NCT04697056
- Objective
- Not yet disclosed
- Design
- Not yet disclosed
- Participants
- Not yet disclosed
- Primary endpoint
- Not yet disclosed
- Results
- Results not yet reported; program terminated September 16, 2025.
pharma · Generalized Pustular Psoriasis · Schizophrenia · VNDA
Vanda Pharmaceuticals Netherlands
Vanda Pharmaceuticals Netherlands B.V.
Vanda Pharmaceuticals Netherlands is a pharma organization headquartered in Washington, USA. It trades on NYSE under ticker VNDA. Primary therapeutic focus areas include Generalized Pustular Psoriasis, Schizophrenia, Maj
2200 Pennsylvania Avenue NW, Suite 300E, Washington, DC 20037, US HQ
2003 Founded
600 Employees
Public company Type
VNDA · NYSE Ticker
Company details
- Status
- Public
- HQ
- 2200 Pennsylvania Avenue NW, Suite 300E, Washington, DC 20037, US
- Founded
- 2003
- Employees
- 600
- Programs
- 60
- Drugs
- 19
- Patents
- 96
Imsidolimab
Phase 2 · small molecule · Ichthyosis
Imsidolimab (ANB019-206) is a small-molecule therapeutic candidate developed by Vanda Pharmaceuticals Netherlands B.V. for the treatment of ichthyosis, a group of genetic skin disorders characterized by abnormal keratinization and scaling. The program is currently in Phase 2 development. As of September 16, 2025, the p
Internal code ANB019-206
At a glance
- Sponsor
- Vanda Pharmaceuticals Netherlands B.V.
- Phase
- Phase 2
- Modality
- small_molecule
- Indication
- Ichthyosis
- Status
- terminated
- Trials
- 1
Executive summary
Imsidolimab (ANB019-206) is a small-molecule therapeutic candidate developed by Vanda Pharmaceuticals Netherlands B.V. for the treatment of ichthyosis, a group of genetic skin disorders characterized by abnormal keratinization and scaling. The program is currently in Phase 2 development. As of September 16, 2025, the program has been terminated, marking the end of clinical development for this indication. The specific mechanism of action and molecular target have not been disclosed. Vanda's development strategy for imsidolimab reflected efforts to address an underserved patient population with limited therapeutic options. The termination of the Phase 2 program represents a strategic decision by the sponsor, though the rationale for discontinuation has not been publicly detailed. No regulatory approvals have been achieved, and no next development milestones are currently projected.
Why this program matters
Ichthyosis represents a significant unmet medical need, particularly in severe inherited forms where existing treatments are largely symptomatic and provide limited efficacy. The disease impairs quality of life through chronic skin barrier dysfunction, increased infection risk, and systemic complications in severe cases. The market for ichthyosis therapeutics remains nascent, with few disease-modifying agents available, creating potential commercial opportunity for effective new treatments. Imsidolimab's termination removes one candidate from the competitive landscape, which includes programs such as KB105 (Krystal Biotech), a monoclonal antibody in Phase 2 development. The discontinuation may reflect clinical or commercial considerations, but leaves the ichthyosis therapeutic space with limited near-term pipeline density. Understanding why imsidolimab was discontinued provides insight into development challenges and unmet requirements in this indication, informing future program design by other sponsors pursuing similar therapeutic approaches.
Drug intelligence
Drug Class: Small-molecule therapeutic
Modality: Small molecule
Mechanism of Action: Not yet disclosed
Molecular Target: Not yet disclosed
Route of Administration: Not yet disclosed
Indication: Ichthyosis
Related Therapies: Competitive program KB105 (monoclonal antibody, Krystal Biotech, Phase 2)
First Approval: Not applicable; program terminated in Phase 2
Patent Status: Not yet disclosed
ichthyosis
Also known as: DOC, disorder of cornification, fish scale disease, fish skin disease, ichthyosis (disease)
Overview
Disorders of cornification that are characterized by visible scaling and/or hyperkeratosis of most or all of the skin. Inherited ichthyoses, defined as the generalized form of Mendelian disorders of cornification, affect most or all of the skin. This etiologically and phenotypically heterogenous group of conditions is caused by mutations in various different genes important for keratinocyte differentiation and epidermal barrier function. Acquired forms of ichthyosis can be observed with certain autoimmune, inflammatory, metabolic, endocrine, or infectious diseases or with malignancies.
Treatment landscape
ClinicalTrials.gov lists 19 registered studies for Ichthyosis (AACT aggregate).
Phase breakdown: NA (11), PHASE2 (4), EARLY_PHASE1 (2), PHASE3 (2)
Common investigational therapies:
- Ustekinumab
- Imsidolimab
- placebo
- TMB-001
- Matching Vehicle
- deucravacitinib
- Secukinumab
- Placebo
- Gentamicin Injectable Solution
- monolaurin cream
Disease data sourced from MONDO Disease Ontology (MONDO:0019269), Orphanet — ichthyosis, NCT00004690, NCT00074685, NCT02655861, NCT03041038, NCT03051347, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Clinical development timeline
- Phase 2TBD
Phase 2 enrollment and conduct
ANB019-206 Phase 2 trial (NCT04697056) conducted for ichthyosis indication.
- Phase 22025-09-16
Program termination
Imsidolimab development program terminated as of September 16, 2025.
Competitive landscape
The ichthyosis therapeutic landscape includes KB105 (Krystal Biotech Netherlands B.V.), a monoclonal antibody currently in Phase 2 development. KB105 represents a mechanistically distinct approach (antibody-based) compared to imsidolimab's small-molecule platform. The termination of imsidolimab reduces competitive density in this indication and may reflect challenges specific to small-molecule approaches or clinical outcomes that did not support continued development. KB105's continued advancement suggests that the ichthyosis market remains of interest to sponsors, though the overall pipeline remains limited. The discontinuation of imsidolimab leaves KB105 as a notable remaining candidate in the disclosed competitive set, though other undisclosed programs may exist in earlier development stages.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| KB105 | Krystal Biotech Netherlands B.V. | mab | phase_2 |
| SPESOLIMAB | — | IL36 receptor antagonist | Phase 2 |
| ISOTRETINOIN | — | Retinoic acid receptor agonist | Phase 2 |
| IMSIDOLIMAB | — | IL36 receptor antagonist | Phase 2 |
| DUPILUMAB | — | Interleukin-4 receptor subunit alpha antagonist | Phase 2 |
| ADALIMUMAB | — | TNF-alpha inhibitor | Phase 2 |
| PIMECROLIMUS | — | FK506-binding protein 1A inhibitor | Phase 1 |
| USTEKINUMAB | — | Interleukin-23 inhibitor | Investigational |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
Regulatory intelligence
FDA Status: Not yet disclosed; program terminated in Phase 2, no regulatory submissions reported.
EMA Status: Not yet disclosed; program terminated in Phase 2, no regulatory submissions reported.
PMDA (Japan) Status: Not yet disclosed; program terminated in Phase 2, no regulatory submissions reported.
NMPA (China) Status: Not yet disclosed; program terminated in Phase 2, no regulatory submissions reported.
No approvals, designations, or regulatory interactions have been disclosed for imsidolimab. The program termination in Phase 2 indicates that regulatory approval was not achieved and no further regulatory pathway is anticipated.
Clinical evidence summary
Key questions answered
What is imsidolimab used for?
Imsidolimab was being developed for the treatment of ichthyosis, a genetic skin disorder characterized by abnormal keratinization and scaling. The program has been terminated and the drug is not approved for any indication.
Is imsidolimab approved by the FDA?
No. Imsidolimab is not approved by the FDA. The Phase 2 development program was terminated on September 16, 2025, and no regulatory submissions were made.
What is the mechanism of action of imsidolimab?
The specific mechanism of action of imsidolimab has not been disclosed by Vanda Pharmaceuticals.
Who manufactures imsidolimab?
Imsidolimab is developed by Vanda Pharmaceuticals Netherlands B.V. No manufacturing partner has been disclosed.
What clinical trials support imsidolimab?
One Phase 2 trial (NCT04697056) was conducted for ichthyosis. Detailed trial design, results, and outcomes have not been disclosed.
What is the current development status of imsidolimab?
Imsidolimab development was terminated on September 16, 2025. The program is no longer active and no further development is anticipated.
What is the molecular target of imsidolimab?
The molecular target of imsidolimab has not been disclosed.
What is the drug class of imsidolimab?
Imsidolimab is a small-molecule therapeutic candidate.
How is imsidolimab administered?
The route of administration for imsidolimab has not been disclosed.
Does imsidolimab have any competitors?
Yes. KB105 (Krystal Biotech), a monoclonal antibody, is in Phase 2 development for ichthyosis and represents a competing therapeutic approach.
Why was imsidolimab development terminated?
The specific rationale for termination has not been disclosed by Vanda Pharmaceuticals. The decision was made on September 16, 2025, while the program was in Phase 2.
What is ichthyosis and why is it an important indication?
Ichthyosis is a group of genetic skin disorders characterized by abnormal keratinization, scaling, and skin barrier dysfunction. It represents an unmet medical need with limited effective disease-modifying therapies available.
Is imsidolimab approved in Europe?
No. Imsidolimab is not approved by the EMA or any European regulatory authority. The program was terminated in Phase 2.
Is imsidolimab approved in Japan or China?
No. Imsidolimab is not approved by the PMDA (Japan) or NMPA (China). The program was terminated in Phase 2.
What is the internal code for the imsidolimab program?
The internal code for the imsidolimab ichthyosis program is ANB019-206.
Does Vanda Pharmaceuticals have a partner for imsidolimab?
No development or commercialization partner has been disclosed for imsidolimab.
Entity relationship graph
Imsidolimab → Drug → Target → Indication → Company → Trials → Competitors
Companies
Indication
Trials
Competitors
Analyst insights
Strategic Implications: The termination of imsidolimab in Phase 2 suggests that clinical efficacy, safety, tolerability, or commercial viability did not meet Vanda's advancement criteria. Small-molecule approaches to ichthyosis may face inherent challenges in target engagement, systemic exposure, or skin penetration that were not overcome by this program. The decision to discontinue reflects resource allocation toward other pipeline priorities at Vanda.
Competitive Implications: Imsidolimab's exit removes a small-molecule competitor from the ichthyosis space, potentially reducing near-term competitive pressure on remaining programs such as KB105. However, the termination may also signal that ichthyosis remains a challenging indication for drug development, which could influence sponsor confidence and investment in the space.
Future Catalysts: No further milestones are projected for imsidolimab. Future developments in ichthyosis therapeutics will depend on KB105 and other undisclosed programs. Clinical data from KB105 or other competitors may provide insights into optimal target selection and mechanistic approaches for this indication.
Expected Milestones: None anticipated for imsidolimab; program terminated.
Quick answers
Concise, citable answers optimized for AI answer engines.
- What is imsidolimab?
- A small-molecule therapeutic candidate developed by Vanda Pharmaceuticals for ichthyosis; program terminated in Phase 2.
- Is imsidolimab approved?
- No; program terminated September 16, 2025, in Phase 2 development.
- What is imsidolimab indicated for?
- Ichthyosis, a genetic skin disorder with abnormal keratinization and scaling.
- Who develops imsidolimab?
- Vanda Pharmaceuticals Netherlands B.V.
- What is the mechanism of action?
- Not yet disclosed by the sponsor.
- What is the molecular target?
- Not yet disclosed by the sponsor.
- What is the drug modality?
- Small molecule.
- What is the route of administration?
- Not yet disclosed.
- What development phase is imsidolimab in?
- Phase 2; program terminated as of September 16, 2025.
- What is the internal program code?
- ANB019-206.
- What clinical trial supports imsidolimab?
- NCT04697056, a Phase 2 trial for ichthyosis; results not yet reported.
- Does imsidolimab have a development partner?
- No partner has been disclosed.
- What is the competitive landscape?
- KB105 (Krystal Biotech, monoclonal antibody, Phase 2) is a competing program in ichthyosis.
- Why was imsidolimab terminated?
- Rationale not disclosed; terminated in Phase 2 on September 16, 2025.
- Is imsidolimab approved in the US?
- No; program terminated in Phase 2 before FDA approval.
- Is imsidolimab approved in Europe?
- No; program terminated in Phase 2 before EMA approval.
- Is imsidolimab approved in Japan?
- No; program terminated in Phase 2 before PMDA approval.
- Is imsidolimab approved in China?
- No; program terminated in Phase 2 before NMPA approval.
- What is the unmet need in ichthyosis?
- Limited disease-modifying therapies; existing treatments largely symptomatic with poor efficacy.
- When was imsidolimab terminated?
- September 16, 2025.
- What is the projected peak sales for imsidolimab?
- Not disclosed; program terminated before commercialization.
- What is the patent status of imsidolimab?
- Patent status not yet disclosed.
- What is the lead investigator for imsidolimab?
- Lead investigator not yet disclosed.
- When was imsidolimab first disclosed?
- First disclosure date not yet disclosed.
Evidence & sources
- ClinicalTrials.gov NCT04697056 (clinicaltrials)
- Source: phase (source_attribution)
- MONDO Disease Ontology (MONDO:0019269) (mondo)
- Orphanet — ichthyosis (orphanet)
- NCT00004690 (clinicaltrials_gov)
- NCT00074685 (clinicaltrials_gov)
- NCT02655861 (clinicaltrials_gov)
- NCT03041038 (clinicaltrials_gov)
- NCT03051347 (clinicaltrials_gov)
- AACT (ClinicalTrials.gov aggregate) (aact)
- ClinicalTrials.gov (clinicaltrials_gov)
- Open Targets Platform (opentargets)
Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.