TRIALISTMD · Drug Intelligence Platform
FDA APPROVED 2022
AhR Agonist · Dermatology · Plaque Psoriasis
Tapinarof
VTAMA™ · Dermavant Sciences Inc.
Tapinarof is a first-in-class aryl hydrocarbon receptor (AhR) agonist for topical use. Activation of the AhR signaling pathway downregulates pro-inflammatory cytokines including IL-17A/F, IL-4, IL-5, IL-6, IL-13, and eotaxin, while upregulating skin barrier proteins including filaggrin, hornerin, and involucrin. Applied once daily as a 1% cream, tapinarof requires no black box warning and carries no contraindications. Approved May 2022 for the topical treatment of plaque psoriasis in adults, it represents a novel non-steroidal mechanism in the dermatology armamentarium.
Drug Overview
NDA 215272
✓ NO BOXED WARNING — Novel topical AhR agonist mechanism: Tapinarof carries no Boxed Warning and no contraindications. It is a non-steroidal, non-immunosuppressive small molecule that acts by agonizing the aryl hydrocarbon receptor, a novel mechanism distinct from corticosteroids, vitamin D derivatives, calcineurin inhibitors, and PDE4 inhibitors. The safety database from vehicle-controlled studies and the long-term extension (Study 3003) did not identify any systemic safety concerns requiring a Boxed Warning. One death (myocardial infarction) reported in Study 3003 was considered unrelated to treatment.
Indication
Plaque Psoriasis — Adults
Topical treatment of plaque psoriasis in patients 18 years and older. First-in-class AhR agonist approved for any indication.
Mechanism of Action
AhR Agonist
Activates aryl hydrocarbon receptor (AhR) signaling; downregulates IL-17A/F, IL-4, IL-5, IL-6, IL-13, eotaxin; upregulates filaggrin, hornerin, and involucrin (skin barrier proteins).
Primary Efficacy (Wk 12) — Study 3001
35% / 6%
PGA Treatment Success: 35% tapinarof vs 6% vehicle; difference 29% (95% CI: 23%, 36%); p<0.001
Primary Efficacy (Wk 12) — Study 3002
40% / 6%
PGA Treatment Success: 40% tapinarof vs 6% vehicle; difference 34% (95% CI: 27%, 41%); p<0.001
Drug Class & Chemistry
| Property | Detail |
|---|---|
| Pharmacologic class | Aryl hydrocarbon receptor (AhR) modulating agonist |
| Chemical name | 3,5-dihydroxy-4-isopropyl-trans-stilbene; also known as (E)-2-isopropyl-5-styrylbenzene-1,3-diol |
| Empirical formula | C₁₇H₁₈O₂; molecular weight 254.32 |
| Physical description | White to pale brown powder |
| Formulation | Cream, 1%; each gram contains 10 mg tapinarof in a white to off-white cream base |
| Sponsor | Dermavant Sciences GMBH / Dermavant Sciences Inc., 3780 Kilroy Airport Way, Long Beach, CA 90806 |
| Initial U.S. Approval | 2022 |
| Code name | N/A (prior research name: GSK2894512) |
AhR Pathway — Mechanism Detail
Mechanism of Action (Section 12.1): Tapinarof is an aryl hydrocarbon receptor (AhR) agonist. The specific mechanisms by which VTAMA cream exerts its therapeutic action in psoriasis patients are unknown. Preclinical data indicate that AhR activation downregulates pro-inflammatory cytokines (IL-4, IL-5, IL-6, IL-13, IL-17A, IL-17F, eotaxin) and upregulates skin barrier proteins (filaggrin, hornerin, involucrin), providing a dual anti-inflammatory and barrier-restoration effect.
Source: NDA 215272 label, Ref ID 4986645, Revised 5/2022; NDA 215272 Multi-disciplinary Review, Ref ID 4984343.
Clinical Efficacy
Section 14 — PSOARING 1 & 2
Trial Design: Two identically designed Phase 3, randomized, multicenter, double-blind, vehicle-controlled, parallel-group trials (DMVT-505-3001 [PSOARING 1; NCT03956355] and DMVT-505-3002 [PSOARING 2; NCT03983980]). Total 1,025 subjects with mild-to-severe plaque psoriasis randomized 2:1 to tapinarof cream 1% or vehicle QD for 12 weeks. BSA involvement 3%–20%; baseline PGA ≥2.
Total Subjects (Both Trials)
1,025
683 tapinarof, 342 vehicle; 2:1 randomization; 50 to 60 centers in the U.S. and Canada
Treatment Duration
12 Weeks
84 days; once-daily application to all affected areas regardless of anatomic location
Median Disease Duration at Baseline
51 yrs
Median age 51; 82% moderate disease; 8% severe; mean BSA 7.8–8.2% (range 3–20%)
Remission Duration (PGA 0 Subjects)
114 days
Median time to first worsening (PGA ≥2) in 73 subjects who achieved PGA 0 at Week 12 and had VTAMA withdrawn; 95% CI: 85, 142
Primary Efficacy Endpoint — PGA Treatment Success at Week 12
PGA Treatment Success = PGA score of 0 (“Clear”) or 1 (“Almost Clear”) with ≥2-grade improvement from baseline. ITT population; multiple imputation for missing data.
DMVT-505-3001 (PSOARING 1) · NCT03956355 · N=510 (Tapinarof 340, Vehicle 170)
Difference: 29% (95% CI: 23%, 36%); Relative Risk: 5.8 (95% CI: 2.9, 11.5); p<0.001
DMVT-505-3002 (PSOARING 2) · NCT03983980 · N=515 (Tapinarof 343, Vehicle 172)
Difference: 34% (95% CI: 27%, 41%); Relative Risk: 6.1 (95% CI: 3.3, 11.4); p<0.001
Secondary Efficacy Endpoints at Week 12
PASI-75 Response (≥75% improvement in PASI from baseline)
Study 3001: Difference 26% (95% CI: 19%, 33%), p<0.001 · Study 3002: Difference 41% (95% CI: 34%, 47%), p<0.001
PASI-90 Response (≥90% improvement in PASI from baseline)
Study 3001: Difference 17% (95% CI: 13%, 22%), p<0.001 · Study 3002: Difference 18% (95% CI: 13%, 23%), p<0.001
Combined Efficacy Summary Table
| Endpoint | Study 3001 Tapinarof N=340 | Study 3001 Vehicle N=170 | Study 3002 Tapinarof N=343 | Study 3002 Vehicle N=172 |
|---|---|---|---|---|
| PGA Treatment Success (primary) | 35% | 6% | 40% | 6% |
| PASI-75 | 36% | 10% | 48% | 7% |
| PGA 0 or 1 (unrestricted) | 38% | 10% | 44% | 8% |
| PASI-90 | 19% | 2% | 21% | 2% |
| Mean change in %BSA (LS Mean) | −3.5% | −0.2% | −4.2% | +0.1% |
All secondary endpoints statistically superior to vehicle in both trials (p<0.001). ITT population; multiple imputation.
Baseline Demographics (ITT)
| Characteristic | Study 3001 Tapinarof N=340 | Study 3001 Vehicle N=170 | Study 3002 Tapinarof N=343 | Study 3002 Vehicle N=172 |
|---|---|---|---|---|
| Mean Age (SD) | 50 (14) | 49 (13) | 50 (13) | 50 (14) |
| Male, n (%) | 213 (63%) | 86 (51%) | 188 (55%) | 102 (59%) |
| White, n (%) | 286 (84%) | 146 (86%) | 300 (87%) | 138 (80%) |
| Moderate PGA (3), n (%) | 271 (80%) | 133 (78%) | 288 (84%) | 144 (84%) |
| Mean PASI (SD) | 8.7 (4.0) | 9.2 (4.4) | 9.1 (3.7) | 9.3 (4.0) |
| Mean BSA% (SD) | 7.8 (4.6) | 8.2 (5.1) | 7.8 (4.4) | 7.3 (4.1) |
Source: NDA 215272 Multi-disciplinary Review, Ref ID 4984343; NDA 215272 label, Ref ID 4986645, Section 14. NCT IDs: PSOARING 1 = NCT03956355; PSOARING 2 = NCT03983980.
Clinical Pharmacology & Pharmacokinetics
Section 1212.3 Pharmacokinetics — Key Parameters (Day 1 Maximal Use Study, N=21)
Cmax (Day 1)
0.90 ± 1.4 ng/mL
Mean ± SD; following mean daily dose of 5.23 g applied to 27.2% mean BSA (range 21–46%) in subjects with moderate-to-severe plaque psoriasis
AUC₀₋ₗₐₛₜ (Day 1)
4.1 ± 6.3 ng·h/mL
Mean ± SD; Day 1 values in 21-subject maximal use PK study
Cmax (Day 29)
0.12 ± 0.15 ng/mL
Mean ± SD; no accumulation observed with repeat topical application; concentrations decreased substantially from Day 1 to Day 29
AUC₀₋ₗₐₛₜ (Day 29)
0.61 ± 0.65 ng·h/mL
Mean ± SD; substantial reduction from Day 1 AUC confirms no systemic accumulation
BQL Samples
68%
Plasma concentration below quantifiable limits (LLOQ = 50 pg/mL) in 68% of PK samples; at ≥95% BSA involvement, nearly all samples BQL
Plasma Protein Binding
~99%
Human plasma protein binding approximately 99% in vitro; highly protein-bound compound
Absorption, Distribution, Metabolism, Excretion
| Parameter | Detail |
|---|---|
| Absorption | No accumulation with repeat topical application. Systemic exposure very low — 68% of samples BQL at LLOQ 50 pg/mL. Mean daily dose in PK study: 5.23 g. Cmax and AUC declined substantially from Day 1 to Day 29, consistent with resolution of psoriatic lesions reducing absorption. |
| Distribution | Human plasma protein binding approximately 99% in vitro. Terminal half-life could not be reliably estimated in most subjects due to low plasma concentrations; estimated in only 2 of 21 subjects in the maximal use study. |
| Metabolism | Metabolized in the liver via multiple pathways including oxidation, glucuronidation, and sulfation in vitro. Major biotransformation is extensive across species. CYP enzymes responsible for oxidative metabolism studied in human hepatocytes; minor contributions from CYP1A1, 1A2, 2C8, 2C9, 2C19, 2D6, and 3A4/5. |
| Excretion / Half-life | Terminal half-life not reliably estimable in humans due to BQL concentrations in the elimination phase. Low potential for drug interactions given minimal systemic exposure. |
| Cardiac Electrophysiology | At the approved recommended dosage, VTAMA does not prolong the QTc interval to any clinically relevant extent. QT changes well below the regulatory threshold for concern (<10 ms). |
Drug Interaction Profile (In Vitro)
Low DDI potential: Given the minimal systemic exposure from topical application, clinically relevant drug interactions are unlikely. All in vitro studies confirmed no inhibitory or inductive activity on major metabolic enzymes and transporters.
| Category | Finding |
|---|---|
| CYP Inhibition | Not an inhibitor of CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4/5 |
| CYP Induction | Not an inducer of CYP1A2, CYP2B6, or CYP3A4 |
| Transporter Inhibition | Not an inhibitor of BCRP, MATE1, MATE-2K, OAT1, OAT3, OATP1B1, OATP1B3, OCT1, OCT2, or P-gp |
| Transporter Substrate | Not a substrate for BCRP, OATP1B1, OATP1B3, or P-gp |
| Overall DDI Risk | Low potential for clinically significant drug interactions; topical application to target site means CYP inducers would also not impact efficacy |
Pharmacodynamics
| Parameter | Detail |
|---|---|
| Pharmacodynamics | Pharmacodynamics of VTAMA cream are unknown (per label Section 12.2). No established PK/PD relationship for efficacy; systemic plasma concentrations do not predict efficacy as drug acts directly on target tissue. |
| Exposure–Response | No trend observed between PASI/PGA scores and Cmax or Cmin across Phase 2 and Phase 3 studies. No trend between safety endpoints (headache, contact dermatitis, folliculitis) and systemic exposure. |
| Mechanistic PD | AhR agonism → nuclear translocation → downregulation of IL-4, IL-5, IL-6, IL-13, IL-17A, IL-17F, eotaxin; upregulation of filaggrin, hornerin, involucrin. Dual anti-inflammatory and skin-barrier repair mechanism. |
Nonclinical Toxicology (Section 13)
| Study Type | Finding |
|---|---|
| Carcinogenicity (mice) | No drug-related neoplasms after 98 (females) to 102 (males) weeks of daily topical administration at doses up to 3% tapinarof cream (44× MRHD based on AUC) |
| Carcinogenicity (rats) | No drug-related neoplasms in female rats after 83 weeks of subcutaneous administration at doses up to 1 mg/kg/day (9× MRHD based on AUC) |
| Genotoxicity | No evidence of mutagenicity or clastogenicity: negative in Ames assay, in vitro mammalian chromosomal aberration assay, in vitro mouse lymphoma assay, and two in vivo micronucleus assays (mice and rats) |
| Fertility | Tapinarof did not impair female fertility at subcutaneous doses up to 30 mg/kg/day (268× MRHD based on AUC) |
Source: NDA 215272 label, Ref ID 4986645, Sections 12.1–12.3 and 13.1; NDA 215272 Multi-disciplinary Review, Ref ID 4984343, Sections 5 and 6.
Safety & Adverse Drug Reactions
Section 6
Safety Database: 683 subjects exposed to tapinarof in the 12-week vehicle-controlled studies (PSOARING 1 and 2). Long-term exposure data from DMVT-505-3003 (LTE study): 508 tapinarof-treated subjects for up to 40 additional weeks. One death (myocardial infarction) in Study 3003 was considered unrelated to tapinarof.
Adverse Reactions ≥1% (12-Week Controlled Trials, PSOARING 1 + 2)
| Adverse Reaction | VTAMA cream N=683 n (%) | Vehicle cream N=342 n (%) |
|---|---|---|
| Folliculitisa | 140 (20%) | 3 (1%) |
| Nasopharyngitisb | 73 (11%) | 31 (9%) |
| Contact dermatitisc | 45 (7%) | 2 (1%) |
| Headached | 26 (4%) | 5 (1%) |
| Prurituse | 20 (3%) | 2 (1%) |
| Influenzaf | 14 (2%) | 2 (1%) |
aFolliculitis includes application site folliculitis and folliculitis. bNasopharyngitis includes nasopharyngitis, nasal congestion, pharyngitis, RTI viral, rhinorrhea, sinus congestion, upper RTI, and viral upper RTI. cContact dermatitis includes dermatitis, contact dermatitis, hand dermatitis, and rash. dHeadache includes headache, migraine, and tension headache. ePruritus includes application site pruritus, pruritus, generalized pruritus, and genital pruritus. fInfluenza includes influenza and influenza-like illness.
Key Safety Findings
Discontinuation Due to ADRs (>1%)
Contact dermatitis: 2.9% of tapinarof-treated subjects. Folliculitis: 2.8%. These were the only ADRs leading to discontinuation in >1% of subjects.
Urticaria
Two (0.3%) subjects using VTAMA cream developed urticaria in the 12-week controlled trials. In PSOARING 3 (LTE), urticaria was reported in 1.0% of subjects.
LTE Study (PSOARING 3) — Additional Reactions
763 subjects treated for up to 40 additional weeks. New reactions vs. controlled phase: urticaria (1.0%) and drug eruption (0.7%). In LTE: folliculitis 24%, contact dermatitis 9%, pruritus 3%, headache 2%.
Folliculitis — Notable Signal
Folliculitis rate 20% tapinarof vs 1% vehicle in controlled trials. Application site folliculitis included. Folliculitis was the most common ADR and a leading cause of discontinuation (2.8%).
Warnings & Precautions
- Folliculitis — most common adverse reaction (20%); leading cause of treatment discontinuation (2.8%). Monitor for signs of folliculitis during treatment.
- Contact dermatitis — 7% incidence in controlled trials; leading cause of treatment discontinuation (2.9%). Includes application site dermatitis, hand dermatitis, and rash. Discontinue if severe.
- Urticaria — 0.3% in controlled trials; 1.0% in LTE study. Two subjects developed urticaria in controlled phase.
Use in Specific Populations (Section 8)
Pregnancy (8.1)
Available data insufficient to evaluate drug-associated risk of major birth defects, miscarriage, or other adverse maternal/fetal outcomes. Animal data: no significant effects at 268× MRHD (rats) and 16× MRHD (rabbits) based on AUC. Fetal skeletal variations (incomplete ossification of nasal bones) in rats at 34 mg/kg/day (268× MRHD). Fetal survival and viability decreased in rats at ≥6 mg/kg/day (45× MRHD). No effects at 1 mg/kg/day (6× MRHD).
Lactation (8.2)
No data on presence of tapinarof in human milk, effects on breastfed infant, or milk production. Tapinarof detected in rat offspring following maternal subcutaneous dosing, suggesting transfer to milk. Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need. When present in animal milk, likely also present in human milk.
Pediatric Use (8.4)
Safety and efficacy not established in pediatric subjects with psoriasis under 18 years of age. Juvenile animal toxicity: renal pelvic dilatation at ≥15 mg/kg/day (165× MRHD based on AUC). No adverse effects at 1.5 mg/kg/day (11× MRHD). Not approved for pediatric use.
Geriatric Use (8.5)
Of 683 subjects exposed to VTAMA cream in PSOARING 1/2, 99 (14.5%) were ≥65 years and 8 (1.2%) were ≥75 years. No overall differences in efficacy, safety, or tolerability between elderly and younger adult subjects in clinical trials.
Source: NDA 215272 label, Ref ID 4986645, Sections 6.1 and 8; NDA 215272 Multi-disciplinary Review, Ref ID 4984343.
Dosing & Contraindications
Sections 2, 3, 4
No Contraindications: VTAMA cream has no contraindications (Section 4). It is not for oral, ophthalmic, or intravaginal use. Topical external use only.
Standard Dosing
- Apply a thin layer of VTAMA cream to affected areas once daily
- Apply only to psoriasis skin lesions; avoid unaffected areas of skin
- Wash hands after application unless treating the hands
- No dose adjustment specified for body weight or BSA
- Formulation: Cream 1%; each gram contains 10 mg tapinarof
- Supplied in 60 g laminated tubes
Special Populations
- Renal impairment: Not reported in label — systemic exposure minimal with topical use; no dose adjustment expected to be necessary
- Hepatic impairment: Not reported in label — minimal systemic absorption; formal hepatic impairment studies not conducted
- Pediatric (<18 years): Not approved; safety and efficacy not established
- Geriatric (≥65 years): No dose adjustment necessary; no differences in efficacy or safety observed vs. younger adults
- Pregnancy: Use only if potential benefit justifies potential risk; insufficient human data
Contraindications
- None. (Section 4)
Route & Formulation Details
- Route: Topical (cutaneous) only
- NOT for oral, ophthalmic, or intravaginal use
- Active ingredient: tapinarof 10 mg/g (1%)
- Appearance: white to off-white cream
- Apply to any lesion regardless of anatomic location (per pivotal trial design)
Inactive Ingredients (Section 11)
Benzoic acid, butylated hydroxytoluene, citric acid monohydrate, diethylene glycol monoethyl ether, edetate disodium, emulsifying wax, medium-chain triglycerides, polyoxyl 2 stearyl ether, polyoxyl 20 stearyl ether, polysorbate 80, propylene glycol, purified water, and sodium citrate dihydrate.
Source: NDA 215272 label, Ref ID 4986645, Sections 2, 3, 4, and 11.
Labeling — How Supplied, Storage & Handling
Section 16| Item | Detail |
|---|---|
| Product description | VTAMA (tapinarof) cream, 1%; white to off-white cream; each gram contains 10 mg tapinarof |
| Package size | 60 g laminated tubes |
| NDC | 81672-5051-1 |
| Storage temperature | Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) |
| Freezing | Do not freeze |
| Heat | Protect from exposure to excessive heat |
| Child safety | Keep out of reach of children |
| Active ingredient | Tapinarof 10 mg/g (1%) |
| Inactive ingredients | Benzoic acid, butylated hydroxytoluene, citric acid monohydrate, diethylene glycol monoethyl ether, edetate disodium, emulsifying wax, medium-chain triglycerides, polyoxyl 2 stearyl ether, polyoxyl 20 stearyl ether, polysorbate 80, propylene glycol, purified water, and sodium citrate dihydrate |
| Marketed by | Dermavant Sciences Inc., 3780 Kilroy Airport Way, Long Beach, CA 90806 |
| Trademark | VTAMA® is a registered trademark of Dermavant Sciences, GmbH or its affiliates |
| Patents | www.dermavant.com/patents |
Patient Support & Adverse Event Reporting
| Contact Type | Detail |
|---|---|
| Patient / HCP information | www.VTAMA.com or call 1-8DERMAVANT |
| Report adverse reactions (sponsor) | Dermavant Sciences, Inc. at 1-8DERMAVANT |
| Report adverse reactions (FDA) | FDA at 1-800-FDA-1088 or www.fda.gov/medwatch |
| Reference ID (label) | 4986645 |
| Label revision date | Revised: 5/2022; Patient Information issued 5/2022 |
Patient Counseling Information (Section 17)
- Apply VTAMA cream once daily to psoriasis skin lesions only — avoid unaffected areas of skin.
- Wash hands after applying VTAMA cream unless treating the hands. If someone else applies the cream, they should also wash their hands after application.
- VTAMA cream is for external (skin) use only. Do not use in the eyes, mouth, or vagina.
- Inform healthcare provider if pregnant, planning pregnancy, or breastfeeding.
Source: NDA 215272 label, Ref ID 4986645, Sections 16 and 17. Label Revised 5/2022. For current labeling, visit https://www.fda.gov/drugsatfda.
Regulatory History
NDA 215272 — Standard ReviewApplication Type
Original NDA
Standard Review. New Molecular Entity. First-in-class AhR agonist for dermatology. Application Number: 215272Orig1s000.
Reviewing Division
DDD / OII
Division of Dermatology and Dentistry / Office of Immunology and Inflammation, CDER.
PDUFA Goal Date
May 26, 2022
Submitted and received May 26, 2021; PDUFA goal date May 26, 2022.
Approval Date
May 2022
Initial U.S. Approval 2022. First-in-class AhR agonist approved for plaque psoriasis; first new topical non-steroidal mechanism in psoriasis since crisaborole (2016).
Regulatory Timeline
PHASE 3 CONDUCT
PSOARING 1 (DMVT-505-3001; NCT03956355) and PSOARING 2 (DMVT-505-3002; NCT03983980)
Two identically designed Phase 3 randomized, multicenter, double-blind, vehicle-controlled trials in 1,025 subjects with mild-to-severe plaque psoriasis (BSA 3–20%). 2:1 randomization to tapinarof 1% cream or vehicle QD for 12 weeks. Primary endpoint: PGA Treatment Success at Week 12.
MAY 26, 2021
NDA 215272 Submitted and Received
Dermavant Sciences GMBH submitted NDA 215272 for VTAMA (tapinarof) cream, 1% for topical treatment of plaque psoriasis in patients 18 years and older. Standard Review designation. PDUFA goal date: May 26, 2022.
SEPTEMBER 28, 2021
Proprietary Name Review Completed
Proprietary name “VTAMA” accepted as acceptable from both a promotional and safety perspective under NDA 215272 (review by Dr. Madhuri R. Patel, Division of Medication Error Prevention and Analysis).
MAY 2022
FDA Approval — NDA 215272 (VTAMA)
Tapinarof cream 1% QD approved for topical treatment of plaque psoriasis in adults (patients 18 years and older). First-in-class AhR agonist. No Boxed Warning. No contraindications. Label Revised 5/2022; Ref ID 4986645. Multi-disciplinary Review Ref ID 4984343.
Regulatory Submission Summary
| Aspect | Detail |
|---|---|
| Application number | NDA 215272 (Orig1s000) |
| Applicant | Dermavant Sciences GMBH |
| Submission / receipt date | May 26, 2021 |
| PDUFA goal date | May 26, 2022 |
| Review type | Standard Review; Original NDA; New Molecular Entity |
| Pivotal trials | DMVT-505-3001 (NCT03956355) and DMVT-505-3002 (NCT03983980) — two adequate and well-controlled Phase 3 trials |
| Primary endpoint met | Study 3001: 35% vs 6% (difference 29%, p<0.001); Study 3002: 40% vs 6% (difference 34%, p<0.001) |
| Regulatory recommendation | Approval recommended by review team based on favorable benefit/risk assessment |
| Boxed Warning | None |
| Contraindications | None |
| Post-marketing requirements (PMR) | Not reported in label |
| REMS | Not required |
| Priority Review / Breakthrough | Standard Review; no breakthrough or priority designation reported in label or review |
| Reference IDs | 4986645 (label, Revised 5/2022) / 4984343 (multi-disciplinary review) |
| Safety database at approval | 683 subjects in 12-week vehicle-controlled studies; 763 subjects in open-label LTE study (PSOARING 3, DMVT-505-3003) for up to 40 additional weeks |
Source: NDA 215272 Multi-disciplinary Review, Ref ID 4984343; NDA 215272 label, Ref ID 4986645, Revised 5/2022. Reviewed under Division of Dermatology and Dentistry (DDD), Office of Immunology and Inflammation (OII), CDER. Tapinarof is the first AhR agonist approved for dermatological use.
