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New pill could tame lung inflammation in sarcoidosis

NCT ID NCT06205121

Disease control Sponsor: Molecure S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This Phase 2 trial tests OATD-01, an oral drug that blocks a protein called chitinase-1, in 96 people with active pulmonary sarcoidosis. Participants take the drug or a placebo for 12 weeks to see if it reduces lung inflammation measured by PET scans. The goal is to find a new treatment option for this chronic lung condition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OATD-01 (an oral drug that blocks chitinase-1, a protein involved in inflammation)
What this could lead to
If successful, this could point toward a new treatment option for people with active pulmonary sarcoidosis, potentially reducing lung inflammation without needing long-term steroids.
What could go wrong
This is an early Phase 2 trial with only 96 people, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.
Why investors are watching

Molecure is a very small publicly traded company, and this Phase 2 trial tests its lead drug, OATD-01, in 96 patients with active pulmonary sarcoidosis, a lung disease with no approved targeted treatment. The result matters because a positive readout would validate the drug's mechanism and give the company its first major clinical proof, while a negative result would leave it without a clear path forward.

If it works: A positive result could show that OATD-01 safely improves sarcoidosis symptoms, which might attract a larger partner to fund later-stage development. That outcome would give Molecure a credible asset and a reason to continue investing in the drug.

If it fails: A failed or delayed trial could set the program back years and drain the company's limited resources. Most Phase 2 drugs do not succeed, so investors should expect that outcome as a real possibility.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 96 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male and female subjects with active symptomatic pulmonary sarcoidosis, (definite diagnosis of active pulmonary sarcoidosis per ATS guidelines) * Treatment-naïve or previously treated (no recruitment cap) * Parenchymal pulmonary involvement on \[18F\]FDG PET/CT Exclusion Criteria: * Requirement for immediate start of standard of care therapy for pulmonary sarcoidosis * Active cardiac or neuro- sarcoidosis * History of/active Löfgren syndrome * Clinically significant lung disease other than sarcoidosis (e.g. tuberculosis, asthma, Chronic Obstructive Pulmonary Disease, interstitial lung disease, lung cancer) or any current inflammatory or immunological systemic disease other than sarcoidosis * Potentially effective systemic or inhaled pharmacological (including investigational) therapy for sarcoidosis (whether pulmonary or other disease), with the exception of any of the following: 1. corticosteroids received not later than 3 months prior to enrolment 2. immunosuppressants or anti-Tumor Necrosis Factor (TNF) agents (or other anti-inflammatory/anti-fibrotic treatment) received not later than 4 months prior to enrolment * Systemic treatment indication being an extrapulmonary location of sarcoidosis (e.g., neurological) * Heart conditions: QTcF interval prolongation, cardiac arrhythmia (other than non-sustained supraventricular arrhythmia), heart failure (New York Heart Association class III or IV) and/or known myocardial hypertrophy or Left Ventricle Ejection Fraction \<50% in the cardiac MRI * Known neurosarcoidosis or small fiber neuropathy or medical conditions causing primary ataxia * Lab abnormalities: Abnormal bilirubin, transaminases, alkaline phosphatase (ALP), Creatinine clearance (CrCL) Hypokalemia hypocalcemia (\<2.1 mmol/L), marked fasting hyperglycemia at screening * Uncontrolled diabetes at Screening with plasma glucose exceeding 8.3 mmol/L, or other contraindication to \[18F\]FDG administration and/or PET procedure (including body temperature \>37°C and any metabolic disease affecting the energy metabolism of muscles) as described in the PET protocol * Known positivity for Human Immunodeficiency Virus (HIV 1/2 antibodies), hepatitis B virus (HBV), or hepatitis C virus (HCV), or detected at screening * Severe, uncontrolled systemic disease (e.g., cardiovascular, pulmonary, thyroid, renal or metabolic disease) at Screening, or other condition, which in the opinion of the investigator, would compromise the safety of the subject or the subject's ability to participate in the study * Current smoker of \>5 cigarettes or e-cigarettes per day or user of nicotine-releasing alternatives (patches, chewing gums etc) * Prohibited medications: Current treatment with drug with QT prolongation effect, thiazide diuretics, strong CYP3A4 inhibitors and/or inducers, P-glycoprotein and/or BCRP strong inhibitors, drugs that are sensitive substrates of OCT1, MATE1, MATE2K, OAT3 with a narrow therapeutic index, pirfenidone and nintedanib.

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Conditions

The condition(s) this trial relates to.

pulmonary sarcoidosis sarcoidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary sarcoidosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    21 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Molecure Investigative Site

    WITHDRAWN

    Birmingham, Alabama, 35209, United States

  • Molecure Investigative Site

    WITHDRAWN

    Kansas City, Kansas, 66062, United States

  • Molecure Investigative Site

    RECRUITING

    Baltimore, Maryland, 21224, United States

  • Molecure Investigative Site

    WITHDRAWN

    Rochester, Minnesota, 55905, United States

  • Molecure Investigative Site

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Molecure Investigative Site

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • Molecure Investigative Site

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Molecure Investigative Site

    WITHDRAWN

    Vejle, 7100, Denmark

  • Molecure Investigative Site

    WITHDRAWN

    Bobigny, 93000, France

  • Molecure Investigative Site

    RECRUITING

    Montpellier, 34295, France

  • Molecure Investigative Site

    RECRUITING

    Paris, 75013, France

  • Molecure Investigative Site

    RECRUITING

    Paris, 75015, France

  • Molecure Investigative Site

    RECRUITING

    Essen, 45239, Germany

  • Molecure Investigative Site

    RECRUITING

    Freiburg im Breisgau, 79106, Germany

  • Molecure Investigative Site

    RECRUITING

    Mainz-GE, 55131, Germany

  • Molecure Investigative Site

    WITHDRAWN

    Corfu, 49100, Greece

  • Molecure Investigative Site

    RECRUITING

    Heraklion, 71500, Greece

  • Molecure Investigative Site

    RECRUITING

    Pátrai, 26500, Greece

  • Molecure Investigative Site

    RECRUITING

    Thessaloniki, 57010, Greece

  • Molecure Investigative Site

    RECRUITING

    Nieuwegein, 3435 CM, Netherlands

  • Molecure Investigative Site

    RECRUITING

    Rotterdam, 3015 GD, Netherlands

  • Molecure Investigative Site

    RECRUITING

    Bergen, 5009, Norway

  • Molecure Investigative Site

    RECRUITING

    Oslo, 1478, Norway

  • Molecure Investigative Site

    RECRUITING

    Birmingham, B15 2GW, United Kingdom

  • Molecure Investigative Site

    WITHDRAWN

    Cambridge, CB2 0AY, United Kingdom

  • Molecure Investigative Site

    RECRUITING

    Edinburgh, EH16 4SA, United Kingdom

  • Molecure Investigative Site

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Molecure Investigative Site

    RECRUITING

    London, SW3 6JY, United Kingdom

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