Last reviewed 2026-05-22 · How we verify

Cladribine Pill

Haukeland University Hospital · Phase 3 active Small molecule Under review Quality 0/100

Cladribine Pill is a Purine nucleoside analog Small molecule drug developed by Haukeland University Hospital. It is currently in Phase 3 development for Multiple sclerosis (relapsing-remitting), Hairy cell leukemia, Chronic lymphocytic leukemia. Also known as: Mavenclad.

Cladribine is a purine nucleoside analog that inhibits ribonucleotide reductase and gets incorporated into DNA, leading to selective depletion of lymphocytes.

The Cladribine Pill is a small molecule that inhibits DNA, classified as a DNA inhibitor. It is being studied as a treatment for Multiple Sclerosis, with clinical trials comparing it to other treatments such as Alemtuzumab and autologous hematopoietic stem cell transplantation.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Cladribine Pill
Also known as	Mavenclad
Sponsor	Haukeland University Hospital
Drug class	Purine nucleoside analog
Target	Ribonucleotide reductase; DNA incorporation
Modality	Small molecule
Therapeutic area	Immunology; Oncology
Phase	Phase 3

Mechanism of action

Cladribine is a deoxyadenosine analog that is phosphorylated intracellularly and incorporated into DNA, causing strand breaks and apoptosis. It preferentially affects lymphocytes due to their high deoxycytidine kinase activity and low 5'-nucleotidase activity, making it useful in lymphoproliferative and autoimmune disorders.

Approved indications

Multiple sclerosis (relapsing-remitting)
Hairy cell leukemia
Chronic lymphocytic leukemia

Common side effects

Lymphopenia
Anemia
Thrombocytopenia
Infection
Nausea
Fatigue

Key clinical trials

Randomized Autologous heMatopoietic Stem Cell Transplantation Versus Alemtuzumab, Cladribine or Ocrelizumab for RRMS (RAM-MS) (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Cladribine Pill CI brief — competitive landscape report
Cladribine Pill updates RSS · CI watch RSS
Haukeland University Hospital portfolio CI

Frequently asked questions about Cladribine Pill

What is Cladribine Pill?

Cladribine Pill is a Purine nucleoside analog drug developed by Haukeland University Hospital, indicated for Multiple sclerosis (relapsing-remitting), Hairy cell leukemia, Chronic lymphocytic leukemia.

How does Cladribine Pill work?

Cladribine is a purine nucleoside analog that inhibits ribonucleotide reductase and gets incorporated into DNA, leading to selective depletion of lymphocytes.

What is Cladribine Pill used for?

Cladribine Pill is indicated for Multiple sclerosis (relapsing-remitting), Hairy cell leukemia, Chronic lymphocytic leukemia.

Who makes Cladribine Pill?

Cladribine Pill is developed by Haukeland University Hospital (see full Haukeland University Hospital pipeline at /company/haukeland-university-hospital).

Is Cladribine Pill also known as anything else?

Cladribine Pill is also known as Mavenclad.

What drug class is Cladribine Pill in?

Cladribine Pill belongs to the Purine nucleoside analog class. See all Purine nucleoside analog drugs at /class/purine-nucleoside-analog.

What development phase is Cladribine Pill in?

Cladribine Pill is in Phase 3.

What are the side effects of Cladribine Pill?

Common side effects of Cladribine Pill include Lymphopenia, Anemia, Thrombocytopenia, Infection, Nausea, Fatigue.

What does Cladribine Pill target?

Cladribine Pill targets Ribonucleotide reductase; DNA incorporation and is a Purine nucleoside analog.

Drug class: All Purine nucleoside analog drugs
Target: All drugs targeting Ribonucleotide reductase; DNA incorporation
Manufacturer: Haukeland University Hospital — full pipeline
Therapeutic area: All drugs in Immunology; Oncology
Indication: Drugs for Multiple sclerosis (relapsing-remitting)
Indication: Drugs for Hairy cell leukemia
Indication: Drugs for Chronic lymphocytic leukemia
Also known as: Mavenclad

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing