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New pill aims to ease sickle cell anemia without pain crises

NCT ID NCT07282210

Disease control Sponsor: Biossil Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Updated 2 times

Summary

This study tests a drug called SIL-8301 (senicapoc) in 105 adults with sickle cell disease who have low hemoglobin but few pain crises. Participants take the drug or a placebo daily for 24 weeks, along with their usual hydroxyurea. The main goal is to see if the drug raises hemoglobin levels by at least 1 g/dL.

What this could mean

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

Active substance
Senicapoc (SIL-8301), a drug taken as tablets
What this could lead to
If it works, this could offer a new daily pill to help manage sickle cell disease by raising hemoglobin levels and reducing complications.
What could go wrong
This is an early Phase 2 trial with only 105 people, so results may not apply to all patients. The drug may not work better than placebo, and side effects are still being studied.

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 105 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

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

16 to 35 years

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: * Documented diagnosis of sickle cell disease * 16-35 years of age * Hb ≤ 9.0 g/dL * History of no more than 1 acute SCD-related painful crises requiring a visit to a medical facility per year within the preceding 2 years * History of at least one hemolytic complication * Current treatment with hydroxyurea Exclusion Criteria: * Receipt of senicapoc in a previous investigational study * Current Red Blood Cell (RBC) transfusion or exchange transfusion program * History of pulmonary hypertension * Active cardiovascular, neurologic, endocrine, hepatic, or renal disorders * Diagnosis of cancer (except non-melanoma skin cancer in situ, cervical cancer in situ, or breast cancer in situ) within the last 5 years * History of liver disease

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Conditions

The condition(s) this trial relates to.

anemia Congenital, Hereditary, and Neonatal Diseases and Abnormalities familial hemolytic anemia hematologic disorder Hemic and Lymphatic Diseases hemolytic anemia hereditary disease inherited hemoglobinopathy sickle cell disease

As listed by the trial registrant

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

Sickle cell anaemia Sickle cell anemia Sickle cell disease

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

    4 sites. 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

  • Centre Hospitalier de l'Université de Montréal (CHUM)

    NOT_YET_RECRUITING

    Montreal, Quebec, Canada

  • McGill University Health Centre

    NOT_YET_RECRUITING

    Montreal, Quebec, Canada

  • The Hospital for Sick Children

    RECRUITING

    Toronto, Ontario, Canada

  • University Health Network, Toronto General Hospital

    NOT_YET_RECRUITING

    Toronto, Ontario, Canada

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