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Clofazimine

  • Prescription medicine
  • Varies by country
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Clofazimine does in the body

Lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum

4)] .

What happened in people

RNAWiki has not yet published a reviewed conclusion for this use.

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. It is a prescription or clinician-administered medicine where it is approved.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · D959AE5USF · read 2026-08-29

  • Its recorded molecular formula is C27H22C, weighing 473.4 g/mol.

    US prescribing information · 2e07448f-f888-4747-80ab-570c1b621250 · read 2026-08-30

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 28 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Biomarker

A biomarker is a number from a test that stands in for something about health.

A picture of it, and where the picture fails

A biomarker is like a fuel gauge.

Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.

What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.

A measurable indicator used as a substitute for a clinical outcome of interest.

Placebo

A placebo is a dummy treatment given so the real one can be compared with it.

A picture of it, and where the picture fails

A placebo is like a blank control in an experiment.

Where that stops being true. A blank does nothing. People given a placebo often do get better.

What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.

An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.

Comparator

A comparator is whatever the treatment was measured against.

A picture of it, and where the picture fails

It is like the other runner in a race.

Where that stops being true. A race has one winner. A study can show both arms improved.

What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.

The control condition against which the experimental intervention is assessed.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

a favorable outcome at the end of study

The study did not show it

Who was studied
NCT05081401
How many people
1050
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Relapse

The study did not show it

Who was studied
NCT00669643
How many people
859
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Week 73 Efficacy

The study did not show it

Who was studied
NCT02754765
How many people
754
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Unsatisfactory clinical outcome at week 96 after randomisation

The study did not show it

Who was studied
NCT03474198
How many people
675
Study design
Phase 2/Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

STREAM Stage 2 Primary Outcome Measure (the Proportion of Patients With a Favourable Outcome at Week 76)

The study did not show it

Who was studied
NCT02409290
How many people
588
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Stage 1:Percentage of patients with culture conversion in liquid media at 8 weeks post randomisation.

The study did not show it

Who was studied
NCT02589782
How many people
552
Study design
Phase 2/Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Oral

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • LAMPRENE is an antimycobacterial indicated for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum. ( 1.1 ) To prevent the development of drug-resistance, LAMPRENE should be used only as a part of combination therapy for initial treatment of lepromatous leprosy.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “Safety and effectiveness of LAMPRENE in pediatric patients have not been established.”

    US prescribing information · 2e07448f-f888-4747-80ab-570c1b621250 · read 2026-08-30

  • On older people, the label states: “Clinical studies of LAMPRENE did not include sufficient numbers of subjects aged 65 and older to determine whether they respond differently from younger subjects.”

    US prescribing information · 2e07448f-f888-4747-80ab-570c1b621250 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary There are no data with LAMPRENE use in pregnant women to inform associated risk.”

    US prescribing information · 2e07448f-f888-4747-80ab-570c1b621250 · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary LAMPRENE is excreted in human milk.”

    US prescribing information · 2e07448f-f888-4747-80ab-570c1b621250 · read 2026-08-30

  • On people with reduced liver function, the label states: “Avoid LAMPRENE in patients with hepatic impairment (Child-Pugh Class A, B, and C) unless the benefit outweighs the risk.”

    US prescribing information · 2e07448f-f888-4747-80ab-570c1b621250 · read 2026-08-30

  • On people with reduced kidney function, the label states: “No LAMPRENE dosage adjustments are recommended in patients with mild to moderate renal impairment.”

    US prescribing information · 2e07448f-f888-4747-80ab-570c1b621250 · read 2026-08-30

Where the result stopped carrying

  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (11)
It was studied for a different goal
The studies measured something else entirely. Nothing in this record points to this reason.
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Varies by country

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Oral

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. It is a prescription or clinician-administered medicine where it is approved.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

A register records the withdrawal of an approval.

No source is stored against this line.

What is in the pack

Sold as capsule, capsule, liquid filled, given by the oral route.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeNothing found in the sources checked

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Oral

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 4 products list this as an active ingredient in the United States drug directory. 4 of them contain it and nothing else.

    FDA National Drug Code directory · 46016-2030 · read 2026-08-29

  • They are sold as capsule, liquid filled and powder, taken oral.

    FDA National Drug Code directory · 46016-2030 · read 2026-08-29

  • The regulator's established pharmacologic class for it is antimycobacterial [epc].

    FDA National Drug Code directory · 46016-2030 · read 2026-08-29

  • 1 published label names it as an active ingredient. 1 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 2e07448f-f888-4747-80ab-570c1b621250 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 2e07448f-f888-4747-80ab-570c1b621250 · read 2026-08-29

  • Lamprene is oral at 3 DOSAGE FORMS AND STRENGTHS Capsules: 50 mg, brown opaque spherical soft gelatin capsule., recorded as fda label in effect 2026-08-17 in the United States.

    US prescribing information · 2e07448f-f888-4747-80ab-570c1b621250 · read 2026-08-30

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine, withdrawn medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Clofazimine studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Clofazimine are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Where else this substance is registered

FDA substance identifier (UNII)
D959AE5USF
RxNorm concept
197521

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    A register records the withdrawal of an approval.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 1 approved application covers products containing this substance. The earliest was NDA019500, approved 19861215 to NOVARTIS.

    Drugs@FDA application register · NDA019500 · read 2026-08-29

  • Marketing status on the register: discontinued.

    Drugs@FDA application register · NDA019500 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19861215.

    FDA National Drug Code directory · 46016-2030 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

9 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • What was measured, goal by goal — found nothing in the sources checked.
  • How close this is to real life — found nothing in the sources checked.
  • The path through the body — found nothing in the sources checked.
  • Felt, measured, or meaningful — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (10)

On the Clofazimine label: indicated for what?


"LAMPRENE is an antimycobacterial indicated for the treatment of lepromatous leprosy, including dapsone-resistant lepromatous leprosy and lepromatous leprosy complicated by erythema nodosum leprosum. ( 1.1 ) To prevent the development of drug-resistance, LAMPRENE should be used only as a part of combination therapy for…": indications and usage on Clofazimine's label. DailyMed label · 2e07448f-f888-4747-80ab-570c1b621250 · 2026-08-17

36 registered trials of Clofazimine — at which phases?


Registered studies posting no result
31 of 36

36 registered studies of Clofazimine: 16 phase2, 12 phase3, 7 na, 3 na or unstated, 2 phase4, 1 phase1. CLINICALTRIALS_SNAPSHOT · 2026-09-01

148 with a PubMed record

Show the evidence
  • phase2
    16
  • phase3
    12
  • na
    7
  • na or unstated
    3
  • phase4
    2
  • phase1
    1
7 more recorded rows
  • completed
    18
  • active not recruiting
    5
  • recruiting
    4
  • not yet recruiting
    3
  • unknown
    3
  • terminated
    2
  • enrolling by invitation
    1

recorded 2026-09-01 · last checked 2026-09-04

2 of Clofazimine's trials stopped: futility/efficacy, accrual/recruitment?


futility/efficacy (1) and accrual/recruitment (1): Clofazimine's stop wording, clustered. CLINICALTRIALS_SNAPSHOT · 2026-09-01

"Insufficient accrual rate"; 2 of 36 registered studies

Show the evidence

Trial

  • NCT03341767
    terminated; "Insufficient accrual rate"
  • NCT04311502
    terminated; "Accrual was permanently closed due to futility in the experimental arm on June 22, 2023. Follow-up in the experimental arm was extended to 117 weeks."

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Clofazimine used Clofazimine 100 MG Oral Capsule — over how long?


Human studies of Clofazimine used "Clofazimine 100 MG Oral Capsule". ClinicalTrials.gov · 2026-09-01

4 recorded entries; human; also "Clofazimine 100 MG", "Clofazimine 300 mg", "Clofazimine 100 mg"

Show the evidence

human

  • NCT03896685
    Clofazimine 100 MG Oral Capsule
  • NCT04311502
    Clofazimine 100 MG
  • NCT05007821
    Clofazimine 300 mg
  • NCT05007821
    Clofazimine 100 mg

recorded 2026-09-01 · last checked 2026-09-04

Clofazimine's half-life is 25 days — which schedules were studied?


25 days, the half-life Clofazimine's label states: "Elimination The mean elimination half-life of clofazimine is approximately 25 days (range 6.5 to 160 days) following repeated oral doses of 50 or 100 mg LAMPRENE in leprosy patients." DailyMed label · 2e07448f-f888-4747-80ab-570c1b621250 · 2026-08-17

tmax 12 hours.

Show the evidence
  • half life pharmacokinetics
    25 days; Elimination The mean elimination half-life of clofazimine is approximately 25 days (range 6.5 to 160 days) following repeated oral doses of 50 or 100 mg LAMPRENE in leprosy patients.
  • tmax pharmacokinetics
    12 hours; Effect of Food Time to reach peak plasma concentration (median T max ) of clofazimine decreases from 12 hours to 8 hours under fed conditions relative to the fasted state.
  • metabolism pharmacokinetics
    Metabolism Information on the metabolism of clofazimine is limited.

recorded 2026-08-17 · last checked 2026-09-04

Which 13 trials of Clofazimine posted no result?


Posted no result
13 of 13 completed trials
Registrations
NCT00000641, NCT00002331, NCT00001047, NCT00000796, NCT01290744 and NCT03474198, and 7 more
Completion dates
oldest 1994-12; newest 2024-06-22
Show the evidence

Trial

  • NCT00000641
    1994-12
  • NCT00002331
    1995-03
  • NCT00001047
    1996-08
  • NCT00000796
    1998-10
  • NCT01290744
    2015-03
  • NCT03474198
    2022-01-20
7 further recorded trials
  • NCT03942354
    2022-05-10
  • NCT02589782
    2022-08-05
  • NCT04207112
    2022-08-25
  • NCT02754765
    2023-06
  • NCT05294146
    2023-08-08
  • NCT04062201
    2024-04-15
  • NCT04717908
    2024-06-22

At the median, Clofazimine's trials enrolled 162 people — anything larger?


Median enrolment
162
Largest enrolment
1000
Registered trials counted
34

What do 1130 spontaneous reports say about Clofazimine — and not say?


These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Clofazimine appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1130 reaction mentions were counted: electrocardiogram qt prolonged 259; vomiting 164; nausea 150; anaemia 134. FAERS via Open Targets · CHEMBL1292 · 2026-06-24

Show the evidence
  • electrocardiogram qt prolonged
    259
  • vomiting
    164
  • nausea
    150
  • anaemia
    134
  • neuropathy peripheral
    99
  • hepatotoxicity
    91
4 more recorded rows
  • cough
    64
  • decreased appetite
    64
  • drug resistance
    55
  • type 2 lepra reaction
    50

recorded 2026-06-24 · last checked 2026-09-04

Which 10 reactions does Clofazimine's label not list?


anaemia, cough and decreased appetite and 7 more reported for Clofazimine, absent from its label. FAERS via Open Targets · CHEMBL1292 · 2026-06-24

2 label terms; 10 reported and unlisted; 2e07448f-f888-4747-80ab-570c1b621250

Show the evidence
  • anaemia
    count not stated
  • cough
    count not stated
  • decreased appetite
    count not stated
  • drug resistance
    count not stated
  • electrocardiogram qt prolonged
    count not stated
  • hepatotoxicity
    count not stated
4 more recorded rows
  • nausea
    count not stated
  • neuropathy peripheral
    count not stated
  • type 2 lepra reaction
    count not stated
  • vomiting
    count not stated

recorded 2026-06-24 · last checked 2026-09-04

Clofazimine and CYP3A4, CYP2C8 and CYP2D6: shared by which compounds?


CYP3A4, CYP2C8 and CYP2D6 appear in Clofazimine's recorded interaction sentences, 4 in all. DailyMed label · 2e07448f-f888-4747-80ab-570c1b621250 · 2026-08-17

CYP2C8, CYP2D6, CYP3A, CYP3A4, CYP3A4; 5 shared nodes; drug_interactions, pharmacokinetics, clinical_pharmacology

Show the evidence

Interaction statement

  • drug_interactions
    Substrates of CYP3A4/5: Monitor for toxicities when used concomitantly with LAMPRENE.
  • drug_interactions
    7.1 Effect of LAMPRENE on Substrates of CYP3A Concomitant use of LAMPRENE may increase concentrations of drugs that are substrates of CYP3A4/5 [see Clinical Pharmacology (12.3)] which may increase the risk of toxicity of these drugs.
  • pharmacokinetics
    In Vitro Studies Clofazimine inhibits the metabolism of CYP2C8, CYP2D6, CYP3A4/5 drug substrates.
  • clinical_pharmacology
    In Vitro Studies Clofazimine inhibits the metabolism of CYP2C8, CYP2D6, CYP3A4/5 drug substrates.
  • CYP2C8
    FINGOLIMOD LAURYL SULFATE, TAFAMIDIS MEGLUMINE, Arimoclomol, Golodirsen, Naldemedine, Methylnaltrexone, Lapatinib, Tivozanib
  • CYP2D6
    FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Rasagiline, Sofpironium, Fluoxetine
  • CYP3A
    FINGOLIMOD LAURYL SULFATE, Darunavir Propylene Glycolate, Vincristine, Naldemedine, Pemetrexed, Eravacycline, Rasburicase, Repotrectinib

CYP3A4

  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium
  • FINGOLIMOD LAURYL SULFATE, ERYTHROMYCIN LACTOBIONATE, FOSAPREPITANT DIMEGLUMINE, TAFAMIDIS MEGLUMINE, Arimoclomol, Beclometasone, Rasagiline, Sofpironium

recorded 2026-08-17 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1292
CAS number
2030-63-9
RxCUI
2592
InChIKey
WDQPAMHFFCXSNU-BGABXYSRSA-N
Also called
Chlofazimine, Clofazimina, Clofaziminum, Colfazimine, cfz, 3-(P-CHLOROANILINO)-10-(P-CHLOROPHENYL)-2,10-DIHYDRO-2-(ISOPROPYLIMINO)PHENAZINE, CLOFAZIMINUM [WHO-IP LATIN], COLFAZIMINE [VANDF], Clofazimine [EP MONOGRAPH], Clofazimine [JAN], Clofazimine [MART.], Clofazimine [MI]
Development code
G 30320, G30320, NSC-141046
Trade name
Lamprene
Sources (6)

Sources

ChEMBL 37 — CC BY-SA 3.0 Unported · ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Open Targets 26.06 — CC0 · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 4 required field(s) not terminal: Why people use it, Best-supported result, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 6 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

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