 mg significantly suppressed the development of gadolinium-enhancing lesions by 78% and 74%, respectively, compared to placebo at 24 weeks. The trial also observed improvements in serum neurofilament light chain levels, suggesting the drug may help protect against neuronal damage. These findings underline the combined neuroprotective and anti-inflammatory effects of vidofludimus calcium, supporting its further development for RRMS treatment.
Read Announcement
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