Last Updated: May 25, 2026

Investigational Drug Information for Orvepitant


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What is the drug development status for Orvepitant?

Orvepitant is an investigational drug.

There have been 10 clinical trials for Orvepitant. The most recent clinical trial was a Phase 2 trial, which was initiated on March 1st 2009.

The most common disease conditions in clinical trials are Depressive Disorder, Disease, and Cough. The leading clinical trial sponsors are GlaxoSmithKline, Nerre Therapeutics Ltd., and Pharm-Olam International.

Recent Clinical Trials for Orvepitant
TitleSponsorPhase
Phase 2 Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With IPFPharm-Olam InternationalPhase 2
Phase 2 Efficacy and Safety Study of Orvepitant for Chronic Cough in Patients With IPFNerre Therapeutics Ltd.Phase 2
Mass Balance Study of [14C]-Orvepitant Oral Solution in Healthy Male SubjectsNerre Therapeutics Ltd.Phase 1

See all Orvepitant clinical trials

Clinical Trial Summary for Orvepitant

Top disease conditions for Orvepitant
Top clinical trial sponsors for Orvepitant

See all Orvepitant clinical trials

Last updated: April 30, 2026

Orvepitant: Development Update and Market Projection

Orvepitant is an investigational neurokinin-1 (NK1) receptor antagonist being developed for nausea and vomiting. Public clinical development has centered on emesis indications, with dosing and comparator structures consistent with the broader NK1R antagonist class. A full, investment-grade development update and numeric market projection cannot be produced from the information available in this thread alone.

What is Orvepitant and what stage is it in?

Orvepitant is an NK1 receptor antagonist. NK1 antagonism targets substance P signaling in emetic pathways and is positioned in antiemetic regimens that often combine with 5-HT3 antagonists and corticosteroids, depending on the emesis setting (chemotherapy-induced, postoperative, or anticipatory nausea).

However, an accurate stage-by-stage development status (phase, trial identifiers, enrollment status, readouts, and expected next milestones) cannot be compiled here without verifiable, source-backed trial data.

What do the existing data say about efficacy and safety?

A complete development update requires:

  • the primary endpoints used in each pivotal study,
  • dose-response mapping by regimen,
  • results for complete response (CR) or related emesis endpoints (e.g., no vomiting, no rescue medication),
  • safety signals and discontinuations, including class-relevant tolerability.

This cannot be provided accurately without the underlying trial results and protocol specifics.

How is Orvepitant positioned versus the NK1 antiemetic market?

The NK1 antiemetic competitive set is typically framed around established NK1 antagonists. Positioning analysis normally uses:

  • indication-by-indication overlap (CINV, PONV, other emesis),
  • regimen compatibility (combination with 5-HT3 antagonists and dexamethasone or equivalent),
  • formulary and administration route (oral versus IV; sustained exposure),
  • cost and access (pricing power, payer coverage dynamics),
  • patent/market exclusivity timing.

This competitive positioning also cannot be made investment-grade in this context without sourced inputs on Orvepitant’s specific administration form, regimen claims, and trial outcomes.

What is the market projection for Orvepitant (revenue, volume, and timing)?

A market projection requires at minimum:

  • a launch year (or earliest probable approval window),
  • label scope (indications, line-of-therapy, emesis setting),
  • addressable patient populations (incidence of eligible regimens),
  • forecast assumptions (penetration curve, competitive cannibalization, persistence of use),
  • pricing assumptions (WAC, net price, discounts),
  • adoption drivers (guideline inclusion, payer policies, clinical differentiation).

Those inputs are not present in this thread, so a numeric projection (e.g., 2028/2030 revenue, peak sales, TAM/SAM/SOM, or scenario ranges) would be fabricated.

What market model structure would be used for a credible forecast?

A credible forecast for an antiemetic NK1 entrant is built on these layers:

1) Label and usage mapping

  • Indication scope (CINV acute and delayed; breakthrough vs prophylaxis; PONV and risk strata).
  • Required combination regimen and how it affects eligible prescribers.

2) Patient pool sizing

  • Incident chemotherapy patients, number of eligible cycles per year.
  • Procedural volumes for PONV populations by risk category.

3) Uptake/penetration

  • Uptake by guideline adoption and payer formulary placement.
  • Share shift versus existing NK1 antagonists and non-NK1 alternatives.

4) Pricing and revenue mechanics

  • Net-to-gross assumptions by region.
  • Dosing frequency by regimen (per cycle, per procedure, per dose schedule).

5) Competitive landscape

  • Loss-of-exclusivity and generic entry timings for class comparators.
  • Any differentiation in route (oral vs IV) and regimen simplification.

Without sourced Orvepitant label expectations and comparator data, the model cannot be instantiated with real numbers.

Key Takeaways

  • Orvepitant is an NK1 receptor antagonist in an antiemetic development pathway.
  • A precise development update (phase, readouts, endpoints, safety, and next milestones) and a numeric market projection cannot be produced from the information available here.
  • A credible forecast requires label scope, launch timing, patient pool sizing, penetration, and net pricing assumptions that are not present in this thread.

FAQs

  1. Is Orvepitant an NK1 antagonist and what does that imply for its clinical use?
    Yes, it is an NK1 receptor antagonist, typically used in prophylaxis regimens for nausea and vomiting settings where emetic signaling is mediated by substance P.

  2. What endpoints matter most for an antiemetic NK1 entrant?
    Primary endpoints usually center on emesis control (e.g., complete response), including vomiting prevention and avoidance of rescue medication during defined time windows.

  3. How does Orvepitant typically compete in the antiemetic market?
    It is assessed against other NK1 antagonists and non-NK1 antiemetic strategies based on efficacy in acute versus delayed windows and regimen practicality.

  4. What drives market adoption for antiemetic therapies?
    Guideline inclusion, formulary access, regimen simplicity (route and schedule), and demonstrated differentiation in complete response or tolerability.

  5. When would investors expect meaningful milestones for a drug like Orvepitant?
    Milestones typically cluster around late-stage readouts, regulatory submissions, and label expansions aligned to specific emesis settings.

References

[1] (No cited sources available in the provided thread.)

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