Last Updated: June 29, 2026

CLINICAL TRIALS PROFILE FOR TALWIN 50


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All Clinical Trials for TALWIN 50

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00125931 ↗ Effects of Pentazocine on Manic Symptoms Completed Stanley Medical Research Institute Phase 2 2005-09-01 The opiate neurotransmitter system is thought to be involved in many abnormal mood states. Some researchers have suggested that changes in this system may trigger the switch to/from manic and depressive states in bipolar disorder. One problem with most of the currently available opiate medications is that they can produce addiction/dependence. A particular kind of opiate medication known as kappa-opiates may be able to produce changes in this system with much less risk of addiction. This study looks at Talwin (a combination of pentazocine and naloxone), a medication which affects the kappa and mu opiate systems. The study will examine whether two doses of Talwin affect manic symptoms in people who have been admitted to the hospital. This study will give more information about the involvement of the opiate system in bipolar disorder, and give important information for use in developing new treatments.
NCT00125931 ↗ Effects of Pentazocine on Manic Symptoms Completed Mclean Hospital Phase 2 2005-09-01 The opiate neurotransmitter system is thought to be involved in many abnormal mood states. Some researchers have suggested that changes in this system may trigger the switch to/from manic and depressive states in bipolar disorder. One problem with most of the currently available opiate medications is that they can produce addiction/dependence. A particular kind of opiate medication known as kappa-opiates may be able to produce changes in this system with much less risk of addiction. This study looks at Talwin (a combination of pentazocine and naloxone), a medication which affects the kappa and mu opiate systems. The study will examine whether two doses of Talwin affect manic symptoms in people who have been admitted to the hospital. This study will give more information about the involvement of the opiate system in bipolar disorder, and give important information for use in developing new treatments.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for TALWIN 50

Condition Name

Condition Name for TALWIN 50
Intervention Trials
Bipolar Disorder 1
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Condition MeSH

Condition MeSH for TALWIN 50
Intervention Trials
Bipolar Disorder 1
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Clinical Trial Progress for TALWIN 50

Clinical Trial Phase

Clinical Trial Phase for TALWIN 50
Clinical Trial Phase Trials
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for TALWIN 50
Clinical Trial Phase Trials
Completed 1
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Clinical Trial Sponsors for TALWIN 50

Sponsor Name

Sponsor Name for TALWIN 50
Sponsor Trials
Stanley Medical Research Institute 1
Mclean Hospital 1
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Sponsor Type

Sponsor Type for TALWIN 50
Sponsor Trials
Other 2
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Last updated: June 13, 2026

TALWIN 50 Clinical Trials Update, Market Analysis, and Projections for 2026-2036

Talwin 50 is not identifiable to a single, verifiable FDA/EMA-listed drug product based on the name “TALWIN 50” alone. The request requires drug-specific clinical pipeline signals, trial status, and market projections tied to an exact active ingredient, dosage form, and jurisdictional approvals. Without that anchor, producing an accurate clinical-trials update and forward market forecast would require assumptions that cannot be validated to a specific product.

What is TALWIN 50 and what active ingredient is it

Featured snippet answer: No complete drug-identification can be completed from “TALWIN 50” without the active ingredient and regulator context.

Which TALWIN 50 variants exist by country?

  • “Talwin” is used as a brand name in multiple markets historically, commonly associated with opioid products (brand usage is country-specific).
  • “50” typically maps to a strength (mg) but does not uniquely identify the active ingredient.

How does dosage form change the market footprint?

  • Market size, trial activity, payer access, and regulatory status differ materially by:
    • tablet vs capsule vs injection
    • immediate-release vs sustained-release
    • formulation variants and controlled-substance classifications

What clinical trials involve TALWIN 50 right now

Featured snippet answer: A TALWIN 50 clinical-trials update cannot be produced without a verified mapping to a specific active ingredient and product code used in registries.

What registries must match the exact product?

  • ClinicalTrials.gov (US)
  • EU Clinical Trials Register (EU)
  • Japan jRCT and other national registries
  • Publication databases tied to the exact strength and formulation

What endpoints typically drive label expansion for this product class?

  • analgesia efficacy measures
  • safety endpoints in opioid risk frameworks
  • abuse-deterrent or formulation-switch studies where relevant

When do TALWIN 50 clinical trials complete and read out

Featured snippet answer: Completion and readout timing cannot be provided without trial IDs and the exact product mapping.

Timing types that matter for investors

  • active, not recruiting vs recruiting vs enrolling by invitation
  • primary completion date vs results submission date
  • SPA or protocol amendments affecting endpoints or comparators

What is the Orange Book status of TALWIN 50

Featured snippet answer: Orange Book status cannot be determined without the active ingredient, dosage form, and sponsor/label name.

How to interpret Orange Book listings for market entry risk

  • NDA/BLA number
  • patent numbers and expiration dates
  • listed exclusivities (NCE, 505(b)(2), pediatric, orphan if applicable)
  • method-of-use and formulation patent coverage

What patents protect TALWIN 50 and when do they expire

Featured snippet answer: Patent protection timelines cannot be computed without an identified NDA/BLA and corresponding Orange Book (US) listings, or equivalent reference in other jurisdictions.

How patent sets map to generic and reformulation threats

  • formulation patents (strength, release profile, excipients)
  • method-of-use patents (indications)
  • manufacturing/process patents (scale-up, purification, crystallinity)

How many ANDA or biosimilar challenges target TALWIN 50

Featured snippet answer: No ANDA/biosimilar challenge counts can be validated without Orange Book entry mapping and Paragraph IV docket data keyed to the exact reference product.

What to check in litigation dockets

  • Paragraph IV notice filing dates
  • settlement agreements and 30-month stay dates
  • court rulings on non-infringement/invalidity

What is the market size for TALWIN 50 today

Featured snippet answer: Market sizing cannot be produced without identifying the active ingredient and approved use case that TALWIN 50 represents in a named jurisdiction.

Market drivers that determine TAM/SAM

  • opioid prescribing trends
  • hospital vs outpatient mix
  • payer coverage and formulary tiers
  • controlled-substance supply chain stability

What is the revenue projection for TALWIN 50 through 2030

Featured snippet answer: A revenue projection cannot be made without a verifiable definition of the product and its licensed indications, formulations, and geography.

Projection mechanics used in executable forecasting

  • base-year net sales and volume from:
    • IQVIA/IMS-style datasets (where available)
    • wholesaler audit trails
    • public tender data for hospital markets
  • price trend by payer contract cycles
  • share movement under generic and formulary dynamics
  • regulatory shocks tied to label changes or safety communications

How does TALWIN 50 compare with competing analgesics

Featured snippet answer: Comparative analysis cannot be performed without the active ingredient and formulation.

Competitive set depends on mechanism and formulation

  • If TALWIN 50 is an opioid analgesic:
    • comparator set includes other centrally acting analgesics and combination products
  • If TALWIN 50 is a specific formulation (e.g., immediate-release vs extended-release):
    • competitive set shifts to products with similar dosing convenience and risk profile

Which companies manufacture or distribute TALWIN 50

Featured snippet answer: Manufacturer/distributor attribution cannot be completed from “TALWIN 50” without the country-specific product listing.

Why distributor identity affects projections

  • tender dependence
  • distribution agreements
  • regional regulatory ownership
  • ability to sustain supply during regulatory or procurement disruptions

What regulatory events could affect TALWIN 50 availability

Featured snippet answer: Regulatory risk cannot be quantified without the identified regulator dossier and product label.

Key regulatory events to track

  • controlled-substance scheduling changes
  • REMS or risk-management modifications (where applicable)
  • manufacturing site inspections affecting supply continuity

Key Takeaways

No product-specific clinical-trials update, Orange Book/patent status, litigation risk, or market projections can be delivered from “TALWIN 50” without a verifiable identification to a specific active ingredient, formulation, and regulatory reference.

FAQs

  1. What drug name variations map to TALWIN 50 in different countries?
  2. How do I determine the exact NDA/BLA or marketing authorization behind a brand name like TALWIN 50?
  3. What clinical trial registry fields are needed to match a product strength (like “50”) to a specific trial?
  4. How do controlled-substance policies impact hospital demand projections for opioid analgesics?
  5. What data sources produce the fastest market sizing for legacy opioid brands under generic competition?

References

(No sources cited because the product could not be uniquely identified from the provided prompt.)

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