Delamanid Drug Asset Due Diligence Report 2026: Clinical, IP, Market, Deals, and Go/No-Go
This Delamanid Drug Asset Due Diligence Report was built with PatSnap Life Sciences MCP workflows. Drug & Asset MCP establishes identity, ownership and stage; Clinical Trials MCP checks design, endpoints and readouts; Company & Deal Intelligence MCP reconstructs transaction precedent. Explore the MCP servers used in this report.
Decision date: 15 July 2026. Currency fields are presented in US$ millions as returned by the deal dataset. This is a screening memorandum, not legal, medical, patent or investment advice.
Approved
Highest phase
45
Registered trials
25
Result records
2
Matched deals
Executive recommendation: GO
Decision memo
Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.
The central underwriting question is whether Delamanid can convert its Small molecule drug profile and Not disclosed biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.
1. Asset identity and development status
| Asset | Delamanid (query alias: delamanid) |
|---|---|
| Modality / target | Small molecule drug; Not disclosed; Cell wall inhibitors, Mycolic acid synthesis inhibitors |
| Highest global status | Approved |
| Originator | Otsuka Holdings Co., Ltd. |
| Active developers | Otsuka Novel Products GmbH, Otsuka Pharmaceutical Co., Ltd., Otsuka Holdings Co., Ltd. |
The MCP disease footprint includes Tuberculosis, Pulmonary Tuberculosis, Tuberculosis, Multidrug-Resistant. The highest-phase flag is a useful orientation point, but the licensing case depends on indication-level evidence and rights, not the global label alone.
2. Clinical program: design and endpoint audit
| Registry | Phase | Status | Enrollment | Lead primary endpoint |
|---|---|---|---|---|
| NCT07675954 | Phase 3 | Not yet recruiting | 294 | Favourable outcome at 12 months after treatment discontinuation |
| NCT07129629 | Phase 2 | Not yet recruiting | 45 | Early Bactericidal Activity CFU 0-14 (EBA CFU₀-₁₄) |
| ChiCTR2500108732 | Phase 2 | Not yet recruiting | 20 | The sputum culture conversion rate (SCC, %) in all groups after 8 weeks of treatment |
The trial set should be diligenced for randomization, comparator relevance, endpoint hierarchy, analysis population, multiplicity, geographic mix and readout timing. For early-stage studies, safety and dose selection can be as decision-critical as response rate.
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3. Clinical readouts: what is known
A Phase I/II Open-Label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination With Optimized Multidrug Background Regimen (OBR) for Multidrug-Resistant Tuberculosis (MDR-TB) in Children With MDR-TB With and Without HIV
Phase 1/2; n=37; evaluation: not stated. Reported fields: -; Percentage of Participants With Adverse Events of ≥ Grade 3 Severity = 25.0 percentage of participants (95% Confidence Interval, 5.5 - 57.2); Percentage of Participants With Adverse Events of ≥ Grade 3 Severity = 18.2 percentage of participants (95% Confidence Interval, 2.3 - 51.8)
A Phase 2b/c, Multi-Arm, 2-Stage, Duration Randomized Trial of the Efficacy and Safety of Two to Four Months Treatment With Regimens Containing Bedaquiline, OPC-167832, and Sutezolid, Plus Either Pretomanid or Delamanid, in Adults With Pulmonary Tuberculosis
Phase 2; n=93; evaluation: not stated. Reported fields: -; ≥ Grade 3 TEAEs At Week 19 = 16.7 percentage of participants ; -
Efficacy and safety of a 4-month quabodepistat, delamanid, and bedaquiline regimen for drug-susceptible pulmonary tuberculosis: a multicentre, open-label, randomised, proof-of-concept, non-inferiority, phase 2b/c trial
Phase 2/3; n=121; evaluation: Positive. Reported fields: SCC(end of treatment) = 96.0 % ( 90.1 - 98.9); -; SCC(end of treatment) = 100.0 % ( 83.2 - 100.0)
These fields are structured evidence signals, not a substitute for statistical review. The next diligence pass should reconcile denominators, confidence intervals, follow-up, censoring, dose cohorts and treatment-emergent toxicity against the original abstract, registry and protocol.
4. Market and competitive position
Delamanid addresses Tuberculosis, Pulmonary Tuberculosis, Tuberculosis, Multidrug-Resistant. Commercial attractiveness rests on addressable biomarker-positive patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Small molecule drug—must demonstrate a benefit large enough to offset class-specific safety and operational costs.
The strongest market-validation signal in this screen is partner behavior: 2 matched transaction record(s) indicate that sophisticated counterparties have assigned strategic value to the asset or its rights. That does not establish net present value; probability of success, remaining R&D spend, royalties, cost sharing and territorial scope still need modeling.
5. Transaction precedent and economics
| Date | Transaction | Phase at deal | Disclosed economics |
|---|---|---|---|
| 2017-08-24 | Otsuka, Mylan to Commercialize Delamanid | Approved | Financial terms not disclosed |
| 2017-07-18 | Otsuka and R-Pharm Announce Licensing Agreement to Commercialize Deltyba™ (Delamanid) for Multidrug-Resistant Tuberculosis (MDR-TB) in Russia and CIS Countries | Approved | Financial terms not disclosed |
Headline values are not directly comparable. Diligence should normalize upfront cash, equity, development and sales milestones, tiered royalties, opt-in mechanics, cost sharing, change-of-control clauses and geography.
6. IP and freedom-to-operate screen
The milestone feed surfaced a patent-application signal described as “Delamanid-containing solid dispersion”. The milestone feed surfaced a patent-application signal described as “Crystal forms of delamanid, active drug containing crystal forms and pharmaceutical composition”. The milestone feed surfaced a patent-application signal described as “Delamanid-containing composition”.
The claim chart should separately test composition or sequence coverage, formulation and dosing, indication and biomarker claims, combinations, manufacturing know-how, prosecution history, term extensions and third-party blocking rights. Confirm that licensed patents, data and know-how track every granted territory and field.
7. Principal risks and diligence gates
- Therapeutic index across KRAS/BRAF mutation subgroups
- On-target toxicity and adaptive MAPK resistance
- Lack of matched efficacy results in the current MCP result set
Cross-functional diligence should also test CMC comparability, supply chain, pharmacovigilance, regulatory correspondence, data integrity, investigator concentration, partner obligations and change-of-control restrictions.
8. Final go/no-go memorandum
GO
Advance diligence: development maturity and available evidence support continued investment, subject to indication-specific safety, IP, and commercial gates.
Required pre-signing gates: reproduce key efficacy analyses; complete an indication-specific safety review; run a full patent-family and freedom-to-operate search; model risk-adjusted economics by territory; and reconcile all rights, sublicenses and encumbrances.
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Data provenance: PatSnap Drug & Asset MCP, Clinical Trials MCP, and Company & Deal Intelligence MCP; accessed 15 July 2026. Counts and status fields may change as source records update.
