The goal of Part 1 of this clinical research study is to find the highest tolerable dose of cladribine that can be given in combination with low dose cytarabine (LDAC) and venetoclax to patients who have AML.
The goal of Part 2 of this clinical research study is to learn if the dose of cladribine found in Part 1, when combined with LDAC and venetoclax, can help to control the disease.

Start Date01 Dec 2027

Sponsor / Collaborator-

NCT07757672

/ Not yet recruitingPhase 1/2IIT

A Prospective Phase II Clinical Trial of Salvage Chemotherapy With Sonrotoclax, Cladribine, and Standard-dose Cytarabine, Sequentially Followed by Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed/Refractory Acute Myeloid Leukemia

The goal of this clinical trial is to treat adult patients with relapsed/refractory acute myeloid leukemia (AML) using a salvage chemotherapy regimen consisting of Sonrotoclax, cladribine, and standard-dose cytarabine, sequentially followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT). The main questions it aims to answer are:
Does this treatment regimen improve the 2-year overall survival (OS) rate, relapse-free survival (RFS) rate, and cumulative incidence of relapse (CIR) in this patient population?
What is the safety profile of this combination and sequential transplant strategy, particularly regarding treatment-related mortality (TRM) and adverse events?
As this is a single-arm phase II study, there is no comparator group.
Participants will:
Receive salvage chemotherapy with cladribine (5 mg/m² on days 1-5), cytarabine (100 mg/m² twice daily on days 1-5), and Sonrotoclax (escalating doses from 40 mg to 320 mg on days 1-14).
Undergo allogeneic hematopoietic stem cell transplantation as a bridge therapy within 1 to 4 weeks after completing chemotherapy.
Potentially receive Sonrotoclax as maintenance therapy after hematopoietic reconstitution post-transplant, at the investigator's discretion.
Undergo regular follow-up visits for clinical assessments, disease monitoring, and survival evaluation.

Start Date01 Sep 2026

Sponsor / Collaborator-

NCT07517185

/ RecruitingPhase 2

The HIt HArd and hiT Early in Multiple Sclerosis Trial - HiHat Trial A Phase 2 Study of Sequential Treatment With Rituximab and Cladribine for Relapsing-remitting Multiple Sclerosis

The HiHat trial is a Phase 2 study aimed at evaluating the safety and feasibility of sequential treatment with rituximab and cladribine in patients with relapsing-remitting multiple sclerosis (RRMS). The study follows a prospective, open-label, single-arm design, with 60 RRMS patients receiving both treatments in a controlled regimen: two cycles of rituximab (1,000 mg each, biweekly) followed by two cycles of cladribine (30 mg per cycle for three days per cycle) spaced one month apart. Participants are monitored over 24 months through clinical assessments, MRI, and biomarker analyses. The primary objective is to evaluate whether the rate of serious adverse events (SAE) is acceptably low. Secondary objectives include assessing impacts on MRI lesion count, relapse rates, disability progression, quality of life, and safety.

Start Date01 Sep 2026

Sponsor / Collaborator

University of Uppsala

100 Clinical Results associated with Cladribine

100 Translational Medicine associated with Cladribine

100 Patents (Medical) associated with Cladribine

2,901

Literatures (Medical) associated with Cladribine

01 Sep 2026·Multiple Sclerosis and Related Disorders

Modified Delphi consensus on the use of cladribine tablets in relapsing-remitting multiple sclerosis in North-West Africa

Article

Author: Djebari, Fouzia ; Zeineddine, Maya ; Toubal, Nadia ; Tibar, Houyam ; Makhlouf, Karim ; Belahcene, Faouzi ; Yamout, Bassem ; Mhiri, Chokri ; Daoudi, Smail ; Gouider, Riadh ; Taha, Karim

BACKGROUND:

Cladribine tablets are an oral immune reconstitution therapy with demonstrated efficacy and durable disease control in relapsing-remitting multiple sclerosis (RRMS). While global evidence supports their use, region-specific guidance adapted to healthcare variability, access constraints, and real-world practice in North-West Africa (NWA) remains limited.

OBJECTIVES:

To develop expert-based, region-specific consensus recommendations on the optimal use of cladribine tablets in RRMS in the NWA region.

METHODS:

A modified Delphi methodology was conducted during a face-to-face advisory board meeting in May 2025 in Tunisia. Senior neurologists with expertise in multiple sclerosis from across NWA reviewed available evidence, discussed key clinical questions, and voted on consensus statements addressing treatment positioning, early use, switching strategies, long-term management, safety, and special populations. Consensus was predefined as agreement by ≥75% of voting experts.

RESULTS:

All consensus statements met the predefined threshold after discussion and refinement, achieving high to unanimous agreement. Experts endorsed cladribine tablets as a high-efficacy option for treatment-naïve patients with moderate-to-high disease activity and as a switch option following suboptimal response to platform therapies and in selected patients previously treated with high-efficacy therapies. Benefits include early initiation, durable disease control without continuous immunosuppression, and suitability for patients with limited access to hospital-based care. Expert consensus recommendations also addressed long-term management beyond Year 4, retreatment strategies, safety monitoring, pregnancy planning, and use in older patients, recognizing that some areas are supported mainly by emerging real-world evidence and expert clinical experience.

CONCLUSION:

This Delphi consensus provides practical, region-specific guidance to optimize the use of cladribine tablets in RRMS across NWA, aiming to harmonize treatment practices and improve long-term outcomes.

01 Sep 2026·AMERICAN JOURNAL OF HEMATOLOGY

Systemic Mastocytosis in Adults: 2026 Update on Diagnosis, Risk Stratification and Management

Review

Author: Pardanani, Animesh

ABSTRACT:

Overview:

Systemic mastocytosis (SM) results from clonal proliferation of mast cells (MC) in extra‐cutaneous organs.

Diagnosis:

The major criterion is the presence of multifocal MC clusters in the bone marrow and/or extracutaneous organs. Minor diagnostic criteria include elevated serum tryptase level, MC CD25/CD2/CD30 expression, and the presence of activating KIT mutations.

Risk Stratification:

Establishing SM subtype as per the International Consensus Classification/World Health Organization classification systems is an important first step. Patients either have indolent/smoldering SM (ISM/SSM) or advanced SM, including aggressive SM (ASM), SM with associated myeloid neoplasm (SM‐AMN), or mast cell leukemia. Identification of poor‐risk mutations (i.e., ASXL1, RUNX1, SRSF2, NRAS ) further refines the risk stratification. Several risk models are available to help assign prognosis in SM patients.

Management:

Treatment goals for ISM patients are primarily directed towards anaphylaxis prevention/symptom control/osteoporosis treatment. Patients with advanced SM frequently need MC cytoreductive therapy to reverse disease‐related organ dysfunction. Tyrosine kinase inhibitors (TKI) (midostaurin, avapritinib) have changed the treatment landscape in SM. While deep biochemical, histological, and molecular responses have been documented with avapritinib treatment, its efficacy as monotherapy against a multimutated AMN disease component in SM‐AMN patients remains unclear. Cladribine continues to have a role for MC debulking, whereas interferon‐α has a diminishing role in the TKI era. Treatment of SM‐AMN primarily targets the AMN component, particularly if an aggressive disease such as acute leukemia is present. Allogeneic stem cell transplant has a role in such patients. Imatinib has a therapeutic role only in the rare patient with an imatinib‐sensitive KIT mutation.

01 Sep 2026·Neurology-Neuroimmunology & Neuroinflammation

The Art of Sequencing Disease-Modifying Therapies in Multiple Sclerosis

Review

Author: Bsteh, Gabriel ; Dersch, Rick S. ; Wiendl, Heinz ; Pfeuffer, Steffen

Over the past decade, therapeutic paradigms in multiple sclerosis have shifted toward a "hit-hard-and-early" approach to suppress inflammatory activity and delay progression. However, adverse events, safety concerns, aging, comorbidities, and life circumstances frequently necessitate treatment transitions during the patient journey. Sequencing decisions generally arise from 3 scenarios: insufficient efficacy, tolerability or safety issues, and conceptual considerations such as family planning or exit strategies for discontinuation. Discontinuation or de-escalation of therapy is associated with a significant risk of disease reactivation, particularly after lymphocyte-trafficking inhibitors, underscoring the importance of proactive transition planning to maintain disease control. Evidence suggests that treatment-specific immunologic effects strongly influence optimal sequencing. This narrative review synthesizes mechanistic insights and real-world clinical evidence to guide sequencing strategies for disease-modifying therapies (DMTs) in multiple sclerosis (MS), an increasingly relevant challenge in the era of early high-efficacy treatment. Following natalizumab, anti-CD20 monoclonal antibodies demonstrate superior control of relapse and MRI activity compared with sphingosine-1-phosphate receptor modulators (S1PRMs). Short transition intervals (<30 days) may minimize risk of rebound activity. After S1PRMs, rapid initiation of anti-CD20 therapies or cladribine seems effective, whereas prolonged washout periods increase relapse risk. Anti-CD20 therapies provide sustained suppression of inflammatory activity but are associated with long-term risks, including hypogammaglobulinemia and infections; cladribine may represent a viable exit strategy by enabling durable immune reconstitution. Platform therapies permit straightforward escalation without major rebound concerns, although lymphopenia must be considered when switching from dimethyl fumarate. Emerging Bruton tyrosine kinase inhibitors may further reshape sequencing paradigms, potentially functioning as maintenance therapies targeting compartmentalized inflammation after initial immune-depleting treatment. Future strategies will likely rely on close clinical and biomarker-based monitoring to individualize transitions and identify therapeutic windows. Overall, pragmatic sequencing that anticipates future switches and balances rebound risk against cumulative immunosuppression is essential for optimizing long-term outcomes in MS.

127

News (Medical) associated with Cladribine

01 Sep 2026

·allsci.com

Novartis's remibrutinib beats teriflunomide across Phase III relapsing MS trials

Novartis's remibrutinib has met the primary endpoint in both replicate Phase III trials in relapsing multiple sclerosis (RMS), demonstrating superiority over Sanofi's Aubagio (teriflunomide) in reducing annualized relapse rate (ARR) and on all key secondary endpoints, including MRI lesion burden. Novartis said it plans to submit to health authorities globally. The REMODEL-1 and REMODEL-2 trials each enrolled approximately 1,000 adults with RMS and evidence of recent disease activity, randomizing them 1:1 to remibrutinib 100 mg or teriflunomide in a double-blind, active comparator-controlled design. Both studies met their primary ARR endpoint, and a preplanned combined analysis showed a positive trend on 3-month confirmed disability progression (3mCDP) and nominal significance on 6-month confirmed disability progression (6mCDP). Specific ARR values, hazard ratios, and p-values were not disclosed in the topline release; full data will be presented as a late-breaker at MSToronto2026. The safety profile was consistent with remibrutinib's broader clinical program across more than 4,500 participants, with no liver safety signal and no cases meeting Hy's Law criteria — a point of differentiation from earlier-generation BTK inhibitors that carried hepatotoxicity concerns. Remibrutinib covalently inhibits Bruton's tyrosine kinase (BTK), blocking downstream B-cell receptor signaling and reducing activation of both peripheral B cells and innate immune cells, including CNS-resident microglia — offering a potential way to modulate compartmentalized neuroinflammation that is less directly targeted by peripheral B-cell-depleting antibodies. The RMS treatment landscape is dominated by high-efficacy anti-CD20 agents — Roche's Ocrevus (ocrelizumab) and Novartis's own Kesimpta (ofatumumab) — administered by infusion or injection. The oral high-efficacy segment is less crowded: cladribine requires only short annual courses but operates via immune reconstitution rather than continuous suppression, while sphingosine-1-phosphate receptor modulators such as Johnson & Johnson's Ponvory (ponesimod) — which demonstrated superiority over teriflunomide in the OPTIMUM trial — carry cardiac monitoring requirements. Remibrutinib's oral twice-daily format, absence of required laboratory monitoring in its approved CSU indication, and clean hepatic safety profile across a large development program differentiate it from both classes. The REMODEL trials used teriflunomide as comparator rather than a high-efficacy agent, so the magnitude of remibrutinib's advantage over anti-CD20 therapies remains to be established in direct comparison. During its Q1 2026 earnings call, Novartis framed a positive MS outcome as the single largest potential driver of upside to its guided 5–6% growth trajectory to 2030. The company also has a Phase III trial in secondary progressive MS (REMASTER) recruiting, and a separate study evaluating remibrutinib after switching from Roche's ocrelizumab in RMS patients, which would directly test the anti-CD20 transition scenario. The FDA approved remibrutinib for CSU in September 2025, and the EMA granted approval in April 2026, giving Novartis a commercial infrastructure and regulatory track record on which to build the RMS filing. Access the AllSci platform to explore the science behind the news. Spot something wrong? Report an issue with this article

Phase 3Clinical ResultDrug Approval

26 Aug 2026

·www.biospace.com

BioNxt Advances Cladribine Clinical Program for MS with Completion of the Investigational Medicinal Product Dossier (IMPD) Ahead of Human Clinical Studies

VANCOUVER, BC / ACCESS Newswire / August 26, 2026 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT), a bioscience innovator specializing in advanced drug delivery systems, is pleased to announce the completion of the Investigational Medicinal Product Dossier ("IMPD") for BNT23001, the Company's lead proprietary sublingual cladribine oral dissolvable film (ODF) product candidate for the treatment of relapsing forms of multiple sclerosis (MS). Completion of the IMPD represents a significant regulatory milestone and advances BioNxt's lead development program toward its planned first human bioequivalence study. The IMPD is currently undergoing final technical and regulatory review prior to its planned submission as part of the Company's Clinical Trial Application (CTA) package in Europe. As one of the principal regulatory documents required to support clinical trial authorization, the IMPD consolidates the pharmaceutical, manufacturing, analytical, non-clinical and clinical documentation necessary for regulatory review of an investigational medicinal product. Completion of this comprehensive dossier reflects the successful integration of BioNxt's proprietary formulation development, GMP manufacturing, analytical method development, quality systems and preclinical research into a single regulatory package designed to support regulatory review and the planned initiation of human clinical studies. A Major Regulatory Milestone for BioNxt's Lead Drug Candidate The Investigational Medicinal Product Dossier (IMPD) is among the most comprehensive regulatory submissions prepared during pharmaceutical product development. It provides regulators with detailed information regarding product quality, manufacturing controls, analytical validation, stability, non-clinical evaluation and the proposed clinical study design, serving as a cornerstone of the Clinical Trial Application process in Europe. The IMPD was prepared with the support of BioNxt's pharmaceutical development partners and is currently undergoing final technical review prior to regulatory submission. "Completion of the IMPD marks a significant achievement for BioNxt and reflects the tremendous progress our team and partners have made in advancing BNT23001 toward human clinical evaluation," said Hugh Rogers, Chief Executive Officer of BioNxt Solutions Inc. "Over the past several years, we have systematically advanced every major component of the program-from formulation development and GMP manufacturing to preclinical evaluation and regulatory documentation. With the IMPD now complete and undergoing final review, we are preparing for the next stage of regulatory engagement as we work toward initiating our first human clinical study. This milestone further validates our proprietary oral dissolvable film platform and demonstrates our ability to transform established pharmaceutical compounds into differentiated, patient-centric therapies." Building a Comprehensive Clinical Development Package Completion of the IMPD builds upon a series of important scientific, manufacturing and regulatory achievements, including: Development of BioNxt's proprietary BNT23001 sublingual cladribine oral dissolvable film (ODF); Completion of GMP process development and manufacture of the clinical trial batch; Successful comparative pharmacokinetic studies evaluating systemic exposure of the cladribine ODF formulation in relevant preclinical models; Successful completion of local tolerability studies supporting sublingual administration; Finalization of the clinical protocol for the planned human bioequivalence study; Secured patent protection in Europe and the Eurasian region covering BioNxt's proprietary sublingual cladribine technology. Collectively, these accomplishments demonstrate the maturity of BioNxt's lead development program and provide the scientific, manufacturing and regulatory foundation supporting its planned transition into clinical development. Advancing Toward Human Clinical Studies Following completion of the IMPD and subject to regulatory review and approval, BioNxt intends to submit a Clinical Trial Application (CTA) for a randomized, open-label, crossover bioequivalence study comparing BNT23001 with the reference product, Mavenclad®, in healthy volunteers. The planned study is designed to evaluate pharmacokinetic bioequivalence while assessing the safety and tolerability of BioNxt's proprietary sublingual formulation. Successful completion of the planned study would represent an important clinical and regulatory milestone supporting the continued development of BNT23001 under BioNxt's hybrid regulatory pathway in Europe. Advancing Next-Generation Drug Delivery BioNxt's proprietary oral dissolvable film platform is designed for rapid sublingual administration, providing a needle-free and patient-friendly dosage form that dissolves without water and is intended to facilitate systemic drug exposure through transmucosal absorption. The platform is being developed to improve treatment convenience, particularly for patients experiencing swallowing difficulties, while leveraging an established active pharmaceutical ingredient through an innovative drug delivery system. By combining proprietary formulation technologies with approved pharmaceutical compounds, BioNxt believes its development strategy may enable a more efficient regulatory pathway than the development of entirely new molecular entities, while creating opportunities for differentiated lifecycle management of established therapeutics. BioNxt's proprietary sublingual ODF platform is particularly well suited for neurological indications such as multiple sclerosis, where swallowing difficulties (dysphagia) affect approximately 45% of patients. By eliminating the need to swallow conventional oral tablets with water, the platform is designed to improve convenience, support patient adherence and provide a patient-friendly, needle-free alternative for individuals living with MS. Expanding the Clinical Opportunity BNT23001 is BioNxt's lead neurological development program and is initially being developed for the treatment of relapsing forms of multiple sclerosis. The Company also believes its proprietary cladribine ODF platform has the potential to support future development opportunities in additional autoimmune neurological disorders, including myasthenia gravis, where patient-friendly, needle-free drug delivery may provide meaningful therapeutic and commercial advantages. Beyond BNT23001, BioNxt continues to evaluate opportunities to expand its oral dissolvable film platform across additional therapeutic indications where improved drug delivery may enhance patient experience and support future product development. The Company believes completion of the IMPD further strengthens the clinical and regulatory foundation of its proprietary oral dissolvable film platform and represents another important step in executing its strategy to advance innovative drug delivery technologies through clinical development and potential strategic partnering opportunities. About BNT23001: BioNxt's Proprietary Cladribine ODF Candidate BNT23001 is BioNxt's proprietary sublingual oral dissolvable film formulation of cladribine, developed as a needle-free alternative to conventional oral tablets for the treatment of relapsing forms of multiple sclerosis. The product is designed to deliver cladribine through the oral mucosa using BioNxt's proprietary oral dissolvable film platform with the objective of achieving systemic drug exposure comparable to the reference product while improving patient convenience and ease of administration. BioNxt is pursuing a hybrid regulatory pathway in Europe based on demonstration of bioequivalence to the reference product, Mavenclad®. About BioNxt Solutions Inc. BioNxt Solutions Inc. is a bioscience innovator focused on next-generation drug delivery platforms, diagnostic screening systems, and active pharmaceutical ingredient development. Its proprietary platforms include sublingual thin films, transdermal patches, oral tablets, and a new targeted chemotherapy platform designed to deliver cancer drugs more selectively to tumors with the goal of reducing systemic exposure. With research and development operations in North America and Europe, BioNxt is advancing regulatory approvals and commercialization efforts, primarily focused on European markets. BioNxt is committed to improving healthcare by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide. BioNxt is listed on the Canadian Securities Exchange: BNXT, OTC Markets: BNXTF and trades in Germany under WKN: A3D1K3. To learn more about BioNxt, please visit . Investor Relations & Media Contact Email: investor.relations@bionxt.com Wolfgang Probst Co-Founder, CFO & Director Phone: +49 151 25284192 Hugh Rogers Co-Founder, CEO & Director Phone: +1 604-250-6162 Web: LinkedIn: Instagram: Cautionary Statement Regarding "Forward-Looking" Information This news release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable Canadian securities laws (collectively, "forward-looking statements"). Forward-looking statements are based on management's current expectations, estimates, projections, beliefs and assumptions as of the date of this news release and are subject to known and unknown risks, uncertainties and other factors that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements in this news release include, but are not limited to, statements regarding the completion, review and planned submission of the Investigational Medicinal Product Dossier (IMPD); the planned submission of a Clinical Trial Application (CTA); the timing, design, initiation and completion of planned human bioequivalence studies; the continued development and advancement of BNT23001 and the Company's proprietary oral dissolvable film (ODF) platform; anticipated regulatory review processes and approvals; the Company's hybrid regulatory pathway in Europe; the therapeutic, commercial and strategic potential of its product candidates and drug delivery technologies; future development activities; intellectual property protection; commercialization, licensing and strategic partnering opportunities; and the achievement of future development, regulatory and commercial milestones. Forward-looking statements involve significant risks, uncertainties and assumptions, many of which are beyond the Company's control. These include, without limitation, risks associated with pharmaceutical research and development; formulation development; manufacturing and scale-up; analytical method development; preclinical and clinical testing; regulatory review, approvals and inspections; preparation and acceptance of regulatory submissions; intellectual property protection and enforcement; reliance on third-party manufacturers, suppliers, contract research organizations and development partners; product performance; financing requirements; market acceptance; competitive technologies; and general economic, financial and capital market conditions. There can be no assurance that the Company's planned regulatory submissions, clinical studies or development activities will proceed as currently anticipated or at all, that regulatory authorities will accept the Company's submissions or grant required approvals, that intellectual property protection will be obtained or maintained as expected, or that any product candidate will successfully complete clinical development or achieve commercialization. Readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable securities laws, BioNxt Solutions Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Mavenclad® is a registered trademark that is not owned by, affiliated with, sponsored by, or associated with BioNxt Solutions Inc. SOURCE: BioNxt Solutions Inc. View the original press release on ACCESS Newswire

Clinical Study

06 Aug 2026

·firstwordpharma.com

Boosted by new rare disease pillar, Merck KGaA lifts sales outlook for the year

Merck KGaA raised its sales forecast for 2026 after second-quarter results showed its still-young rare diseases business, set up as a new strategic pillar of its Healthcare segment, is already pulling its weight.The company now expects full-year sales of €21 billion to €21.8 billion — up from its earlier guidance of €20.4 billion to €21.4 billion — with organic growth projected at 1% to 3%.Sales in the Healthcare segment reached €2.2 billion in the quarter, representing reported growth of 2.4%, but an organic decline of 3.4% as certain established products lost ground. However, that was partially offset by portfolio contributions from the $3.9-billion acquisition of SpringWorks Therapeutics a year ago.Rare disease medicines contributed €115 million in quarterly sales. The franchise includes Ogsiveo, a treatment for progressing desmoid tumors, and Gomekli, which is approved for neurofibromatosis type 1-associated plexiform neurofibromas. The products, both added through the SpringWorks takeout, generated sales of €75 million and €39 million, respectivelyPimicotinib, an oral CSF-1R inhibitor for tenosynovial giant cell tumour, generated low single-digit million-euro sales in the quarter following its approval in China last December. Merck exercised its option on the drug last year from Abbisko Therapeutics for $85 million.Within Healthcare's specialty care portfolio, Erbitux provided a bright spot, with sales increasing 5.3% to €303 million despite ongoing competition in China, thanks to stronger demand in Europe and Latin America and a recent EU label extension in colorectal cancer.However, Mavenclad sales (-10.3%, €275 million) were down amid generic competition in the US, while sales of Bavencio (-18.3%, €130 million) and Rebif (-10.2%, €107 million) also saw double-digit declines.Tariff refundsRevenues in the Life Science segment increased by 6.4% to € 2.4 billion. Since taking over from Belén Garijo in May, new CEO Kai Beckmann has moved quickly on the dealmaking front. In June, he brokered the company's largest deal in over a decade, agreeing to buy life science firm Bio-Techne for about $11.3 billion.Merck also raised its full-year outlook for both its Healthcare and Life Science businesses. Healthcare is now expected to earn sales of about €8.4 billion to €8.7 billion despite an anticipated 2%-4% organic decline year-over-year, while Life Science sales are forecast at €9.3 billion to €9.6 billion, representing 5%-7% organic growth.The Life Science guidance includes a potential headwind of around €40 million from tariff refunds to customers.€1.00 = $1.15250866

Drug ApprovalAcquisitionBiosimilar

100 Deals associated with Cladribine

External Link

KEGG	Wiki	ATC	Drug Bank
D01370	Cladribine	L04AA40 L01BB04	DB00242

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Multiple Sclerosis	United States	EMD Serono, Inc.	29 Mar 2019
Multiple Sclerosis, Relapsing-Remitting	Canada	EMD Serono, Inc.	30 Nov 2017
Multiple sclerosis relapse	European Union	Merck Europe BV	22 Aug 2017
Multiple sclerosis relapse	Iceland	Merck Europe BV	22 Aug 2017
Multiple sclerosis relapse	Liechtenstein	Merck Europe BV	22 Aug 2017
Multiple sclerosis relapse	Norway	Merck Europe BV	22 Aug 2017
Anemia	China	Zhejiang Hisun Pharmaceutical Co., Ltd.	15 Nov 2005
Neutropenia	China	Zhejiang Hisun Pharmaceutical Co., Ltd.	15 Nov 2005
Thrombocytopenia	China	Zhejiang Hisun Pharmaceutical Co., Ltd.	15 Nov 2005
Mantle-Cell Lymphoma	Japan	Clinigen KK	16 Dec 2002
Non-Hodgkin Lymphoma	Japan	Clinigen KK	16 Dec 2002
Hairy Cell Leukemia	United States	Janssen Pharmaceuticals, Inc.	26 Feb 1993

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Myasthenia Gravis	Phase 3	United States	Merck Healthcare KGaA	25 Jun 2024
Myasthenia Gravis	Phase 3	China	Merck Healthcare KGaA	25 Jun 2024
Myasthenia Gravis	Phase 3	Japan	Merck Healthcare KGaA	25 Jun 2024
Myasthenia Gravis	Phase 3	Argentina	Merck Healthcare KGaA	25 Jun 2024
Myasthenia Gravis	Phase 3	Australia	Merck Healthcare KGaA	25 Jun 2024
Myasthenia Gravis	Phase 3	Belgium	Merck Healthcare KGaA	25 Jun 2024
Myasthenia Gravis	Phase 3	Bulgaria	Merck Healthcare KGaA	25 Jun 2024
Myasthenia Gravis	Phase 3	Canada	Merck Healthcare KGaA	25 Jun 2024
Myasthenia Gravis	Phase 3	France	Merck Healthcare KGaA	25 Jun 2024
Myasthenia Gravis	Phase 3	Germany	Merck Healthcare KGaA	25 Jun 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EAN2026	Not Applicable	Multiple Sclerosis	145	Cladribine (RRMS)	mvhmdajlsj(dsktqvhvse) = Common adverse events included fatigue, herpes zoster, and alopecia jpoaixvrcv (uyvpoldput ) View more	Positive	26 Jun 2026
NCT02250937 (Pubmed \| Transplant Cell Ther)	Phase 2	Acute Myeloid Leukemia \| Myelodysplastic Syndromes	116	busulfabusulfanfludarabine+cladribine (Arm A (busulfan 80mg/m2 on days -13 and -12))	meykfimfhd(oncigrlbbc) = lptktpxmbz hiwjqotoza (qofcuiwqkr, 37.4 - 63.4) View more	Positive	01 Jun 2026
				busulfabusulfanfludarabine+cladribine (Arm B (busulfan 80mg/m2 on days -20 and -13))	meykfimfhd(oncigrlbbc) = xddxcgtcoo hiwjqotoza (qofcuiwqkr, 49.9 - 75.4) View more
ASCO2026	Not Applicable	Precursor B-Cell Lymphoblastic Leukemia-Lymphoma	53	Cladribine/cyclophosphamide	chtvqqqcsi(nlvmazcito) = bgnctclivp tplztbridg (agmzdebehz ) View more	Positive	29 May 2026
				Fludarabine/cyclophosphamide	chtvqqqcsi(nlvmazcito) = rdwuqblmas tplztbridg (agmzdebehz ) View more
ASCO2026	Not Applicable	Acute Myeloid Leukemia \| High Risk Myelodysplastic Syndrome	72	Cladribine (CLAD) + low-dose AraC (LDAC) + venetoclax (VEN)	csydvudvci(ewrcdbornn) = hmkaucwcok njuikworag (fxdkdcuuec ) View more	Positive	29 May 2026
EHA2026	Phase 2	Refractory Ph-Like Acute Lymphoblastic Leukemia	30	CAV regimen (Cladribine+Venetoclax+Cytarabine)	sucrmogmwc(bhrcibzdyg) = 10% unkkycptbc (txkkjdtohh ) View more	Positive	12 May 2026
NCT04708054 (EHA2026)	Phase 2	Acute Myeloid Leukemia TP53 \| FLT3 mutations	50	Myeloablative busulfan+fludarabine+cladribine+thiotepa+venetoclax	xdengbefrv(zuclvydbqa) = dzvywklail xxeyybrcow (lweqddjwrj, 11 - NR) View more	Positive	12 May 2026
				Myeloablative busulfan+fludarabine+cladribine+thiotepa+venetoclax (TP53 wildtype)	ioqnloldvw(pubebuwrmv) = tqejtberye weugoljdhk (jmblmdmqsr ) View more
EHA2026	Not Applicable	Acute Myeloid Leukemia	64	Clad/LDAC + VEN (Newly Diagnosed)	rmmjesbdpy(tmhpcivnwb) = wvuutqvdoc ngfglamktb (jrvlucksch ) View more	Positive	12 May 2026
				Clad/LDAC + VEN (Relapsed/Refractory)	rmmjesbdpy(tmhpcivnwb) = qfjgfubulh ngfglamktb (jrvlucksch ) View more
NCT04708054 (EHA2026)	Phase 2	High Risk Myelodysplastic Syndrome	50	MYELOABLATIVE FRACTIONATED BUSULFAN, FLUDARABINE, CLADRIBINE, THIOTEPA, AND VENETOCLAX (CLADILLAC) CONDITIONING	ytiteyphbc(ofcluvbrpf) = pnmhchsneo msnnxcxmsf (kgvzdzqyso, 11 months - NR) View more	Positive	12 May 2026
				MYELOABLATIVE FRACTIONATED BUSULFAN, FLUDARABINE, CLADRIBINE, THIOTEPA, AND VENETOCLAX (CLADILLAC) CONDITIONING (TP53 wildtype patients)	tugnwkpgny(nxdxiezawk) = zozwfvioll avdttbzqqo (hvspnhnrof ) View more
NCT05365035 (EHA2026)	Phase 2	High Risk Myelodysplastic Syndrome	41	Cladribine + Low-Dose Cytarabine + Venetoclax (alternating with Azacitidine + Venetoclax)	cqtwyljoqi(gbkelpsvcf) = jhvunupcsa nilrfvqxeb (dkdgrqxxhf ) View more	Positive	12 May 2026
				Cladribine + Low-Dose Cytarabine + Venetoclax (alternating with Azacitidine + Venetoclax) (newly diagnosed)	cqtwyljoqi(gbkelpsvcf) = lnzfruyirb nilrfvqxeb (dkdgrqxxhf ) View more
EHA2026	Not Applicable	Refractory acute myeloid leukemia	16	Low-dose CytarabineCladribine + Low-dose CytarabineCladribineytarabine + Low-dose CytarabineCladribine	fbeskatwtn(lrfdrhaekc) = nzpnwpeiem xlkrkvmmwj (rvgalwwajy ) View more	Positive	12 May 2026

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis