FDA Novel Drug 2025 · No. 46 · NDA 220152
Nereus (tradipitant) is a substance P / neurokinin-1 (NK-1) receptor antagonist approved by the US FDA on 30 December 2025 for the prevention of vomiting induced by motion in adults. It is a prescription-only medicine, not an over-the-counter product, taken as a single 85 mg or 170 mg oral dose on an empty stomach approximately 60 minutes before the motion event.[2]
In the two pivotal boat studies it reduced vomiting incidence from 44% to 18–20% and from 38% to 10–18% against placebo. Nausea, a secondary endpoint, was not significantly reduced in either study — which is why the approved indication covers vomiting rather than motion sickness as a whole.[2]
Nereus launched in the United States on 1 May 2026 at a list price of USD 255 per dose, with a USD 85 cash price through the manufacturer’s direct portal.[4] It is not approved in India, and no CDSCO import or marketing permission for tradipitant is on public record as of August 2026.
- Sponsor
- Vanda Pharmaceuticals Inc.
- Application
- NDA 220152
- Approval date
- 30 Dec 2025
- Review pathway
- Standard review, full approval
- Class position
- First-in-indication for motion sickness
- Orphan drug
- No
- Strength supplied
- 85 mg capsule only
- Availability
- Prescription only, not OTC
- US launch
- 1 May 2026
- India status
- Not approved by CDSCO
- Label revision
- March 2026
Nereus is the first prescription medicine cleared for motion sickness in the United States in more than four decades,[3] and entry number 46 on CDER’s 2025 novel drug approvals list — the final novel approval of that calendar year.[1] This analysis works from the approved prescribing information revised March 2026, the ClinicalTrials.gov records for each study, and the sponsor’s regulatory disclosures.
Mechanism of action
Motion sickness arises from conflict between visual, vestibular and proprioceptive input. That conflict is associated with release of substance P, a neuropeptide that acts at NK-1 receptors in the central nervous system structures governing the emetic reflex. Tradipitant blocks those receptors.
Receptor binding and selectivity
Tradipitant is a selective, high-affinity antagonist of the human substance P / NK-1 receptor. It binds the NK1 receptor with a Ki of 0.062 ± 0.01 nM and blocks substance-P-induced intracellular calcium mobilisation with a Kb of 0.095 ± 0.025 nM.[2]
It has no affinity for NK2, NK3, serotonin (5-HT3), dopamine (D2), cholinergic or histamine (H1) receptors.[2] That selectivity is the pharmacological basis for expecting a different tolerability profile from antihistamines and anticholinergics, which act at exactly those targets and produce the dry mouth, blurred vision and cognitive clouding associated with the older agents.
CNS penetration and receptor occupancy
PET imaging in humans confirmed that tradipitant crosses the blood-brain barrier and occupies brain NK-1 receptors, with dose- and concentration-dependent frontal cortex occupancy reaching a maximum of 93% after multiple 100 mg administrations.[2] Four major plasma metabolites (M2, M3, M4 and M8) bind the NK-1 receptor to a similar degree, so parent drug is not the only pharmacologically active species.[2]
What the label stops short of claiming
Section 12.1 states that the exact mechanism by which tradipitant exerts its therapeutic effect is not fully established.[2] Substance P signalling during sensory conflict is a well-supported model of the emetic pathway, but the sponsor was not able to claim a fully characterised mechanism of action for this product. Descriptions presenting tradipitant as resolving the underlying sensory conflict go further than the approved labelling supports.
Position within the NK-1 antagonist class
NK-1 receptor antagonism is an established antiemetic mechanism. Aprepitant (EMEND) was approved in the United States in March 2003 for chemotherapy-induced nausea and vomiting,[9] and rolapitant and netupitant followed in the same class. Tradipitant is therefore best described as first-in-indication for motion sickness rather than first-in-class: the novelty lies in applying a known mechanism to a condition that had seen no new pharmacologic option in over forty years.
Nor was this an accelerated approval. The label carries no accelerated-approval statement, and the pivotal endpoint was a directly observed clinical outcome — whether subjects vomited — rather than a surrogate marker.[2] Nereus reached the market through standard review of a full NDA.
Clinical evidence: the Motion studies
Two randomised, double-blind, placebo-controlled trials supported the indication: Study 1 (Motion Syros, NCT04327661) and Study 2 (Motion Serifos, NCT05903924).[5][6] Both were real-world provocation studies conducted on boats rather than in a laboratory, which is unusual and strengthens external validity.
Subjects were randomised 1:1:1 to a single dose of 85 mg, 170 mg or placebo approximately 60 minutes before a boat trip scheduled to last 2 to 5 hours. Actual trip duration ranged from 2 to 4.4 hours and peak wave height from 0.3 to 2.5 metres. Subjects with a chronic nausea-inducing disorder were excluded, and no concomitant anti-nausea or anti-emetic medication was permitted.[2]
Across both studies there were 681 subjects, mean age 48 years (range 18–75), 62% female.[2] The primary endpoint in each was the percentage of subjects who vomited during the trip, assessed every 30 minutes using a single-item questionnaire.
| Study | Arm | N | Vomited | Difference vs placebo (95% CI) |
|---|---|---|---|---|
| Study 1 — Motion Syros | Nereus 85 mg | 123 | 20% | −25% (−36, −14) |
| Study 1 — Motion Syros | Nereus 170 mg | 120 | 18% | −26% (−37, −15) |
| Study 1 — Motion Syros | Placebo | 122 | 44% | — |
| Study 2 — Motion Serifos | Nereus 85 mg | 104 | 18% | −19% (−31, −8) |
| Study 2 — Motion Serifos | Nereus 170 mg | 106 | 10% | −27% (−38, −16) |
| Study 2 — Motion Serifos | Placebo | 106 | 38% | — |
Prescribing information Table 2. Differences are unadjusted risk differences; 95% CI by the Wald method. Scroll sideways on a phone. The p-values commonly quoted for these studies (p < 0.0001 and p ≤ 0.0014) appear in the sponsor’s approval announcement rather than the FDA label, which reports intervals only.[2][3]
Vomiting was prevented. Nausea was not.
Worst nausea score was a secondary endpoint, rated over the preceding 30 minutes on a scale from 0 (no nausea) to 4 (very severe). In Study 1 it was 2.4 for the 85 mg arm and 2.3 for 170 mg, against 2.4 for placebo. In Study 2 it was 2.5 for 85 mg and 2.2 for 170 mg, against 2.4 for placebo. These differences did not reach statistical significance in either study.[2]
This is why the approved indication is the prevention of vomiting induced by motion, not the prevention of motion sickness. A patient may take Nereus, avoid vomiting, and still feel substantially nauseated for the duration of the journey. That expectation is worth setting before dispensing.
A third study, Motion Sifnos (NCT03772340), is sometimes described alongside these two. It is a Phase 2 trial of 126 subjects, and the label draws on it only to enlarge the safety dataset for the 170 mg dose, not to support efficacy.[7][2]
Prescribing information in detail
Adverse reactions
Reactions reported in at least 5% of treated subjects and more frequently than placebo. The 85 mg column pools Studies 1 and 2; the 170 mg column pools Studies 1, 2 and 3, so the denominators differ.[2]
| Reaction | 85 mg (N=227) | Placebo (N=228) | 170 mg (N=289) | Placebo (N=291) |
|---|---|---|---|---|
| Somnolence | 6% | 4% | 12% | 6% |
| Headache | 7% | 5% | 10% | 6% |
| Fatigue | 6% | 3% | 8% | 2% |
Placebo rates are shown alongside because the margin over placebo is modest at 85 mg and widens at 170 mg.
- Contraindications: none. Section 4 of the label is empty.[2]
- Alertness is the single warning. Section 5.1 states the drug may impair the mental or physical abilities required to drive a motor vehicle or operate heavy machinery, and that concomitant CNS depressants and strong CYP3A4 inhibitors may increase this effect.[2]
- Cumulative exposure ceiling. Safety beyond 90 total doses has not been established. In a 12-month open-label study of 382 subjects, median exposure was 18 doses, 69% took no more than 30, and 95% took no more than 8 doses in any 30-day period.[2] A larger open-label study, Motion Delos (NCT06138613, 705 participants), remains active with primary completion scheduled for September 2027.[8]
- Rodent thyroid findings. In a 104-week rat study, a dose-related increase in thyroid follicular cell adenomas and carcinomas was observed at all tested doses. The label attributes this to rodent-specific hepatic enzyme induction and considers it not relevant to humans. No increase in tumours occurred in transgenic rasH2 mice.[2]
- Cardiac safety. No clinically significant QTc prolongation was observed at the maximum recommended single dose of 170 mg taken without food.[2]
- Genotoxicity and fertility. Not genotoxic across Ames, chromosomal aberration and mouse micronucleus assays; no effect on fertility or reproductive performance in rats.[2]
Why the empty-stomach instruction matters
Fasted, an 85 mg dose produces a geometric mean Cmax of 84.7 ng/mL, AUC0-inf of 1,839 ng·h/mL and median Tmax of 2.0 hours. At 170 mg fasted, Cmax is 112 ng/mL, AUC0-inf 3,526 ng·h/mL and Tmax 1.50 hours.[2]
With a high-fat meal (800–1,000 calories, 50% fat) the profile changes substantially:[2]
- 85 mg: Cmax increased approximately 4.7-fold, AUC0-inf approximately 2.4-fold, Tmax delayed by 2 hours.
- 170 mg: Cmax increased approximately 6.9-fold, AUC0-inf approximately 2.9-fold, Tmax delayed by 2.5 hours.
Both effects work against the patient. Peak exposure rises into a range where somnolence becomes more likely, and the delay in Tmax can push peak concentration past the start of travel, defeating the timing the dose is designed around. Hence the instruction: at least 1 hour before, or 2 hours after, a full meal.[2]
Distribution, metabolism and elimination
- Elimination half-life approximately 34 hours; apparent oral clearance 41.7 L/h; apparent volume of distribution 1,956 L.
- Plasma protein binding 96% to more than 99%.
- Excretion: approximately 88% of a radiolabelled dose recovered, 80% in faeces and 7% in urine. Unchanged drug was minimal in faeces and not detected in urine.
- Metabolism is extensive and not fully characterised, involving non-CYP450 processes together with CYP3A4, CYP2C19 and to a lesser extent CYP2C8, with glucuronidation by UGT1A4 and UGT2B7.
- Molecular formula C28H16ClF6N5O, molecular weight 587.9. A white to off-white crystalline powder, practically insoluble in water, soluble in methanol.
Figures from Sections 11 and 12.3 of the prescribing information.[2]
Drug interactions
The label carries a single drug interaction subsection, 7.1, naming one interaction: strong CYP3A4 inhibitors may increase tradipitant exposure and the risk of adverse reactions.[2] Tradipitant is a CYP3A4 substrate and a P-gp substrate.
- Tradipitant as the affected drug: exercise caution with strong CYP3A4 inhibitors such as ketoconazole, itraconazole, clarithromycin and ritonavir. No dose adjustment is specified, so the practical step is to counsel against driving and monitor for somnolence.
- Tradipitant as the perpetrator: in vitro data suggest it may both inhibit and induce CYP3A4, but a clinical midazolam study showed no clinically significant change in midazolam or 1-OH-midazolam pharmacokinetics.[2] It does not inhibit CYP1A2, 2B6, 2C8, 2C9, 2C19 or 2D6.
- Transporters: no inhibition of P-gp, BCRP, OATP1B1, OATP1B3, OCT2, OAT1, OAT3, MATE1 or MATE2-K at clinically relevant concentrations.
Alcohol: two separate effects
Pharmacokinetically, co-administration with ethanol increased tradipitant Cmax by 9% and AUC0-24 by 14%, which the label describes as not clinically relevant.[2] The clinically important interaction is pharmacodynamic: alcohol is a CNS depressant, and Section 5.1 warns that CNS depressants add to the alertness impairment. The counselling point is additive drowsiness, not increased drug exposure.
Use in specific populations
- Renal impairment. No dose change for an eGFR of at least 30 mL/min/1.73 m². Tradipitant has not been studied in severe impairment (eGFR 29 or below), and the label directs that its use be avoided in that group.[2]
- Hepatic impairment. Not studied at any degree, Child-Pugh A through C. The label directs avoidance in mild, moderate and severe impairment alike — a stricter position than many single-dose products carry.[2]
- Pregnancy. Human data are insufficient to inform a drug-associated risk. In rats and rabbits, no adverse developmental effects were seen at up to approximately 3.3 and 1.4 times human exposure at the maximum recommended dose.[2]
- Lactation. No human lactation studies have been conducted. Tradipitant is present in rat milk, with pup serum concentrations approximately 1–3% of maternal levels on lactation day 4. Monitor breastfed infants for somnolence.[2]
- Paediatrics. Safety and effectiveness have not been established in patients under 18 years.[2]
- Geriatrics. Of the treated subjects in controlled studies, 69 (13%) were 65 or older and 4 (0.8%) were 75 or older. No overall differences in safety or effectiveness were observed, though greater sensitivity in some older individuals cannot be ruled out on a dataset of that size.[2]
- Storage. Controlled room temperature 25 °C, excursions permitted 15–30 °C; protect from light and moisture. Supplied in 36-count and 60-count HDPE bottles with child-resistant caps and a desiccant.[2]
Screening check before dispensing
Three questions cover the avoidances and cautions the approved label sets out. Select one option in each row.
Does the label indicate caution or avoidance in this adult?
Mapped to Sections 5.1, 7.1, 8.6 and 8.7 of the prescribing information.
1. Renal function
2. Hepatic function
3. Concomitant medicines and alcohol
Select one option in each of the three rows
The result reflects only the approved US prescribing information. It is not a substitute for clinical judgement or for the full label.
Reference: NEREUS prescribing information, revised March 2026.
How Nereus compares with existing options
No head-to-head trial of tradipitant against scopolamine, dimenhydrinate or meclizine has been published. The table below compares label characteristics across products studied in different populations and conditions, and should be read as a summary of documented properties rather than as comparative efficacy.
| Attribute | Nereus (tradipitant) | Transdermal scopolamine | Antihistamines (dimenhydrinate, meclizine) |
|---|---|---|---|
| Mechanism | NK-1 receptor antagonist | Muscarinic antagonist | H1 antagonist with anticholinergic activity |
| Access | Prescription only (US) | Prescription (US) | Largely over the counter |
| Regimen | Single dose, 60 min before travel, empty stomach | Patch applied before travel, multi-day | Repeat dosing during travel |
| Evidence for vomiting prevention | Two Phase 3 boat studies, 681 subjects | Long clinical use; varied trial base | Long clinical use; varied trial base |
| Effect on nausea | Not demonstrated — secondary endpoint not significant | Claimed for nausea and vomiting | Claimed for nausea and vomiting |
| Sedation | Somnolence 6% at 85 mg, 12% at 170 mg (placebo 4% and 6%) | Reported, with dry mouth and blurred vision | Commonly marked sedation |
| Driving warning on label | Yes | Yes | Yes |
| Anticholinergic burden | None at the receptor level | Yes | Yes |
| US cost per dose | USD 255 list, USD 85 direct cash | Generic, low | Generic, very low |
Nereus column from the prescribing information[2] and the sponsor’s launch announcement.[4]
The clearest point of separation is the absence of anticholinergic and antihistaminic receptor activity, which removes dry mouth, blurred vision and the confusion risk that limits scopolamine in older adults. Sedation, however, is not eliminated: Nereus carries the same class of driving and machinery warning as the agents it is positioned against, and somnolence at the 170 mg dose ran at twice the placebo rate.[2] For naval, aviation and other professional operators, that warning is the governing consideration.
United States availability and pricing
Vanda made Nereus commercially available across the United States on 1 May 2026, four months after approval.[4] Two channels operate in parallel:
- Retail pharmacy at a list price of approximately USD 255 per dose.
- Direct-to-consumer portal operated by the sponsor, at a cash price of USD 85 per dose for patients holding a valid prescription.
The three-to-one spread is a deliberate commercial structure rather than a discount programme. Motion sickness is episodic, self-limiting and rarely treated as a medical necessity by payers, so pricing the direct channel well below the list price routes demand away from the pharmacy benefit. Whether that model holds as utilisation data accumulate is an open question. Note that pharmacy price aggregators quote figures in the thousands of dollars because they describe a full 36-count bottle, not a course of treatment.
Availability in India
Tradipitant is not approved in India. No CDSCO new-drug permission, import registration or marketing authorisation appears on the public record as of August 2026. It cannot lawfully be imported for commercial sale, prescribed or stocked in Indian pharmacies.
A new drug already approved abroad reaches the Indian market under the New Drugs and Clinical Trials Rules, 2019, administered by the Central Licencing Authority (the DCGI).[11] The default requirement is a local clinical trial in the Indian population before marketing permission is granted, unless a waiver applies.
The Rule 101 waiver route
Under Rule 101 the DCGI may specify countries whose approvals permit a waiver of the local clinical trial requirement. An order dated 7 August 2024 named the United States, United Kingdom, Japan, Canada, Australia and the European Union.[12] The waiver is not automatic and is confined to five categories:
- orphan drugs for rare diseases;
- gene and cellular therapy products;
- new drugs for pandemic situations;
- new drugs for special defence purposes;
- new drugs offering significant therapeutic advance over the current standard of care.
Prevention of motion-induced vomiting fits none of these comfortably. It is not an orphan indication, not a gene or cell therapy, and not a pandemic use. The two arguable routes are special defence purposes — motion sickness is a documented operational-readiness issue for naval and aviation crews — and significant therapeutic advance, which is weakened by the unmet nausea endpoint and the absence of any head-to-head comparison against the generics already available in India. Each application is decided case by case at the DCGI’s discretion.
Without a waiver, an applicant would apply for permission to conduct a local Phase III study, complete it, and then file for import and marketing permission supported by the foreign approval package, the Indian trial data and India-specific labelling. On approval, the product would be a prescription medicine under Schedule H of the Drugs Rules, dispensable only against a registered medical practitioner’s prescription with the retailer maintaining the prescribed records.
There is a commercial question alongside the regulatory one. At the US cash price of USD 85 per dose — roughly INR 7,000 at prevailing rates — set against Indian dimenhydrinate and meclizine tablets retailing for a few rupees, the addressable market for a single-use travel prophylactic may not justify the cost of a filing. For products of this type, that commercial calculation has historically been the greater barrier. Drugs that have cleared the process are listed in the CDSCO new drugs list.
The wider tradipitant programme
Motion sickness is the only approved indication, and it was not the first Vanda pursued. The molecule’s development history is relevant to anyone assessing its future:
| Programme | Studies | Status |
|---|---|---|
| Motion sickness | Motion Syros, Motion Serifos (Phase 3) | Approved 30 Dec 2025; launched 1 May 2026 |
| Atopic dermatitis and pruritus | NCT03568331 (Phase 3, 375 subjects); NCT04140695 | Did not lead to approval; the second study was terminated |
| Gastroparesis | NCT04028492 (Phase 3, 992 subjects) | FDA issued a Complete Response Letter for NDA 218489 on 18 September 2024 citing lack of substantial evidence of effectiveness; the matter proceeded to a notice of opportunity for a hearing |
| GLP-1 receptor agonist nausea and vomiting | NCT06804603 (Phase 2, completed Oct 2025); Thetis, NCT07446439 (Phase 3, 280 participants) | Thetis began recruiting 27 March 2026 with primary completion scheduled December 2026[10] |
Trial records from ClinicalTrials.gov; the gastroparesis regulatory history from the public FDA docket.
The GLP-1 programme carries the larger commercial implication. Nausea and vomiting are the dominant reasons patients discontinue GLP-1 receptor agonists, and an adjunct that improves persistence would address a far larger population than motion sickness. The same caution the motion sickness data raises applies here: tradipitant’s demonstrated effect is on vomiting, so the Thetis primary endpoint will repay close reading when it reports.
Frequently asked questions
No. Tradipitant has no CDSCO new-drug permission, import registration or marketing authorisation in India as of August 2026, and it cannot lawfully be sold or stocked in Indian pharmacies. Bringing it to India would require either a local Phase III study followed by an import and marketing application under the New Drugs and Clinical Trials Rules 2019, or a discretionary waiver of the local trial requirement under Rule 101, which is limited to five narrow categories that motion sickness does not comfortably fit.
The sponsor lists a standard price of approximately USD 255 per dose through retail pharmacy channels, and a cash price of USD 85 per dose through its own direct-to-consumer portal for patients holding a valid prescription. Both figures are per dose rather than per capsule, which matters because a 170 mg dose is two 85 mg capsules. Prices quoted by pharmacy price aggregators run into thousands of dollars because they describe a full 36-count bottle rather than a course of treatment.
No, and this is the most important limitation on the label. Worst nausea score was a secondary endpoint in both pivotal studies, and the differences between tradipitant and placebo did not reach statistical significance in either one. The approved indication is worded as prevention of vomiting induced by motion, not prevention of motion sickness. A patient can take the drug, avoid vomiting, and still feel substantially nauseated during the journey.
One 85 mg capsule, or two capsules for the 170 mg dose, taken approximately 60 minutes before the event expected to cause motion-induced vomiting, on an empty stomach at least one hour before or two hours after a full meal. The food restriction is not a formality: a high-fat meal raises peak concentration roughly fivefold at 85 mg and sevenfold at 170 mg, and delays the time to peak by two hours or more, which both increases the chance of drowsiness and can push the peak past the start of travel.
The label warns that Nereus may impair the mental or physical abilities required to drive a motor vehicle or operate heavy machinery, and that concomitant CNS depressants and strong CYP3A4 inhibitors may increase this effect. Somnolence was reported in 6 percent of subjects at 85 mg and 12 percent at 170 mg, against 4 percent and 6 percent on placebo. Patients should not drive until they know how the drug affects them, and should be counselled specifically about alcohol, which adds to the sedative effect even though it barely changes drug exposure.
Nereus is first-in-indication rather than first-in-class. NK-1 receptor antagonism has been an approved mechanism in the United States since aprepitant was cleared in 2003 for chemotherapy-induced nausea and vomiting, with rolapitant and netupitant following in the same class. What is new is the application of that mechanism to motion sickness, which had seen no new pharmacologic option in over forty years. The approval also came through standard review of a full NDA rather than an accelerated pathway, since the pivotal endpoint was a directly observed clinical outcome rather than a surrogate marker.
Summary for practitioners
- Indication: prevention of vomiting induced by motion, in adults only.
- Dose: 85 mg or 170 mg once, 60 minutes before travel, fasted. Maximum one dose in 24 hours. Only the 85 mg capsule is supplied, so 170 mg is two capsules.
- Principal limitation: nausea was not significantly reduced. Set the expectation before dispensing.
- Avoidances on the label: severe renal impairment (eGFR 29 or below) and hepatic impairment of any degree.
- Counselling priorities: empty stomach, timing, and the driving warning, particularly alongside alcohol or a strong CYP3A4 inhibitor.
- India: not approved, and not lawfully available.
Bringing a foreign-approved drug into India?
Import registration, marketing permission, Rule 101 waiver strategy and India-specific labelling each carry their own failure modes. We advise Indian manufacturers and importers on CDSCO submissions.
References
- US Food and Drug Administration, Center for Drug Evaluation and Research. Novel Drug Approvals for 2025. Silver Spring (MD): FDA; 2026. Available from: fda.gov. Accessed August 2026.
- Vanda Pharmaceuticals Inc. NEREUS (tradipitant) capsules, for oral use: highlights of prescribing information. NDA 220152. Washington (DC): Vanda Pharmaceuticals; revised March 2026. Available from: assets.vandapharma.com. Accessed August 2026.
- Vanda Pharmaceuticals Inc. Vanda Pharmaceuticals announces FDA approval of NEREUS (tradipitant) for the prevention of vomiting induced by motion. Press release. 30 December 2025. Available from: prnewswire.com. Accessed August 2026.
- Vanda Pharmaceuticals Inc. Vanda Pharmaceuticals announces US commercial availability of NEREUS (tradipitant). Press release. 1 May 2026. Available from: prnewswire.com. Accessed August 2026.
- Vanda Pharmaceuticals. Motion Syros: a randomized, double-blind, placebo-controlled study of tradipitant in subjects affected by motion sickness during travel. ClinicalTrials.gov identifier NCT04327661. Available from: clinicaltrials.gov. Accessed August 2026.
- Vanda Pharmaceuticals. Motion Serifos: a randomized, double-blind, placebo-controlled study of tradipitant in participants affected by motion sickness during travel. ClinicalTrials.gov identifier NCT05903924. Available from: clinicaltrials.gov. Accessed August 2026.
- Vanda Pharmaceuticals. Motion Sifnos: a randomized, double-blind, placebo-controlled Phase 2 study of tradipitant in subjects affected by motion sickness during travel. ClinicalTrials.gov identifier NCT03772340. Available from: clinicaltrials.gov. Accessed August 2026.
- Vanda Pharmaceuticals. Motion Delos: an open-label study of the safety and efficacy of tradipitant in participants affected by motion sickness during travel. ClinicalTrials.gov identifier NCT06138613. Available from: clinicaltrials.gov. Accessed August 2026.
- Merck & Co. EMEND (aprepitant) capsules: prescribing information. NDA 21-549. Whitehouse Station (NJ): Merck; 2003. Available from: accessdata.fda.gov. Accessed August 2026.
- Vanda Pharmaceuticals. The Thetis Study: a randomized, double-blind, placebo-controlled study of tradipitant on nausea and vomiting after GLP-1R agonist administration. ClinicalTrials.gov identifier NCT07446439. Available from: clinicaltrials.gov. Accessed August 2026.
- Ministry of Health and Family Welfare, Government of India. New Drugs and Clinical Trials Rules, 2019. New Delhi: Central Drugs Standard Control Organisation. Available from: cdsco.gov.in. Accessed August 2026.
- National Institute of Allergy and Infectious Diseases. ClinRegs: India — DCGI order specifying names of countries under Rule 101 of the New Drugs and Clinical Trials Rules 2019, dated 7 August 2024. Bethesda (MD): NIAID. Available from: clinregs.niaid.nih.gov. Accessed August 2026.
Disclaimer. This article is technical and educational content for pharmaceutical and healthcare professionals. It is not medical advice, prescribing guidance or investment advice, and it is not a substitute for the full approved prescribing information, which practitioners must consult before prescribing or dispensing. Regulatory positions, pharmacopoeial texts and Indian statutory instruments change frequently and may vary by state; verify the current position with the relevant authority before acting.
Verified against the NEREUS prescribing information revised March 2026. Last reviewed 11 August 2026.
