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Ribociclib clinical trials

Also written LEE011 and Kisqali.

studies test it
122
open now
21
in phase 3
19
first study started
2010
ClinicalTrials.gov finds 252 studies for ribociclib. How that becomes 122 here

Every study that search finds has been read, to see whether and how it gives ribociclib. ClinicalTrials.gov counts as of Nov 13, 2026. How drug pages count

  1. 252Found by its intervention search · See all 252 hereIt also reads titles, arm labels, keywords and descriptions, and counts the drug’s other names. Of these, 200 name it in an intervention entry. The counts it shows beside each synonym overlap: a study writing two names counts under both.
  2. −1
    Mention it without giving it — earlier treatment, a protocol code, a title naming another drug
  3. 251Give ribociclib to participants
  4. −46Observe patients on it, or give it outside a trial
  5. −10Compare another treatment with it
  6. −73Give it beside what is tested
  7. 122Test it: the count on this site

Get an email when these change. Save the ribociclib studies recruiting or about to start — once a week, free: studies that open, close, add sites or post results.

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Example · made-up studies

Breast cancer · Recruiting: 2 came in, 3 changed

What changed in your saved searches, Oct 31 – Nov 6:

A study of drug A after surgery for early breast cancer

Came in · now Recruiting

Drug B with hormone therapy in advanced breast cancer

Changed

· Sites: 4 added, including Seoul and Busan

· Enrollment: 300 → 450 participants

Exercise during chemotherapy

Now Active, not recruiting

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Approvals

The first approval found in each region, with its record

United States
13 Mar 2017 · KISQALI · NDA 209092 (FDA, Drugs@FDA)
European Union
22 Aug 2017 · Kisqali · EMEA/H/C/004213 (EMA)

From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out

How studies write it

Studies that test it under each name

Name

Ribociclib
71
Ribociclib 200Mg Oral Tablet
2
Ribociclib (LEE011)
2
Ribociclib Oral Tablet
2
Ribociclib 600mg
2

Brand

Kisqali
26

Development codes

LEE011
65

Studies by the year they started

122 studies that test it; most in 2016 (20)

Studies that test ribociclib, by start year
YearStudies
20101
20121
20139
20146
201513
201620
201712
201813
20199
20214
202210
20233
202412
20253
20266

By phase

A phase 1/2 study counts in both.

Early Phase 1
4
Phase 1
46
Phase 2
59
Phase 3
19
Phase 4
6
No phase
4

What it is tested for

Each study’s main condition, where its own words name it, so a study counts once.

Breast Neoplasms
53
Glioblastoma
4
Melanoma
4
Neoplasms
4
Liposarcoma
3
Neuroblastoma
3
Diffuse Intrinsic Pontine Glioma
2
Prostatic Neoplasms
2
Glioma
2
Lymphoma
2
Squamous Cell Carcinoma of Head and Neck
2
Endometrial Neoplasms
1

Who runs them

Industry 41 · Other 81

Novartis Pharmaceuticals (34) · SOLTI Breast Cancer Research Group (3) · Pfizer (3) · M.D. Anderson Cancer Center (2) · University of Michigan Rogel Cancer Center (2) · Borstkanker Onderzoek Groep (2) · Dana-Farber Cancer Institute (2) · Fox Chase Cancer Center (2)

Often tested with

Tested in the same studies.

Palbociclib (15) · Everolimus (7) · Letrozole (6) · Encorafenib (5) · Alpelisib (4) · Trametinib (4) · Abemaciclib (4) · Anastrozole (4)

Related medicines

As reviewed, each with the page that says it.

Coming up

From the study records. Dates are the sponsors’ own estimates and often move.

Tested against it · 3 phase 3 studies under way

Ribociclib is the comparator. A study of two new drugs counts under both.

New treatments tested with it · 8 most studied

New when their studies opened, with ribociclib beside them; studies of each.

Reaching primary completion within a year · 10, 1 in phase 3

Studies that test ribociclib, phase 3 first.

Studies

Open first, then newest update. How each study uses ribociclib has had a first review, but it may not be perfect: check the study record before relying on it for anything important, and report a problem from its row. Some give it without naming it in an intervention entry: those were found by reading the record.

Testing it · 122

See all 122 studies that test ribociclib →

Behind its US label · 5 — the studies the FDA label of KISQALI describes

From the Clinical Studies section of KISQALI (2026-07), as openFDA has it. A study the site does not hold is left out.

Tested on its own · 29 — no other medicine in its arm

Showing 20 of 29. See all 29 →

Tested with established drugs · 36 — they are given beside it

Showing 20 of 36. See all 36 →

Tested in a combination · 57 — another drug in the study is under test too

Showing 20 of 57. See all 57 →

Beside an established treatment under test · 14 — an approved drug, surgery or radiation is what the study tests

Tested with ribociclib: Surgery or a procedure 2 · Radiation 2 · exemestane 1 · Anastrozole 1 · capivasertib 1 · AZD9833 1 · inavolisib 1 · binimetinib 1

Beside a new treatment under test · 44 — a new drug, cell therapy or vaccine is what the study tests

New treatments tested with ribociclib: AZD9833 5 · giredestrant 3 · atirmociclib 2 · capivasertib 2 · Iparomlimab/Tuvonralimab 2 · ipatasertib 2 · inavolisib 2 · STX-478 2

Showing 20 of 44. See all 44 →

Beside supportive care · 11 — a supportive treatment or test is studied
One option of several · 4 — a test or a strategy chooses among drugs
As the comparator · 10 — what is tested is compared with ribociclib
Observed · 46 — patients on it are followed, or it is given outside a trial

Showing 20 of 46. See all 46 →

Codes

What other systems call ribociclib · ClinicalTrials.gg INT000035

  • MeSH (NLM) C000589651ribociclibConfirmed ClinicalTrials.gov, NLM
  • UNII (FDA) TK8ERE8P56RIBOCICLIBConfirmed FDA, NLM, Wikidata
  • RxNorm 1873916Confirmed FDA, Wikidata
  • Wikidata Q27088552ribociclibConfirmed FDA, NLM, Wikidata
  • NCI Thesaurus C95701RibociclibConfirmed FDA, Wikidata
  • DrugBank DB11730One source Wikidata

Also registered as ribociclib succinate (UNII BG7HLX2919 · RxNorm 1873978).

“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.

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