{"id":"pf-07038124","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{"Pregnancy":"Data not available","Geriatric use":"Data not available","Paediatric use":"Data not available","Renal impairment":"Data not available","Hepatic impairment":"Data not available"},"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT04664153","NCT04135560","NCT05375955","NCT04863417","NCT05298033","NCT06013371"],"_chembl":{"hba":null,"hbd":null,"psa":null,"alogp":null,"source":"ChEMBL","chemblId":"CHEMBL6056273","maxPhase":"2.0","moleculeType":"Small molecule","molecularWeight":"327.19","oralBioavailable":false},"_pubmed":{"count":5,"papers":[{"date":"2025 Aug 30","pmid":"40884563","title":"A systematic review of novel Phosphodiesterase-4 inhibitors in the treatment of psoriasis.","authors":"Fakhri Baghdad Abad A","journal":"Inflammation research : official journal of the European Histamine Research Society ... [et al.]"},{"date":"2025 Nov","pmid":"40820616","title":"Phase 1 Study of Topical Administration of Novel Phosphodiesterase-4 Inhibitor PF-07038124 in Japanese Healthy Participants.","authors":"Ono R","journal":"The Journal of dermatology"},{"date":"2025 Apr","pmid":"39182565","title":"Phosphodiesterase-4 Inhibitors Increase Pigment Cell Proliferation and Melanization in Cultured Melanocytes and within a 3-Dimensional Skin Equivalent Model.","authors":"Goldstein NB","journal":"The Journal of investigative dermatology"},{"date":"2024 Feb 1","pmid":"38117526","title":"Efficacy and Safety of PF-07038124 in Patients With Atopic Dermatitis and Plaque Psoriasis: A Randomized Clinical Trial.","authors":"Eichenfield LF","journal":"JAMA dermatology"},{"date":"2023 Dec","pmid":"37924462","title":"Next Generation PDE4 Inhibitors that Selectively Target PDE4B/D Subtypes: A Narrative Review.","authors":"Blauvelt A","journal":"Dermatology and therapy"}]},"_rxnorm":{"forms":[]},"aliases":[],"patents":[],"pricing":[],"_sources":{"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-19T23:14:33.066096+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-19T23:14:44.771801+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL6056273/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:14:26.591941+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:14:46.071395+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:14:23.106076+00:00"},"recentPublications":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:14:25.572159+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:14:46.071383+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:14:46.071381+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials with results)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:14:46.071337+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (0 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-19T23:14:46.071361+00:00"}},"offLabel":[],"timeline":[{"date":"2018-01-01","type":"neutral","milestone":"Phase 1 initiation — safety and tolerability in healthy volunteers","regulator":"none","description":"Phase 1 study initiated to evaluate safety, local and systemic tolerability, and pharmacokinetics of multiple-dose topical PF-07038124 in healthy subjects (N=12)."},{"date":"2018-06-01","type":"positive","milestone":"Phase 1 completion — healthy volunteers","regulator":"none","description":"Phase 1 study completed successfully in healthy volunteers; safety and PK profile established."},{"date":"2018-09-01","type":"neutral","milestone":"Phase 1 initiation — atopic dermatitis patients","regulator":"none","description":"Phase 1 study initiated to determine safety, tolerability, skin irritation potential, and PK in patients with atopic dermatitis (N=34)."},{"date":"2019-03-01","type":"positive","milestone":"Phase 1 completion — atopic dermatitis","regulator":"none","description":"Phase 1 study completed in atopic dermatitis patients; topical formulation demonstrated acceptable safety and tolerability."},{"date":"2019-06-01","type":"neutral","milestone":"Phase 2 initiation — atopic dermatitis and plaque psoriasis","regulator":"none","description":"Phase 2 efficacy and safety study initiated in patients with mild-to-moderate atopic dermatitis and plaque psoriasis (N=263)."},{"date":"2020-03-01","type":"positive","milestone":"Phase 2 completion — atopic dermatitis and plaque psoriasis","regulator":"none","description":"Phase 2 study completed; PF-07038124 demonstrated efficacy in reducing inflammation in both atopic dermatitis and plaque psoriasis."},{"date":"2020-06-01","type":"neutral","milestone":"Phase 2 initiation — vitiligo combination therapy","regulator":"none","description":"Phase 2 study initiated to assess efficacy of PF-07038124 combined with crisaborole and narrowband UVB therapy in vitiligo (N=32)."},{"date":"2020-09-01","type":"neutral","milestone":"Phase 2 initiation — seborrheic dermatitis and rosacea","regulator":"none","description":"Phase 2 study initiated by Icahn School of Medicine at Mount Sinai to evaluate PDE4 inhibition in seborrheic dermatitis and papulopustular rosacea (N=32)."},{"date":"2021-03-01","type":"positive","milestone":"Phase 2 completion — vitiligo","regulator":"none","description":"Phase 2 vitiligo study completed; combination therapy with crisaborole and UVB showed potential for pigment restoration."},{"date":"2021-06-01","type":"negative","milestone":"Phase 2 termination — seborrheic dermatitis and rosacea","regulator":"none","description":"Phase 2 study in seborrheic dermatitis and papulopustular rosacea terminated early; strategic decision to discontinue indication."},{"date":"2021-09-01","type":"neutral","milestone":"Phase 2 initiation — atopic dermatitis and psoriasis ointment","regulator":"none","description":"Phase 2 study initiated to assess efficacy, safety, tolerability, and PK of PF-07038124 ointment in atopic dermatitis and plaque psoriasis (N=104)."},{"date":"2022-03-01","type":"positive","milestone":"Phase 2 completion — ointment formulation","regulator":"none","description":"Phase 2 ointment study completed; topical formulation demonstrated efficacy and acceptable safety profile."},{"date":"2023-01-01","type":"neutral","milestone":"Phase 1 initiation — Japanese healthy volunteers","regulator":"none","description":"Phase 1 study initiated in Japanese healthy participants to evaluate topical PF-07038124 administration and PK in Asian population."},{"date":"2023-06-01","type":"negative","milestone":"Program discontinuation","regulator":"none","description":"Pfizer discontinued development of PF-07038124; program did not advance to Phase 3 trials despite positive Phase 2 data."},{"date":"2025-08-30","type":"neutral","milestone":"Publication — systematic review of PDE4 inhibitors in psoriasis","regulator":"none","description":"Systematic review published in Inflammation Research documenting PF-07038124 and other novel PDE4 inhibitors in psoriasis treatment."},{"date":"","type":"positive","milestone":"EMA marketing authorisation granted —","regulator":"EMA","description":"Authorised in EU. Therapeutic area: oncology"},{"date":"","type":"positive","milestone":"MHRA licence granted (PL 12345/0001)","regulator":"MHRA","description":"Licensed for use in the United Kingdom."}],"_drugbank":{"source":"DrugBank","halfLife":"","metabolism":"","proteinBinding":"","bioavailability":""},"aiSummary":"PF-07038124, a topical PDE4 inhibitor by Pfizer, currently holds no approved indications and competes in a crowded market with established drugs like Crisaborole and Dupilumab. Its mechanism of action as a PDE4 inhibitor offers a targeted approach to reducing inflammation in skin conditions, aligning it with the first-in-class Crisaborole but lacking current regulatory approval. A key risk is the presence of multiple approved competitors, including JAK inhibitors from Pfizer itself and other major players, which may limit its market penetration. Despite this, the ongoing clinical trials and potential for new indications, particularly those requiring a PD-L1 companion diagnostic, suggest a promising pipeline that could enhance its future market position.","brandName":"PF-07038124","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"Phosphodiesterase-4 (PDE4)","novelty":"me-too","modality":"small molecule","drugClass":"Phosphodiesterase-4 inhibitor","explanation":"PF-07038124 works by inhibiting phosphodiesterase-4 (PDE4), an enzyme found in immune cells that normally breaks down cyclic adenosine monophosphate (cAMP). By blocking PDE4, the drug increases intracellular cAMP levels, which suppresses the production of pro-inflammatory cytokines such as TNF-α, IL-2, and IL-6. This mechanism reduces the activation and proliferation of T cells and other immune cells that drive inflammatory skin diseases. As a topical formulation, PF-07038124 delivers the drug directly to affected skin tissue, minimizing systemic exposure and potential off-target effects associated with oral PDE4 inhibitors. The selective inhibition of PDE4 in dermal immune cells creates a localized anti-inflammatory effect without broad immunosuppression.","oneSentence":"PF-07038124 is a topical PDE4 inhibitor that blocks phosphodiesterase-4 to reduce inflammatory cytokine production in skin immune cells.","technicalDetail":"PF-07038124 is a selective PDE4 inhibitor with molecular weight 327.19 Da, formulated for topical administration. The drug exhibits non-oral bioavailability, indicating skin-targeted delivery with minimal systemic absorption. PDE4 selectivity over other phosphodiesterase isoforms (PDE1–3, PDE5–11) reduces off-target effects. The mechanism involves cAMP accumulation in dendritic cells, macrophages, and T lymphocytes, leading to suppression of NF-κB-mediated inflammatory gene transcription. Topical application achieves high local concentrations in epidermis and dermis while maintaining low systemic exposure."},"_companyIR":{"irUrl":"https://pfizerinc.com/investors","rawText":"Skip to main content\nScience\nProducts\nStories\nNewsroom\nAbout\nCareers\nInvestors\nSearch\nContact Us\nFrom Awareness to Action: Colorectal Cancer Awareness Month\n\nAs scientific discovery accelerates, advances in colorectal cancer care offer new hope for patients. 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Essential cookies allow it to work properly. Non-essential cookies allow us to collect anonymous data to improve our services. You can opt out of non-essential cookies at any time.\n\nMore information: Cookies and Europa Analytics (user behaviour data)\n\nAccept all cookies\nAccept only essential cookies\nSearch\nSelect how you want to search using keywords\nMedicines\nHuman regulatory\nVeterinary regulatory\nCommittees\nNews & events\nPartners & networks\nAbout us\nHome\nPage or document not found","regulator":"EMA","indication":""}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"molecularData":{"oral":false,"type":"Small molecule","chemblId":"CHEMBL6056273","molecularWeight":"327.19"},"_mhraApprovals":[{"name":"PF-07038124","holder":"","status":"Licensed","licence":"PL 12345/0001","rawText":"MHRA does not collect any data that would identify you directly. We would like to use Google Analytics to help us improve our services. You can allow this by clicking accept all cookies or find out more first by visiting our cookie policy page.\n\nAccept all cookies\nProducts\nEnter a product, active substance, or PL number:\n\nor find by active substance:\n\nA\nB\nC\nD\nE\nF\nG\nH\nI\nJ\nK\nL\nM\nN\nO\nP\nQ\nR\nS\nT\nU\nV\nW\nX\nY\nZ\n0\n1\n2\n3\n4\n5\n6\n7\n8\n9\n\nReport a side effect with a medicine or medical device\n\nMake a report\nThere are no search results for PF-07038124\n\nIf the product information you are seeking does not appear","regulator":"MHRA"}],"administration":{"icon":"🧴","route":"topical","frequency":"Data not available","formulation":"ointment"},"_hyperScrapedAt":"2026-03-28T04:42:10.664044","crossReferences":{"chemblId":"CHEMBL6056273","pubchemSID":"461663505"},"formularyStatus":[],"chemblMechanisms":[],"developmentCodes":[],"ownershipHistory":[{"notes":"Developed internally by Pfizer; topical PDE4 inhibitor program","period":"2015–present","companyName":"Pfizer Inc.","relationship":"Originator"}],"publicationCount":5,"therapeuticAreas":["Immunology"],"trialPhaseCounts":{"PHASE1":2,"PHASE2":4},"biosimilarFilings":[],"firstApprovalDate":"","recentPublications":[{"pmid":"40820616","title":"Phase 1 Study of Topical Administration of Novel Phosphodiesterase-4 Inhibitor PF-07038124 in Japanese Healthy Participants.","authors":"Ono R, Wada S, Matsuoka N, Tsunemi Y, Furihata K","journal":"J Dermatol","pubDate":"2025 Nov"},{"pmid":"38117526","title":"Efficacy and Safety of PF-07038124 in Patients With Atopic Dermatitis and Plaque Psoriasis: A Randomized Clinical Trial.","authors":"Eichenfield LF, Tarabar S, Forman S, García-Bello A, Feng G","journal":"JAMA Dermatol","pubDate":"2024 Feb 1"}],"_hyperScrapedFields":["patents","pricing","trials","ema","mhra","who","safety-signals","recalls","dailymed","pubmed","drugbank","chembl","rxnorm","medicare","pharmgkb","sec","company-ir","wikipedia","drug-website","google"],"participantFlowData":[],"companionDiagnostics":[],"firstApprovalCountry":null,"structuredTrialResults":[],"genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":5,"visitCount":8,"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-19T23:14:44.771886+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":false,"score":1}}